BEST ARTICLE: 2010-06-13

Thursday, June 17, 2010

Documentation of iron stores in patients with myelodysplastic syndrome (MDS) (Measure 68)

If patient has Myelodysplastic syndrome (ICD-9 diagnosis codes: 238.72, 238.73, 238.74, 238.75 AND CPT E/M service codes: 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99241, 99242, 99243, 99244 and 99245), recommend to calculate body’s iron stores before starting treatment with erythropoietin. To be effective erythropoietin requires that adequate iron stores be present due to iron’s importance in red-blood-cell synthesis. Iron deficiency presents a major limitation to the efficacy of erythropoietin therapy.

DESCRIPTION:

Percentage of patients aged 18 years and older with a diagnosis of MDS (myelodysplastic syndrome) who are receiving erythropoietin therapy with documentation of iron stores prior to initiating erythropoietin therapy

GUIDELINE:

If patient has Myelodysplastic syndrome, recommend to calculate body’s iron stores before starting treatment with erythropoietin. To be effective erythropoietin requires that adequate iron stores be present due to iron’s importance in red-blood-cell synthesis. Iron deficiency presents a major limitation to the efficacy of erythropoietin therapy.

Reference:

NCCN Clinical practice guidelines in oncology. Myelodysplastic syndromes. V-2-2008 http://www.nccn.org/professionals/physician_gls/PDF/mds.pdf

Goldberg H, Lusk E, Moore J, et al: Survey of exposure to genotoxic agents in primary myelodysplastic syndrome: correlation with chromosome patterns and data on patients without hematological disease. Cancer Res 1990 Nov 1; 50(21): 6876-81

Westbrook, CA, Hsu, WT, Chyna, B, et al. Cytogenetic and molecular diagnosis of chromosome 5 deletions in myelodysplasia. Br J Haematol 2000; 110:847.
Jacobs, RH, Cornbleet, MA, Vardiman, JW, et al. Prognostic implications of morphology and karyotype in primary myelodysplastic syndromes. Blood 1986; 67:1765.
Rose, EH, Abels, RI, Nelson, RA, et al. The use of r-HuEpo in the treatment of anaemia related to myelodysplasia (MDS). Br J Haematol 1995; 89:831.

Treatment of multiple myeloma with bisphosphonates (Measure 69)

If patient has multiple myeloma (ICD-9 diagnosis code: 203.00

AND CPT E/M service codes: 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99241, 99242, 99243, 99244 and 99245) and has bone disease, including osteopenia recommend intravenous bisphosphonates monthly. Bisphosphonates can inhibit bone resorption by reducing the number and activity of osteoclasts and therefore could reduce pain and bone fractures in people with multiple myeloma.

DESCRIPTION:

Percentage of patients aged 18 years and older with a diagnosis of multiple myeloma, not in remission, who were prescribed or received intravenous bisphosphonate therapy within 12 months

GUIDELINE

If patient has multiple myeloma and has bone disease, including osteopenia recommend intravenous bisphosphonates monthly. Multiple myeloma is a disease characterized by bone destruction, in the form of diffuse osteopenia and/or osteolytic lesions, which develop in 85% of patients. Bisphosphonates can inhibit bone resorption by reducing the number and activity of osteoclasts and therefore could reduce pain and bone fractures in people with multiple myeloma

Reference:

Kyle RA, Yee GC, Somerfield MR, Flynn PJ, Halabi S, Jagannath S, Orlowski RZ, Roodman DG, Twilde P, Anderson K. American Society of Clinical Oncology 2007 clinical practice guideline update on the role of bisphosphonates in multiple myeloma. J Clin Oncol 2007 Jun 10;25(17):2464-72.
Smith A, Wisloff F, Samson D, UK Myeloma Forum, Nordic Myeloma Study Group, British Committee for Standards in Haematology. Guidelines on the diagnosis and management of multiple myeloma 2005. Br J Haematol 2006 Feb; 132(4):410-51.
NCCN Clinical practice guidelines in oncology. Multiple myeloma. V.1.2008

http://www.nccn.org/professionals/physician_gls/PDF/myeloma.pdf

217. Baseline Flow Cytometry in patients with CLL (Measure 70)

If patient has chronic Lymphocytic leukemia (ICD-9 diagnosis code: 204.10 AND CPT E/M service codes: 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99241, 99242, 99243, 99244 and 99245) recommend flow cytometric analysis. Due to the distinct pattern of protein antigens expressed in CLL, flow cytometry should be performed in order to confirm the diagnosis, correctly characterize the pathological cells, and determine prognosis. In some instances, flow cytometry may also offer additional therapeutically relevant information. Flow cytometric studies performed on patients with leukemic cell burden include kappa/lambda to assess clonality. Distinguishing CLL/SLL from mantle cell lymphoma is essential

DESCRIPTION:

Percentage of patients aged 18 years and older with a diagnosis of Chronic Lymphocytic Leukemia (CLL) who had baseline flow cytometry studies performed

GUIDELINE:

If patient has chronic Lymphocytic leukemia, recommend flow cytometric analysis. Due to the distinct pattern of protein antigens expressed in CLL, flow cytometry should be performed in order to confirm the diagnosis, correctly characterize the pathological cells, and determine prognosis. In some instances, flow cytometry may also offer additional therapeutically relevant information. Flow cytometric studies performed on patients with leukemic cell burden include kappa/lambda to assess clonality. Distinguishing CLL/SLL from mantle cell lymphoma is essential.

