Anti-Adhesive Film for Tissue Adhesions

N/A

Waitlist Available

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

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

Must have

Patients ≥ 18 years of age.

Patients undergoing partial hepatectomy with high likelihood of needing repeat hepatectomy (e.g. those with colorectal liver metastasis and hepatocellular carcinoma)

Must not have

Patients who are found to have unresectable disease during surgery (additional hepatic lesions or extrahepatic metastatic disease precluding liver resection

Patients unable to provide informed consent.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-4 years from initial surgery, time of repeat surgery will vary from patient to patient

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate the effectiveness of using a hyaluronan and cellulose based antiadhesive film at the time of index hepatectomy in reducing perihepatic adhesions at the time of repeat hepatic surgery.

Who is the study for?

This trial is for adults over 18 who are having part of their liver removed and might need another surgery later, like those with colorectal liver metastasis or hepatocellular carcinoma. It's not for patients whose disease can't be operated on, those who can't agree to the study themselves, or people allergic to Seprafilm or its ingredients.

What is being tested?

The study tests a hyaluronan-cellulose film applied during initial liver surgery to see if it helps reduce tissue sticking together at follow-up surgeries. Participants will be randomly assigned to receive this anti-adhesive barrier or not.

What are the potential side effects?

While specific side effects aren't listed here, potential risks may include allergic reactions in individuals sensitive to the film's components and complications related to adhesion barriers.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am likely to need another liver surgery due to my liver cancer or metastasis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer cannot be removed with surgery due to its spread.

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I am unable to understand and give consent for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-4 years from initial surgery, time of repeat surgery will vary from patient to patient

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-4 years from initial surgery, time of repeat surgery will vary from patient to patient

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-4 years from initial surgery, time of repeat surgery will vary from patient to patient for reporting.