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
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Thomas Jefferson University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Thomas Jefferson University
Information provided by:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00889213
First received: April 27, 2009
Last updated: February 25, 2010
Last verified: February 2010
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Pancreatic Fistula Distal Pancreatectomy Complications Falciform Patch Pancreatic Closure Fibrin Glue Pancreatic Closure |
Procedure: Falciform patch and fibrin glue application Procedure: standard pancreatic closure |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Thomas Jefferson University:
Primary Outcome Measures:
- Pancreatic fistula development post distal pancreatectomy [ Time Frame: 30 days post surgery ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Morbidity- wound infection,delayed gastric emptying,abscess formation [ Time Frame: 30 day ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: 30 day ] [ Designated as safety issue: No ]
- Surgical re-intervention/percutaneous interventions [ Time Frame: 30 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 190 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Patch and glue arm
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
|
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.
|
| Active Comparator: stapled /sutured pancreatic closure |
Procedure: 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00889213
Contacts
| Contact: Ernest L. Rosato, M.D. | 215-955-8666 | ernest.rosato@jefferson.edu |
Locations
| United States, Ohio | |
| University Hospitals Case Medical Center | Recruiting |
| Cleveland, Ohio, United States | |
| Contact: Jeffrey M Hardacre, MD 216-844-7047 jeffrey.hardacre@UHospitals.org | |
| Contact: Bridget Ermlich, RN (216) 844-3602 bridget.ermlich@UHospitals.org | |
| Principal Investigator: Jeffrey M Hardacre, MD | |
| United States, Pennsylvania | |
| Thomas Jefferson University | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Ernest L Rosato, M.D. 215-955-8666 ernest.rosato@jefferson.edu | |
| Principal Investigator: Ernest L Rosato, M.D. | |
| Sub-Investigator: Charles J Yeo, M.D. | |
| Sub-Investigator: Adam Berger, M.D. | |
| Sub-Investigator: Karen Chojnacki, M.D. | |
| Sub-Investigator: Eugene Kennedy, M.D. | |
| Sub-Investigator: Francis E Rosato, M.D. | |
| Sub-Investigator: Bernadette Profetta, M.D. | |
Sponsors and Collaborators
Thomas Jefferson University
Investigators
| Principal Investigator: | Ernest L Rosato, M.D. | Thomas Jefferson University |
More Information
No publications provided by Thomas Jefferson University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ernest L. Rosato M.D., Department of Surgery Thomas Jefferson University |
| ClinicalTrials.gov Identifier: | NCT00889213 History of Changes |
| Other Study ID Numbers: | 08D.229 |
| Study First Received: | April 27, 2009 |
| Last Updated: | February 25, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Thomas Jefferson University:
|
pancreatectomy fistula fibrin glue |
falciform patch surgery complications |
Additional relevant MeSH terms:
|
Fistula Pancreatic Fistula Pathological Conditions, Anatomical Digestive System Fistula Digestive System Diseases Pancreatic Diseases Fibrin Tissue Adhesive |
Pancrelipase Hemostatics Coagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 19, 2013