Reference

· Chronic lymphocytic leukemia: Recommendations for diagnosis, staging, and response criteria. International Workshop on Chronic Lymphocytic Leukemia. Ann Intern Med 1989; 110:236.

· Rai KR, Sawitsky A, Cronkite EP: Clinical staging of chronic lymphocytic leukemia. Blood 1975 Aug; 46(2): 219-34

· Zwiebel JA, Cheson BD: Chronic lymphocytic leukemia: staging and prognostic factors. Semin Oncol 1998 Feb; 25(1): 42-59

· National Cancer Institute. Chronic Lymphocytic Leukemia (PDQ®) Treatment: General Information. Retrieved on 2007-09-04.

· Chiorazzi N, Rai KR, Ferrarini M (2005). "Chronic lymphocytic leukemia". N. Engl. J. Med. 352 (8): 804-15.

Treatment of stage IC-III, ER/PR positive breast cancer with hormonal therapy (Measure 71)

If a female has stage 1c – III breast cancer (ICD-9 diagnosis codes: 174.0, 174.1, 174.2, 174.3, 174.4, 174.5, 174.6, 174.8, 174.9 AND CPT E/M service codes: 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99218, 99219, 99220, 99221, 99222, 99223, 99231, 99232, 99233, 99234, 99235, 99236, 99241, 99242, 99243, 99244, 99245, 99251, 99252, 99253, 99254, 99255) and tumor is positive for estrogen /progesterone receptors, recommend hormonal therapy. Based on results from multiple large randomized trials, adjuvant therapy for women with hormone receptor-positive breast cancer should include hormonal therapy in order to lower the risk of tumor recurrence.

DESCRIPTION:

Percentage of Stage IC-III, estrogen receptor (ER) or progesterone receptor (PR) positive, female breast cancer patients aged 18 years and older who are receiving tamoxifen or aromatase inhibitor (AI) at the time of the visit

GUIDELINE:

If a female has stage 1c – III breast cancer and tumor is positive for estrogen /progesterone receptors (ER/PR), recommend hormonal therapy. Based on results from multiple large randomized trials, adjuvant therapy for women with hormone receptor-positive breast cancer should include hormonal therapy in order to lower the risk of tumor recurrence.

References:

American Society of Clinical Oncology, Use of Aromatase Inhibitors As Adjuvant Therapy for Postmenopausal Women With Hormone Receptor-Positive Breast Cancer

http://www.asco.org/portal/site/ASCO/menuitem.c543a013502b2a89de912310320041a0/?vgnextoid=e64ef314170d8010VgnVCM100000ed730ad1RCRD&vgnextfmt=default

National Comprehensive Cancer Network Breast Cancer guideline recommendations for stage ICIII, ER/PR positive cancer: BINV-G, BINV-5, BINV-6, BINV-9.

http://www.nccn.org/professionals/physician_gls/default.asp

Treatment of stage III ca colon with chemotherapy (Measure 72)

If patient has stage III ca colon (ICD-9 diagnosis codes: 153.0, 153.1, 153.2, 153.3, 153.4, 153.5, 153.6, 153.7, 153.8, 153.9 AND CPT E/M service codes: 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99218, 99219, 99220, 99221, 99222, 99223, 99231, 99232, 99233, 99234, 99235, 99236, 99241, 99242, 99243, 99244, 99245, 99251, 99252, 99253, 99254, 99255), recommend adjuvant chemotherapy. Direct evidence from randomized controlled trials supports the use of adjuvant chemotherapy for patients with stage III colon cancer.

DESCRIPTION:

Percentage of stage III colon cancer patients aged 18 through 80 years who were prescribed chemotherapy

GUIDELINE

If patient has stage III ca colon, recommend adjuvant chemotherapy. Direct evidence from randomized controlled trials supports the use of adjuvant chemotherapy for patients with stage III colon cancer.

