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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 30 day
Awards & highlights

Study 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 ~30 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pancreatic fistula development post distal pancreatectomy
Secondary outcome measures
Morbidity- wound infection,delayed gastric emptying,abscess formation
Mortality
Surgical re-intervention/percutaneous interventions

Side effects data

From 2014 Phase 4 trial • 256 Patients • NCT02034799
9%
Anemia
6%
Pyrexia
5%
Brain Oedema
2%
Lung Infection
1%
Glioma
1%
Postoperative Wound Infection
1%
Pneumonia
1%
Cerebral Ischaemia
1%
Deep Vein Thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bioseal Fibrin Sealant
Standard of Care (SoC)

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

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
444 Previous Clinical Trials
145,454 Total Patients Enrolled
1 Trials studying Pancreatic Fistula
2,900 Patients Enrolled for Pancreatic Fistula
Ernest L Rosato, M.D.Principal InvestigatorThomas Jefferson University

Frequently Asked Questions

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~11 spots leftby Apr 2025