LONG TERM PATIENT EVALUATION STUDY CARCINOMAS, DYSPLASIAS, AND METAPLASIAS OF THE GALLBLADDER DATA YEARS 1999-2003

REVIEWING PHYSICIAN: HECTOR ZEPEDA, MD

DATA COLLECTORS: LOREN HUDSON, BA, CTR SANDRA JAQUEZ, CTR

PURPOSE:

This is a five-year study involving Del Sol Medical Center patients diagnosed with the above listed conditions of the gallbladder. The purpose of this study is to compare information from patients with metaplasia, dysplasia or carcinoma of the gallbladder and determine if there are statistical differences among them. The data collected will review the following areas:

ELIGIBILITY:

The study will compare cases from the data years 1999 through 2003, with report updates being made on an annual basis. The final report will be published in 2004. All patients diagnosed with carcinoma and dysplasia will be compared to an equal number of patients diagnosed with metaplasias of the gallbladder. A distinction between pseudopyloric and intestinal metaplasia will be made.

FINDINGS TO DATE:

TOTAL CASES: 34

CARCINOMAS = 11 DYSPLASIAS = 6 TOTALS = 17

METAPLASIAS / PSEUDOPYLORIC = 13 METAPLASIAS / INTESTINAL = 4 TOTALS = 17

AJCC TNM STAGE OF DISEASE AT DIAGNOSIS:

Carcinomas Only: Classification of disease at diagnosis for the 11 cases diagnosed as malignant is as follows:

Case # 1: T1, N0, M0 = Stage I

Case # 2: T4, N0, M0 = Stage IVA

Case # 3: T4, N0, M0 = Stage IVA

Case # 4: T3, N2, M0 = Stage IVB

Case # 5: T1a, N0, M0 = Stage I

Case # 6: Tis, N0, M0 = Stage 0

Case # 7: T1, N0, M0 = Stage I

Case # 8: T3, N1, M0 = Stage III

Case # 9: T4, N0, M0 = Stage IVA

Case # 10: T2, N0, M0 = Stage II

Case # 11: T1b, N0, M0 = Stage I

"Gallbladder cancers are staged primarily on the basis of surgical exploration or resection. Many in situ and early stage carcinomas are not recognized grossly. They are usually staged pathologically after histologic examination of the resected specimen..." (AJCC Cancer Staging Manual Fifth Edition, p. 98, Lippincott-Raven)

SUMMARY OF CURRENT DATA:

Similarities in comparing the study group's data for 1999 through 2001 are demonstrated in the following areas: All documented patient presentation at diagnosis showed all patients in both groups with an admitting complaint of abdominal pain. (One patient had no symptoms documented at admission.) Laboratory values indicate that the cases of carcinoma and the cases of pseudopyloric metaplasia evidenced similar numbers of normal and abnormal results (see lab review above.) Most patients were initially diagnosed through the use of gallbladder ultrasound. And, finally, all patients underwent surgery as an initial treatment. Although 1 patient's surgery was to a metastatic site. In initial presentation symptoms 47% of all patients present with nausea & vomiting. All of the 6 dysplasia cases presented with this symptom. Differences in the study's data to date include patient age distribution In initial presentation symptoms and medical history, one carcinoma and one dysplasia patient were jaundiced and there was no jaundice in the metaplasia group. Four patients in the carcinoma/dysplasia groups had a history of hypertension, but only two patients in the metaplasia group had the same diagnosis. (This could be contributed to the age differences between the two groups.) And while laboratory values were essentially equal in percentage of normal vs. abnormal, the abnormal elevations were definitely higher for the carcinoma/dysplasia-diagnosed patients for the following tests: Amylase, Lipase, ALT, Alkaline Phosphatase, and Total Bilirubin. (see lab review above.) Surgical treatment documentation indicates that all patients underwent cholecystectomy, four of the carcinoma/dysplasia patients, however, underwent an open cholecystectomy. One (1) of the metaplasia patients had an exploratory laparotomy that converted to open surgery. Further similarities and differences will be reviewed for the 2002 data during 2003. Final comparisons for all data years will be made at the study's completion in 2004.