Localized Gallbladder Cancer
Current Clinical Trials
Note: Some citations in the text of this section are followed by a level of
evidence. The PDQ editorial boards use a formal ranking system to help the
reader judge the strength of evidence linked to the reported results of a
therapeutic strategy. (Refer to the PDQ summary on Levels of Evidence for more
information.)
Localized gallbladder cancer is defined by the following TNM classification:
- Tis, T1a or b, selected T2, rare T3; N0; M0
When gallbladder cancer is previously unsuspected and is discovered in the
mucosa of the gallbladder at pathologic examination, it is curable in more than
80% of cases. Gallbladder cancer suspected before surgery because of
symptoms, however, usually penetrates the muscularis and serosa and is curable in fewer
than 5% of patients.
One study reported on patterns of lymph node spread from gallbladder
cancer and outcomes of patients with metastases to lymph nodes in 111
consecutive surgical patients in a single institution from 1981 to 1995.[1][Level
of evidence: 3iiiA] The standard surgical procedure was removal of the
gallbladder, a wedge resection of the liver, resection of the extrahepatic bile
duct, and resection of the regional (N1 and N2) lymph nodes. Kaplan-Meier
estimates of the 5-year survival for node negative tumors pathologically staged
as T2 to T4 were 42.5% ± 6.5% and for similar node positive tumors,
31% ± 6.2%.
Standard treatment options:
- Surgery: In previously unsuspected gallbladder cancer, discovered in the
surgical specimen following a routine gallbladder operation and confined to
mucosa or muscle layer (T1), the majority of patients are cured and require no
further surgical intervention.[2,3] Re-exploration to resect liver tissue near
the gallbladder bed or extended or formal hepatectomy and lymphadenectomy including N1 and N2 lymph node basins
may be associated with delayed recurrences or extended survival in patients with stage I or II
gallbladder cancer.[4,5] Apparently localized cancers that are suspected
before or during the operation can be surgically removed with a wedge of liver
and lymph nodes and lymphatic tissue in the hepatoduodenal ligament.
Long-term disease-free survival will occasionally be achieved. In jaundiced patients (stage III or stage
IV), there should be consideration of preoperative percutaneous transhepatic
biliary drainage for relief of biliary obstruction.
Implantation of the carcinoma at all port sites (including the camera site)
after laparoscopic removal of an unsuspected cancer is a problem. Even for
stage I cancers, the port sites must be excised completely.[6]
- External-beam radiation therapy (EBRT): The use of EBRT with or
without chemotherapy as a primary treatment has been reported in small groups
of patients to produce short-term control. Similar benefits have been reported
for radiation therapy with or without chemotherapy administered following
resection.[7,8]
Treatment options under clinical evaluation:
- Clinical trials are exploring ways of improving local control with radiation
therapy combined with radiosensitizer drugs. When possible, such patients are
appropriately considered candidates for these studies.
Current Clinical Trials
Check for U.S. clinical trials from NCI's PDQ Cancer Clinical Trials Registry that are now accepting patients with localized gallbladder cancer. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.
General information about clinical trials is also available from the NCI Web site.
References
-
Tsukada K, Kurosaki I, Uchida K, et al.: Lymph node spread from carcinoma of the gallbladder. Cancer 80 (4): 661-7, 1997.
[PUBMED Abstract]
-
Fong Y, Brennan MF, Turnbull A, et al.: Gallbladder cancer discovered during laparoscopic surgery. Potential for iatrogenic tumor dissemination. Arch Surg 128 (9): 1054-6, 1993.
[PUBMED Abstract]
-
Chijiiwa K, Tanaka M: Carcinoma of the gallbladder: an appraisal of surgical resection. Surgery 115 (6): 751-6, 1994.
[PUBMED Abstract]
-
Shirai Y, Yoshida K, Tsukada K, et al.: Inapparent carcinoma of the gallbladder. An appraisal of a radical second operation after simple cholecystectomy. Ann Surg 215 (4): 326-31, 1992.
[PUBMED Abstract]
-
Yamaguchi K, Chijiiwa K, Saiki S, et al.: Retrospective analysis of 70 operations for gallbladder carcinoma. Br J Surg 84 (2): 200-4, 1997.
[PUBMED Abstract]
-
Wibbenmeyer LA, Wade TP, Chen RC, et al.: Laparoscopic cholecystectomy can disseminate in situ carcinoma of the gallbladder. J Am Coll Surg 181 (6): 504-10, 1995.
[PUBMED Abstract]
-
Smoron GL: Radiation therapy of carcinoma of gallbladder and biliary tract. Cancer 40 (4): 1422-4, 1977.
[PUBMED Abstract]
-
Hejna M, Pruckmayer M, Raderer M: The role of chemotherapy and radiation in the management of biliary cancer: a review of the literature. Eur J Cancer 34 (7): 977-86, 1998.
[PUBMED Abstract]
Back to Top
< Previous Section | Next Section > |