Safety and Feasibility of HIPEC for High-Risk Gallbladder Adenocarcinoma
Status:
Not yet recruiting
Trial end date:
2027-07-01
Target enrollment:
Participant gender:
Summary
Gallbladder adenocarcinoma is a devastating disease associated with a poor prognosis.
Gallbladder and other biliary cancers will be responsible for an estimated 11,980 new cases,
and 4,090 deaths in the US during 2020. The 5-year survival for all patients with gallbladder
cancer is 18%, however this plummets to 2% for patients with metastatic disease. Patients
with gallbladder cancer frequently develop peritoneal recurrence, particularly after
intra-operative bile spillage during cholecystectomy for incidentally discovered gallbladder
malignancy. Once developed, peritoneal metastases are difficult to treat and result in
significant morbidity and mortality. As a result, novel approaches that target peritoneal
metastases are needed for this disease. Prophylactic use of heated intraperitoneal
chemotherapy (HIPEC) has been explored or is under active investigation for numerous
gastrointestinal malignancies, including colon, gastric, and appendiceal cancers. HIPEC has
efficacy in gallbladder cancer patients with macroscopic peritoneal disease undergoing
cytoreductive surgery (CRS)/HIPEC and has been associated with a survival advantage in a
multi-institutional retrospective case series. Incidentally discovered gallbladder cancer is
treated with central hepatectomy and portal lymphadenectomy, therefore a prophylactic HIPEC
can be easily incorporated into the second operation performed as part of the standard of
care. In this early phase clinical trial, we will explore the safety and feasibility of
prophylactic HIPEC for gallbladder cancer in patients at high-risk of peritoneal recurrence.
The primary endpoint is to assess feasibility of the prophylactic heated intraperitoneal
chemotherapy (HIPEC) approach in gallbladder cancer. The primary endpoints include occurrence
of intra-operative complications, technical challenges, 90-day postoperative morbidity and
mortality, length of stay and readmission, which will be documented and compared with
historical controls after follow-up.