References

National Comprehensive Cancer Network Colon Cancer guideline recommendations for stage III cancer: COL-4.

http://www.nccn.org/professionals/physician_gls/default.asp

Otchy D, Hyman NH, Simmang C, Anthony T, Buie WD, Cataldo P, Church J, Cohen J, Dentsman F, Ellis CN, Kilkenny JW 3rd, Ko C, Moore R, Orsay C, Place R, Rafferty J, Rakinic J, Savoca P, Tjandra J, Whiteford M. Practice parameters for colon cancer. Dis Colon Rectum 2004 Aug; 47(8):1269-84.

220. Plan for chemotherapy in cancer treatment (Measure 73)

If patient has cancer (ICD-9 diagnosis codes: 140.0, 140.1, 140.3, 140.4, 140.5, 140.6, 140.8, 140.9, 141.0, 141.1, 141.2, 141.3, 141.4, 141.5, 141.6, 141.8, 141.9, 142.0, 142.1, 142.2, 142.8, 142.9, 143.0, 143.1, 143.8, 143.9, 144.0, 144.1, 144.8, 144.9, 145.0, 145.1, 145.2, 145.3, 145.4, 145.5, 145.6, 145.8, 145.9, 146.0, 146.1, 146.2, 146.3, 146.4, 146.5, 146.6, 146.7, 146.8, 146.9, 147.0, 147.1, 147.2, 147.3, 147.8, 147.9, 148.0, 148.1, 148.2, 148.3, 148.8, 148.9, 149.0, 149.1, 149.8, 149.9, 150.0, 150.1, 150.2, 150.3, 150.4, 150.5, 150.8, 150.9, 151.0, 151.1, 151.2, 151.3, 151.4, 151.5, 151.6, 151.8, 151.9, 152.0, 152.1, 152.2, 152.3, 152.8, 152.9, 153.0, 153.1, 153.2, 153.3, 153.4, 153.5, 153.6, 153.7, 153.8, 153.9, 154.0, 154.1, 154.2, 154.3, 154.8, 155.0, 155.1, 155.2, 156.0, 156.1, 156.2, 156.8, 156.9, 157.0, 157.1, 157.2, 157.3, 157.4, 157.8, 157.9, 158.0, 158.8, 158.9, 159.0, 159.1, 159.8, 159.9, 160.0, 160.1, 160.2, 160.3, 160.4, 160.5, 160.8, 160.9, 161.0, 161.1, 161.2, 161.3, 161.8, 161.9, 162.0, 162.2, 162.3, 162.4, 162.5, 162.8, 162.9, 163.0, 163.1, 163.8, 163.9, 164.0, 164.1, 164.2, 164.3, 164.8, 164.9, 165.0, 165.8, 165.9, 170.0, 170.1, 170.2, 170.3, 170.4, 170.5, 170.6, 170.7, 170.8, 170.9, 171.0, 171.2, 171.3, 171.4, 171.5, 171.6, 171.7, 171.8, 171.9, 172.0, 172.1, 172.2, 172.3, 172.4, 172.5, 172.6, 172.7, 172.8, 172.9, 173.0, 173.1, 173.2, 173.3, 173.4, 173.5, 173.6, 173.7, 173.8, 173.9, 174.0, 174.1, 174.2, 174.3, 174.4, 174.5, 174.6, 174.8, 174.9, 175.0, 175.9, 176.0, 176.1, 176.2, 176.3, 176.4, 176.5, 176.8, 176.9, 179, 180.0, 180.1, 180.8, 180.9, 181, 182.0, 182.1, 182.8, 183.0, 183.2, 183.3, 183.4, 183.5, 183.8, 183.9, 184.0, 184.1, 184.2, 184.3, 184.4, 184.8, 184.9, 185, 186.0, 186.9, 187.1, 187.2, 187.3, 187.4, 187.5, 187.6, 187.7, 187.8, 187.9, 188.0, 188.1, 188.2, 188.3, 188.4, 188.5, 188.6, 188.7, 188.8, 188.9, 189.0, 189.1, 189.2, 189.3, 189.4, 189.8, 189.9, 190.0, 190.1, 190.2, 190.3, 190.4, 190.5, 190.6, 190.7, 190.8, 190.9, 191.0, 191.1, 191.2, 191.3, 191.4, 191.5, 191.6, 191.7, 191.8, 191.9, 192.0, 192.1, 192.2, 192.3, 192.8, 192.9, 193, 194.0, 194.1, 194.3, 194.4, 194.5, 194.6, 194.8, 194.9, 195.0, 195.1, 195.2, 195.3, 195.4, 195.5, 195.8, 196.0, 196.1, 196.2, 196.3, 196.5, 196.6, 196.8, 196.9, 197.0, 197.1, 197.2, 197.3, 197.4, 197.5, 197.6, 197.7, 197.8, 198.0, 198.1, 198.2, 198.3, 198.4, 198.5, 198.6, 198.7, 198.81, 198.82, 198.89, 199.0, 199.1, 200.00, 200.01, 200.02, 200.03, 200.04, 200.05, 200.06, 200.07, 200.08, 200.10, 200.11, 200.12, 200.13, 200.14, 200.15, 200.16, 200.17, 200.18, 200.20, 200.21, 200.22, 200.23, 200.24, 200.25, 200.26, 200.27, 200.28, 200.80, 200.81, 200.82, 200.83, 200.84, 200.85, 200.86, 200.87, 200.88, 201.00, 201.01, 201.02, 201.03, 201.04, 201.05, 201.06, 201.07, 201.08, 201.10, 201.11, 201.12, 201.13, 201.14, 201.15, 201.16, 201.17, 201.18, 201.20, 201.21, 201.22, 201.23, 201.24, 201.25, 201.26, 201.27, 201.28, 201.40, 201.41, 201.42, 201.43, 201.44, 201.45, 201.46,201.47, 201.48, 201.50, 201.51, 201.52, 201.53, 201.54, 201.55, 201.56, 201.57, 201.58, 201.60, 201.61, 201.62, 