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

Study Overview
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Brief Summary
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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).

Official Title
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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

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

Intervention / Treatment
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* Procedure: Falciform patch and fibrin glue application
* Procedure: standard pancreatic closure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patch and glue arm<br>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<br>* 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.<br>|
| Active Comparator: stapled /sutured pancreatic closure<br> | Procedure: standard pancreatic closure<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pancreatic fistula development post distal pancreatectomy |  | 30 days post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity- wound infection,delayed gastric emptying,abscess formation |  | 30 day | 
| Mortality |  | 30 day | 
| Surgical re-intervention/percutaneous interventions |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatectomy, fistula, fibrin glue, falciform patch, surgery, complications