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Procedure

Patch and glue arm for Pancreatic Fistula

N/A
Waitlist Available
Led By Ernest L Rosato, M.D.
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

The purpose of this trial is to determine whether the use of an autologous falciform ligament patch combined with fibrin glue will reduce the rate of pancreatic fistula in patients completing distal pancreatectomy. The hypothesis for the current trial is: Autologous falciform patch closure with fibrin glue will result in a 50% decrease in fistula formation postoperatively. The primary end point will be the development of pancreatic fistula using the ISGPF definition of pancreatic fistula1. (Drain output of any measurable volume of fluid on or after postop day #3 with an amylase content greater than three times serum amylase). Secondary end points will include length of postoperative hospital stay, percutaneous intervention rates, re-operation rates, morbidity to include delayed gastric emptying, wound infection, intraabdominal abscess, postoperative hemorrhage and 30-day mortality.(Bassi C, Dervenis C, Butturini G, et al. Postoperative pancreatic fistula: An international study group (ISGPF) definition. The Journal of Surgery, 2005;138:8-13).

Eligible Conditions
  • Pancreatic Fistula
  • Distal Pancreatectomy Complications
  • Falciform Patch Pancreatic Closure
  • Fibrin Glue Pancreatic Closure

Timeline

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Patch and glue armExperimental Treatment1 Intervention
Randomized patients to the patch and glue arm will undergo placement of a falciform ligament tissue patch and fibrin glue to the resection margin of the remnant pancreas following distal pancreatectomy
Group II: stapled /sutured pancreatic closureActive Control1 Intervention

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Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
464 Previous Clinical Trials
175,559 Total Patients Enrolled
1 Trials studying Pancreatic Fistula
2,900 Patients Enrolled for Pancreatic Fistula
Ernest L Rosato, M.D.Principal InvestigatorThomas Jefferson University
~11 spots leftby Dec 2025