201.63, 201.64, 201.65, 201.66, 201.67, 201.68, 201.70, 201.71, 201.72, 201.73, 201.74, 201.75, 201.76, 201.77, 201.78, 201.90, 201.91, 201.92, 201.93, 201.94, 201.95, 201.96, 201.97, 201.98, 202.00, 202.01, 202.02, 202.03, 202.04, 202.05, 202.06, 202.07, 202.08, 202.10, 202.11, 202.12, 202.13, 202.14, 202.15, 202.16, 202.17, 202.18, 202.20, 202.21, 202.22, 202.23, 202.24, 202.25, 202.26, 202.27, 202.28, 202.30, 202.31, 202.32, 202.33, 202.34, 202.35, 202.36, 202.37, 202.38, 202.40, 202.41, 202.42, 202.43, 202.44, 202.45, 202.46, 202.47, 202.48, 202.50, 202.51, 202.52, 202.53, 202.54, 202.55, 202.56, 202.57, 202.58, 202.60, 202.61, 202.62, 202.63, 202.64, 202.65, 202.66, 202.67, 202.68, 202.80, 202.81, 202.82, 202.83, 202.84, 202.85, 202.86, 202.87, 202.88, 202.90, 202.91, 202.92, 202.93, 202.94, 202.95, 202.96, 202.97, 202.98, 203.00, 203.01, 203.10, 203.11, 203.80, 203.81, 204.00, 204.01, 204.10, 204.11, 204.20, 204.21, 204.80, 204.81, 204.90, 204.91, 205.00, 205.01, 205.10, 205.11, 205.20, 205.21, 205.30, 205.31, 205.80, 205.81, 205.90, 205.91, 206.00, 206.01, 206.10, 206.11, 206.20, 206.21, 206.80, 206.81, 206.90, 206.91, 207.00, 207.01, 207.10, 207.11, 207.20, 207.21, 207.80, 207.81, 208.00, 208.01, 208.10, 208.11, 208.20, 208.21, 208.80, 208.81, 208.90, 208.91, 210.0, 210.1, 210.2, 210.3, 210.4, 210.5, 210.6, 210.7, 210.8, 210.9, 211.0, 211.1, 211.2, 211.3, 211.4, 211.5, 211.6, 211.7, 211.8, 211.9, 212.0, 212.1, 212.2, 212.3, 212.4, 212.5, 212.6, 212.7, 212.8, 212.9, 213.0, 213.1, 213.2, 213.3, 213.4, 213.5, 213.6, 213.7, 213.8, 213.9, 214.0, 214.1, 214.2, 214.3, 214.4, 214.8, 214.9, 215.0, 215.2, 215.3, 215.4, 215.5, 215.6, 215.7, 215.8, 215.9, 216.0, 216.1, 216.2, 216.3, 216.4, 216.5, 216.6, 216.7, 216.8, 216.9, 217, 218.0, 218.1, 218.2, 218.9, 219.0, 219.1, 219.8, 219.9, 220, 221.0, 221.1, 221.2, 221.8, 221.9, 222.0, 222.1, 222.2, 222.3, 222.4, 222.8, 222.9, 223.0, 223.1, 223.2, 223.3, 223.81, 223.89, 223.9, 224.0, 224.1, 224.2, 224.3, 224.4, 224.5, 224.6, 224.7, 224.8, 224.9, 225.0, 225.1, 225.2, 225.3, 225.4, 225.8, 225.9, 226, 227.0, 227.1, 227.3, 227.4, 227.5, 227.6, 227.8, 227.9, 228.00, 228.01, 228.02, 228.03, 228.04, 228.09, 228.1, 229.0, 229.8, 229.9, 230.0, 230.1, 230.2, 230.3, 230.4, 230.5, 230.6, 230.7, 230.8, 230.9, 231.0, 231.1, 231.2, 231.8, 231.9, 232.0, 232.1, 232.2, 232.3, 232.4, 232.5, 232.6, 232.7, 232.8, 232.9, 233.0, 233.1, 233.2, 233.3, 233.4, 233.5, 233.6, 233.7, 233.9, 234.0, 234.8, 234.9, 235.0, 235.1, 235.2, 235.3, 235.4, 235.5, 235.6, 235.7, 235.8, 235.9, 236.0, 236.1, 236.2, 236.3, 236.4, 236.5, 236.6, 236.7, 236.90, 236.91, 236.99, 237.0, 237.1, 237.2, 237.3, 237.4, 237.5, 237.6, 237.70, 237.71, 237.72, 237.9, 238.0, 238.1, 238.2, 238.3, 238.4, 238.5, 238.6, 238.71, 238.72, 238.73, 238.74, 238.75, 238.76, 238.79, 238.8, 238.9, 239.0, 239.1, 239.2, 239.3, 239.4, 239.5, 239.6, 239.7, 239.8, 239.9 AND CPT procedure codes: 96401, 96402, 96405, 96406, 96409, 96411, 96413, 96415, 96416, 96417, 96420, 96422, 96423, 96425, 96440, 96445, 96450, 96521, 96522, 96523, 96542, 96549 AND CPT E/M service codes: 99201, 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99218, 99219, 99220, 99221, 99222, 99223, 99231, 99232, 99233, 99234, 99235, 99236, 99241, 99242, 99243, 99244, 99245, 99251, 99252, 99253, 99254, 99255) for which chemotherapy is required, recommend making and documenting a plan for the amount of chemotherapy to be given including doses and time intervals. A documented plan for chemotherapy treatment is important for promoting adherence to evidence based care, improving safety, and enhancing coordination among providers.

