An Evaluation of a New Technique Utilizing a Biologic Glue and Tissue Patch to Seal the Cut Edge of the Pancreas Following Removal of the Tail of the Pancreas

Status unconfirmed · Not applicable

Conditions studied: Pancreatic Fistula, Distal Pancreatectomy Complications, Falciform Patch Pancreatic Closure, Fibrin Glue Pancreatic Closure

In brief

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).

Key facts

Study ID

NCT00889213

Run by

Thomas Jefferson University

People needed

190

Starts

2008-08-01

Expected to finish

2015-12-01

Last updated by the study team

2014-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• completion of a successful distal pancreatectomy with/without splenectomy
• patient must have a pancreatic remnant in place
• there must be a viable falciform ligament for creation of the autologous patch

You may not qualify if…

• patients undergoing total pancreatectomy
• patients undergoing distal pancreatectomy who have previously completed a right sided resection of the pancreatic head, uncinate and neck
• failure to sign informed consent
• pregnant patients
• patients in whom previous surgery has eliminated the falciform ligament, i.e. previous liver resection

Where it is running

• University Hospitals Case Medical Center — Cleveland, Ohio, United States (enrolling)
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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