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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00889213
Other study ID # 08D.229
Secondary ID
Status Recruiting
Phase N/A
First received April 27, 2009
Last updated August 5, 2014
Start date August 2008
Est. completion date December 2015

Study information

Verified date August 2014
Source Thomas Jefferson University
Contact Ernest L. Rosato, M.D.
Phone 215-955-8666
Email ernest.rosato@jefferson.edu
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 190
Est. completion date December 2015
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Procedure:
Falciform patch and fibrin glue application
Following standard surgical exploration, the pancreatic gland will be mobilized appropriately to the level of transaction in the pancreatic neck, body or tail. The gland may be divided by stapling device, electrocautery or sharp division. Suture material will be at the discretion of the surgeon but may include absorbable or non-absorbable braided on mono-filament. Those patients randomized to autologous falciform patch will have the falciform membrane harvested. The falciform patch will be laid over the suture line of the resected pancreatic stump and secured to the pancreatic capsule utilizing #4-0 PDS suture placed at 12, 3, 6, and 9 o'clock positions. Fibrin glue (Vitagel) will be utilized to fill the potential space within this membranous capsule. Fibrin glue will be prepared as per standard instructions. Drains will be placed in the splenic bed and/or adjacent to the stump of the pancreas for postoperative fluid evacuation.
standard pancreatic closure
Following standard surgical exploration, the pancreatic gland will be mobilized appropriately to the level of transaction in the pancreatic neck, body or tail. The gland may be divided by stapling device, electrocautery or sharp division. Suture material will be at the discretion of the surgeon but may include absorbable or non-absorbable braided on mono-filament.

Locations

Country Name City State
United States University Hospitals Case Medical Center Cleveland Ohio
United States Thomas Jefferson University Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pancreatic fistula development post distal pancreatectomy 30 days post surgery No
Secondary Morbidity- wound infection,delayed gastric emptying,abscess formation 30 day No
Secondary Mortality 30 day No
Secondary Surgical re-intervention/percutaneous interventions 30 days No
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