DESCRIPTION:

Percentage of cancer patients for whom a plan for the amount of chemotherapy to be given was documented before the chemotherapy was administered

GUIDELINE

If patient has cancer for which chemotherapy is required, recommend making and documenting a plan for the amount of chemotherapy to be given including doses and time intervals. A documented plan for chemotherapy treatment is important for promoting adherence to evidence based care, improving safety, and enhancing coordination among providers.

References:

• NICCQ: Malin JL SE, Epstein AM, Adams J, Emanuel EJ, Kahn, K: Results of the National Initiative for Cancer Care Quality: How can we improve the quality of cancer care in the United States. J Clin Oncol 24:626-634, 2006

http://www.jco.org/cgi/content/abstract/24/4/626

• Breast cancer: chemotherapy treatment plan documented 63% overall, range 44-78% across 5 MSAs

• Colon cancer: chemotherapy treatment plan documented 53% overall, range 50-71% across 5 MSAs

221. Treatment Post operative radiotherapy after breast conserving surgery for ca breast (Measure 74)

If patient had ca breast and has undergone breast conserving surgery (ICD-9 diagnosis codes: 174.0, 174.1, 174.2, 174.3, 174.4, 174.5, 174.6, 174.8, 174.9 AND CPT E/M service codes: 99241, 99242, 99243, 99244 and 99245), recommend post operative radiation therapy. Data from multiple large randomized trials have demonstrated that the addition of radiation after breast conserving surgery in patients with invasive breast cancer lowers the risk of local recurrence. The Oxford meta-analysis of these studies has also detected an improvement in overall survival with the use of radiation therapy in this setting.

DESCRIPTION:

Percentage of invasive female breast cancer patients aged 18 through 70 years old who have undergone breast conserving surgery and who have received recommendation for radiation therapy within 12 months of the first office visit

GUIDELINE

If patient had ca breast and has undergone breast conserving surgery, recommend post operative radiation therapy. Data from multiple large randomized trials have demonstrated that the addition of radiation after breast conserving surgery in patients with invasive breast cancer lowers the risk of local recurrence. The Oxford meta-analysis of these studies has also detected an improvement in overall survival with the use of radiation therapy in this setting.

References:

National Comprehensive Cancer Network Breast Cancer guideline recommendations v2.2007, BINV-2. http://www.nccn.org/patients/patient_gls/_english/_breast/1_introduction.asp

Epidemiology

Most common malignancy of the biliary system.

􀂄 5th most common tumor of the GI tract

􀂄 Most common in the seventh or eighth decades

of life.

􀂄 Females to males: 3-4:1

􀂄 1.2 cases per 100,000

􀂄 Highest rates in Native Americans and South

Americans, Polish and North Indians

Pathology

Dysplasia to invasive carcinoma takes over 15 years.

􀂄 Macroscopically is divided into papillary, tubular or

nodular. Papillary less invasion to the liver and lymph

nodes.

􀂄 Most carcinomas are adenocarcinomas 80-95%, and

can be papillary, tubular, mucinous or signet cells.

