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: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | August 2008 |
| End Date: | December 2015 |
| Contact: | Ernest L. Rosato, M.D. |
| Email: | ernest.rosato@jefferson.edu |
| Phone: | 215-955-8666 |
A Prospective Randomized Comparison of Pancreatic Stump Closure Techniques Utilizing an Autologous Falciform Patch and Fibrin Glue Compared to Standard Closure Following Distal Pancreatectomy With or Without Splenectomy
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).
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).
Inclusion Criteria:
1. completion of a successful distal pancreatectomy with/without splenectomy
2. patient must have a pancreatic remnant in place
3. there must be a viable falciform ligament for creation of the autologous patch
Exclusion Criteria:
1. patients undergoing total pancreatectomy
2. patients undergoing distal pancreatectomy who have previously completed a right sided
resection of the pancreatic head, uncinate and neck
3. failure to sign informed consent
4. pregnant patients
5. patients in whom previous surgery has eliminated the falciform ligament, i.e.
previous liver resection
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