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Procedure

HIPEC for Gallbladder Cancer

Phase < 1

Recruiting

Led By Brian Boone, MD

Research Sponsored by West Virginia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must have normal organ and marrow function as defined below:

Eligible TNM staging includes >T1b meeting above criteria, any N, and M0

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing whether a prophylactic heated intraperitoneal chemotherapy (HIPEC) approach is safe and feasible in gallbladder cancer patients at high-risk of peritoneal recurrence.

Who is the study for?

This trial is for patients with high-risk gallbladder adenocarcinoma who've had bile spillage during surgery or have advanced tumors. They must have certain blood cell counts, normal organ function, no prior systemic therapy for this cancer, and not be pregnant or breastfeeding. Patients should be physically able to undergo additional surgery and agree to the study's terms.Check my eligibility

What is being tested?

The trial tests the safety of HIPEC (heated chemotherapy delivered directly into the abdomen) as a preventive treatment against peritoneal recurrence in gallbladder cancer after surgery. It measures complications, recovery time, and any postoperative issues compared to past data.See study design

What are the potential side effects?

While specific side effects are not listed here, HIPEC can generally cause abdominal pain, risk of infection due to low blood cell counts from chemotherapy drugs used in the procedure, fatigue, nausea or vomiting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My organ and bone marrow functions are normal.

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My cancer is larger than 0.5cm but has not spread to distant organs.

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I have gallbladder cancer that has spread, leaked bile during surgery, or is poorly differentiated.

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I can take care of myself but might not be able to do heavy physical work.

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I am a candidate for liver surgery, including gallbladder removal if needed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Length of Stay

Occurrences of Postoperative Morbidity and Mortality

Occurrences of intraoperative complications

+1 more

Secondary outcome measures

Disease Free Survival

Peritoneal Metastases

Trial Design

1Treatment groups

Experimental Treatment

Group I: HIPECExperimental Treatment1 Intervention

Prophylactic Heated Intra-peritoneal Chemotherapy (HIPEC) 30 mg of mitomycin C (MMC) over the first 60 minutes followed by 10 mg over an additional 30 minutes. Perfusate will be heated to obtain a tissue temperature of 42°.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

HIPEC

2014

Completed Phase 3

~230

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

West Virginia UniversityLead Sponsor

176 Previous Clinical Trials

60,218 Total Patients Enrolled

Brian Boone, MDPrincipal InvestigatorWVU Cancer Institute

1 Previous Clinical Trials

40 Total Patients Enrolled

Media Library

HIPEC (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05430035 — Phase < 1

Gallbladder Cancer Research Study Groups: HIPEC

Gallbladder Cancer Clinical Trial 2023: HIPEC Highlights & Side Effects. Trial Name: NCT05430035 — Phase < 1

HIPEC (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05430035 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings available for participants in this trial?

"Clinicaltrials.gov reports that this patient recruitment is still open, with the study first being posted on June 23rd 2022 and last updated October 24th 2022."

Answered by AI

What is the cap on participants for this experiment?

"Affirmative. Clinicaltrials.gov has detailed that this research is actively seeking participants and initially posted on June 23rd 2022, with an update occurring October 24th of the same year. The recruitment effort will be targeting 10 individuals across a single medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Feasibility of HIPEC for High-Risk Gallbladder Adenocarcinoma

Brian Boone, MD, FACS 2022. "Safety and Feasibility of HIPEC for High-Risk Gallbladder Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05430035.

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