􀂄 Less common types include: anaplasic (2-7%),

squamous cell (1-6%), and adenosquamous (1-4%).

Carcinoid, small-cell, malignant melanoma, lymphoma

and sarcomas are particularly rare.

Genetics

K-ras mutations in 39-59%. Increases to 50-

83% in patients with abnormal

pancreaticobiliary duct junction.

􀂄 P53 abnormalities are seen in 35-92% of GB

cancers.(S. Misra et al, Eur J Surg Oncol 26, 2000).

􀂄 Over-expression of p53 is associated with grade,

stage and presence of gallstones.

Clinical Presentation

Symptoms Proportion of patients

RUQ pain 82%

Weight loss 72%

Anorexia 74%

Nausea and vomiting 68%

RUQ mass 65%

Jaundice 44%

Abdominal distention 30%

Pruritus 20%

Hematemesis 2%

Melena 1%

Diagnosis

Only 8-10% are diagnosed preoperatively.

􀂄 Diagnosis is often challenging, no signs and

symptoms specific to gallbladder cancer.

􀂄 Most are incidental discovery during the OR.

Diagnosis

Ultrasonography: 80% accurate; part of the

initial assessment. Demonstrates polypoidal

mass without acoustic shadow with localized

thickening. Loss of GB/liver interface found in

advance cancer.

Limitation in diagnosis of involved nodes and

staging of the disease

􀂄 Endoscopic ultrasound improves diagnosis of

GB cancer and predicts depth of tumor.

Helpful for differential diagnosis of polypoid

lesions.

Diagnosis

CT Scan accurately detects GB abnormalities

and the extent of disease, direct infiltration into

adjacent tissues or vessels, nodal or distant

metastasis.

􀂄 MRI: tumors are hypodense in T1 images and

hyperdense in T2 images. Particularly useful for

visualizing invasion of the hepatoduodenal

ligament, portal vein encasement and lymph

node involvement.

Diagnosis

Selective angiography is very accurate for

detection of vessel encasement or

neovascularization.

􀂄 ERCP is helpful in planning surgery, because it

can show tumor growth in the intrahepatic ducts

or CBD.

􀂄 HIDA can show CBD obstruction or cystic duct

obstruction (rare in GB cancer).

􀂄 FNA ultrasound or CT guided most frequently

used for preop cytodiagnosis, has a sensitivity of

88%.

Diagnosis

Laparoscopy and biopsy are extremely useful for

assessment of peritoneal metastasis, extend of

the disease and suitability of surgery in patients

with locally advanced disease.

􀂄 Markers as CA 19-9 >20U/ml have 79.4%

sensitivity and 79.2% specific. CEA >4mcg/L

is 93% specific but only 50% sensitive.

Staging UICC/AJCC TNM

Primary tumor

Tx Primary tumor cannot be assessed.

T0 No evidence of primary tumor

Tis Carcinoma in situ

T1a Tumor invade lamina propria

Tib tumor invadesmuscle layer

T2 Tumor invades perimuscular connective tissue, no extension beyong serosa or into

liver.

T3 Tumor perforates serosa or directly invades the liver or other adjacent organs or

structure (stomach, duodenum, colon, pancreas, omentum, extrhepatic bile ducrs)

T4 Tumor invades main portal vein or hepatic artery or invades two or more extrahepatic

organs or structures.

Regional Nodes

Nx Regional nodes cannot be assessed

N0 No regional lymph no metastasis

N1 Regional Lymph nodes metastasis

Distant metastasis

Mx distant metastasis cannot be assessed

M0 no distant metastasis

M1 distant metastasis

Stage UICC/AJCC TNM

Staging group

Stage 0 Tis N0m0

Stage IA T1N0M0

Stage IB T2N0M0

Stage IIA T3N0M0

Stage IIB T1,T2,T3 N1M0

Stage III T4 Any N M0

Satge IV Any T Any N M1

Staging

Nevin’s classification:

􀂄 Stage I: mucosa only (45% 2yr survival)

􀂄 Stage II: muscularis (15%)

􀂄 Stage III: all layers (4%)

􀂄 Stage IV: lymph nodes (2%)

􀂄 Stage V: liver invasion, adjacent organs, distant

metastasis

Histology 2yr surv. Median surv.

Adenocarcinoma 14% 4 months

Papillary variant 47% 20 months

Mucinous Variant 12% 4 months

Squamous cell 9% 4 months

Adenosquamous 8% 3 months

Undifferentiated 0% 2 months

The only potentially curative therapy

􀂄 Surgical options:

􀂄 Simple cholecystectomy

􀂄 Radical or extended cholecystectomy

􀂄 Radical cholecystectomy with liver resection(segemental or

lobar)

􀂄 Radical cholecystectomy with extensive lymph-node

dissection

􀂄 Radical cholecystectomy with bile duct resection or

pancreaticoduodenectomy

􀂄 Bilio-enteric bypass

􀂄 Resection of port sites after laparoscopic cholecystectomy

Stage I: simple cholecystectomy

􀂄 Stage II: radical cholecystectomy (2-5cm wedge

resection of GB fossa and regional lymph node

dissection

􀂄 Stage III and above: controversial ( liver resection or

palliative bilioenteric bypass vs adjuvant

chemo/radiotherapy)

􀂄 If GB cancer is suspected during laparoscopic

cholecystectomy, recommend convertion to open

procedure.

