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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patch and glue arm | Experimental | 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 |
|
| stapled /sutured pancreatic closure | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Falciform patch and fibrin glue application | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pancreatic fistula development post distal pancreatectomy | 30 days post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity- wound infection,delayed gastric emptying,abscess formation | 30 day | |
| Mortality | 30 day | |
| Surgical re-intervention/percutaneous interventions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ernest L. Rosato, M.D. | Contact | 215-955-8666 | ernest.rosato@jefferson.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ernest L Rosato, M.D. | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Case Medical Center | Recruiting | Cleveland | Ohio | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22798186 | Derived | Carter TI, Fong ZV, Hyslop T, Lavu H, Tan WP, Hardacre J, Sauter PK, Kennedy EP, Yeo CJ, Rosato EL. A dual-institution randomized controlled trial of remnant closure after distal pancreatectomy: does the addition of a falciform patch and fibrin glue improve outcomes? J Gastrointest Surg. 2013 Jan;17(1):102-9. doi: 10.1007/s11605-012-1963-x. Epub 2012 Jul 14. |
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|
| standard pancreatic closure | Procedure | 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. |
|
| 30 days |
| Thomas Jefferson University | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
|
| ID | Term |
|---|---|
| D010185 | Pancreatic Fistula |
| D005402 | Fistula |
| ID | Term |
|---|---|
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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