Distal Pancreatectomy Complications, Falciform Patch Pancreatic Closure, Fibrin Glue Pancreatic Closure, Pancreatic Fistula
Conditions
Keywords
pancreatectomy, fistula, fibrin glue, falciform patch, surgery, complications
Brief 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).
Interventions
PROCEDUREFalciform 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.
PROCEDUREstandard 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.
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pancreatic fistula development post distal pancreatectomy | 30 days post surgery |
Secondary
| Measure | Time frame |
|---|---|
| Morbidity- wound infection,delayed gastric emptying,abscess formation | 30 day |
| Mortality | 30 day |
| Surgical re-intervention/percutaneous interventions | 30 days |
Countries
United States
Contacts
Primary ContactErnest L. Rosato, M.D.
Outcome results
None listed