􀂄 GB cancer suspected before surgery, laparoscopic

cholecystectomy should not be considered.

Surgical management

80-96% 5yr survival for T1 lesions with simple

cholecystectomy.

􀂄 15% lymph node metastasis in T1b lesions.

87% 10 yr survival with simple

cholecystectomy.(T. Wakai et al, Br J Surg 88, 2001).

􀂄 30-40% 5 yr survival for T2 lesions treated with

simple cholecystectomy(D.L.Barlett, et al, Ann Surg 224, 1996)

􀂄 80-90% 5yr survival for T2 and T3 lesions

treated with radical cholecystectomy.(Y.shirai et al, Ann

Surg 215, 1992).

􀂄 Re-exploration reveals residual tumor in 40-76%

of cases

Surgical management

Palliation for advance GB cancer:

􀂄 Segment II duct bilio-enteric bypass

􀂄 Endoscopic stenting

􀂄 Radiological stenting

􀂄 Duodenal or intestinal bypass for gastric outlet or

intestinal obstruction.

Radiotherapy

􀂄 Stage IV tumors treated with resection and

radiotherapy, 3yr survival of 10%.(Todoroki et al, World J

surg 15, 1991).

􀂄 Tumor control is rarely achieved by radiotherapy

alone.

􀂄 Brachytherapy via percutaneous transhepatic

approach is used for palliation of obstructive

jaundice due to bile duct obstruction.

Chemotherapy

34% response rate and 7 months response

duration with intra-arterial infusion of 5-FU and

mitomycin c.(Misra, et al, Reg Cancer Treat 5 ,1992).

􀂄 61% response rate with Gemcitabine and

Cisplatinum. Needs further studying.

Etiology and Outcome of Neonatal Seizures in a tertiary care nursery

Etiology and Outcome of Neonatal Seizures in a tertiary care nursery

Introduction:

Seizure is described as a paroxysmal behavior caused by hyper synchronous discharge of a group of neurons¹. Neonatal seizures refer to the paroxysmal activity occurring in first 28 days of life or up to 44 weeks conception age in an infant². They are often the first sign of neurological dysfunction in neonates³.

Neonatal seizures occur in 80-120 cases per 100,000 neonates per year and the highest incidence is in first 10 days of life¹. The underlying pathology is diverse and determines the immediate and long term outcome in terms of developmental impairment. It includes hypoxic ischemic encephalopathy, intracranial hemorrhage, infections and metabolic abnormalities. Determining the underlying etiology is critical and delay in treating the inciting pathology may adversely affect the final outcome. Western literature shows higher incidence of seizures related to hypoxic ischemic encephalopathy (65%) and intracranial hemorrhage (10%)^3,4. Repeated neonatal seizures lead to further brain injury. The probable mechanisms include hypoventilation causing further hypoxic injury, hypercarbia increasing cerebral blood flow with risk of intracranial hemorrhage, increased glycolysis causing hypoglycemia and excitatory amino acids causing excitotoxic brain injury. The etiology of neonatal seizures varies with socioeconomic environment and health facilities available. Pakistani studies point towards CNS infections (40 - 45.2%) and birth asphyxia (40 – 56%) being more common^{5, 6}. The duration of treatment and outcome also depends on the underlying cause⁷. Only limited studies are available regarding the outcome of the neonatal seizures according to the underlying pathology in developing countries like Pakistan.

In this study, I aim to determine the frequency of various etiological factors responsible for neonatal seizures at a tertiary care hospital in Lahore, Pakistan. Immediate outcome related to these underlying pathologies and outcome at 2 month and 4 months regarding seizure control as well as developmental and neurological deficits will be studied. It will help to establish the profile of etiological factors causing neonatal seizures in our set up and explain the prognosis more accurately.

Objective

1. To determine the frequency of various etiological factors causing neonatal seizures

2. To determine the outcome of neonatal seizures due to various etiological factors at 2 months and at 4 months.

Operational definitions:

Seizures

Any child less than 28 days presenting with a physical convulsion due to uncontrolled electrical activity in the brain.

Outcome;

Outcome in terms of no residual deficit, morbidity (residual focal neurological deficit including motor, hearing or visual impairment, developmental delay and uncontrolled seizures) and death.

