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NCT05430035 · ClinicalTrials.gov registry record · Early Phase 1
Safety and Feasibility of HIPEC for High-Risk Gallbladder Adenocarcinoma
A Early Phase 1 study of Gallbladder Adenocarcinoma, sponsored by West Virginia University.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT05430035: Recruiting Early Phase 1 study of Gallbladder Adenocarcinoma, sponsored by West Virginia University.
NCT05430035 is a Early Phase 1 study of Gallbladder Adenocarcinoma that is actively recruiting participants, run by West Virginia University. The registered enrollment target is 10 participants, below the 27-participant average among 3 other Gallbladder Adenocarcinoma trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05430035, a Early Phase 1 study of Gallbladder Adenocarcinoma, is actively recruiting participants, sponsored by West Virginia University.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study 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, the investigators 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 cont
Primary Outcome
Number of occurrences of intraoperative complications
Conditions Studied
Interventions
- DRUG HIPEC
Study Locations (1)
West Virginia
- West Virginia University Cancer Institute Mary Babb Randolph Cancer Center - Morgantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2022-06-23 |
| Est. Completion | 2029-07 |
| Phase | Early Phase 1 |
What NCT05430035 shows while recruiting
NCT05430035 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 27-participant average among 3 other Gallbladder Adenocarcinoma trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Gallbladder Adenocarcinoma appearing as the primary indexed condition, and to 1 intervention - of which HIPEC is the first listed.
NCT05430035 reports a single indexed study location in West Virginia.
Frequently Asked Questions
What is clinical trial NCT05430035 about?
NCT05430035 is a clinical study titled "Safety and Feasibility of HIPEC for High-Risk Gallbladder Adenocarcinoma". 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...
What is the current status of trial NCT05430035?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2022-06-23. Estimated completion is 2029-07.
What conditions does trial NCT05430035 study?
This clinical trial studies the following conditions: Gallbladder Adenocarcinoma.
What interventions are being tested in trial NCT05430035?
The interventions under investigation include: HIPEC (DRUG).
Who is sponsoring clinical trial NCT05430035?
This trial is sponsored by West Virginia University, which has 122 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05430035 being conducted?
This trial has 1 study location across West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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