Developmental milestones

These are tasks most children learn, or physical developments, that commonly appear in certain age ranges or major and minor social, emotional, physical, and cognitive skills acquired by children as they grow up

Material and methods:

Setting:

The study will be conducted at Neonatology unit of the Children’s Hospital and the Institute of Child Health, Lahore.

Duration of study

This study will be carried out over a period of 06 months after approval of synopsis

Sample size

The calculated sample size is 120 cases with 5% margin of error, 95% confidence level taking expected percentage of neonatal seizures 80 per 100,000. This sample size is calculated using web site www.openepi.com.

Sample technique

It will be purposive, non-probability sampling.
Sample Selection
Inclusion criteria
1) Age group up to 28 days.
2) Both male and female patients.
3) all preterm, term and post term patients
4) All patients with seizures for the first time.
Exclusion criteria
1. All patients with congenital anomalies
2. All patients who died before any etiology could be established either by history, examination or investigations
3. Patients who left against medical advice or lost to follow up
Study design:
It will be cross sectional descriptive observational study

All patients with seizures presenting to Neonatology unit of the Children’s Hospital and the Institute of Child Health, Lahore up to 28 days of life will be included in the study. Informed consent will be taken from parents of children and will be explained that the data will be used and published but confidentiality will be maintained.
Demographical data including age, gender, term will be recorded on a proforma. Detailed history regarding birth asphyxia, fever, fits and feeding will be taken and relevant examination will be carried out in all patients. Relevant investigations like cranial ultrasonography, cerebrospinal fluid examination, serum electrolytes including sodium, calcium, magnesium, random blood sugar, complete and differential blood counts, C-reactive proteins, blood culture, renal function tests will be carried out. CT scan or MRI brain will be conducted in patients with equivocal cranial ultrasound study. Electroencephalography will be recorded if no metabolic or structural lesion could be detected. All the results will be recorded on the proforma. All the patients will be followed up at 2 months and 4 months regarding their developmental assessment and outcome. Developmental assessment shall be made using ___________.

DATA ANALYSIS

The data will be entered on SPSS v. 12.0 and analyze through its statistical package. The variables to be analyzed will include age, gender, etiological factors and outcome. Quantitative variables like age will be presented by calculating mean and standard deviation. Qualitative variables like gender, etiological factors, and outcome will be presented by calculating frequencies and percentages. Comparison will be made between the etiological factors and outcome using Chi square test for test of significance. P value >

References:

1. Volpe JJ. Hypoxic-Ischemic Encephalopathy: Biochemical and Physiological Aspects. In: Neurology of the Newborn 5th ed. Mumbai: Elsevier Health Sciences; 2008. p211-59.
2. John PTC, Elia M, Engel J, Guerrini R, Mizrahi EL, Mosh´e SL et al. Proposal of an algorithm for diagnosis and treatment of neonatal seizures in developing countries. Epilepsia 2007; 48:1158–64.
3. Rone GM, Buckley D, Penney S, Streiner DL. Long-term prognosis in children with neonatal seizures. Neurology 2007;69:1816-22
4. Blume HK, Loch CM, Li CI. Neonatal encephalopathy and socioeconomic status - Population-based case-control study. Arch Pediatr Adolesc Med. 2007; 161:663-8
5. Parkash J, Das N. Pattern of admissions to neonatal unit. J Coll Physicians Surg Pak 2005;15:341-4.
6. Butt TK, Maqbool S, Ali L, Hamid H. Neonatal seizures - etiology, treatment and outcome. Pak Paed J 2005; 29:151-6.
7. Ronen GM, Buckley D, Penney S, Trenier DL. Long-term prognosis in children with neonatal seizures; a population-based study. Neurology 2007; 69:1816.

PROFORMA

NAME:___________________ FATHER’S NAME:___________________

AGE: PRETERM FULL TERM

>

>7M 11-20 DAYS

21-28 DAYS

GENDER:- MALE FEMALE

ADDRESS:_______________________________________________________

PHONE NUMBER: _________________________________

DATE OF ADMISSION: _____________________________

DATE OF DISCHARGE: _____________________________

PRESENTING COMPLAINTS:____________________________________________

Etiology :

EARLY ONSET SEIZURES (O-3^RD DAY OF LIFE)

LATE ONSET SEIZURES (4^TH-28^TH DAY OF LIFE)

Perinatal Asphyxia Intracranial Hemorrhage

Metabolic Abnormalities

Hypoglycemia Hyponatremia Hypernatremia

Hypocalcemia Hypomagnesemia

Infections

Meningitis Sepsis TORCH

Kernicterus Tetnus neonatorum Familial neonatal seizures

Investigations

CBC: Hb WBC Platelets CRP

S/E: Na Ca⁺ Mg⁺ BSR

RFT’s: BUN S/Cr

Blood Culture: Lumbar Puncture:

Crainal Ultrasound:

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