Pancreatoduodenectomy With or Without Ligamentum Teres Wrap Around Gastroduodenal Artery Stump for Prevention of Pancreatic Hemorrhage
Study Details
Study Description
Brief Summary
To investigate, whether a prophylactic wrapping of the gastroduodenal artery stump with the ligamentum teres or falciform hepatic (embryological structures, covered with peritoneum that do not have relevant meaning for adults) can reduce the incidence of arrosion bleeding during surgery.
Thus a surgical technique is evaluated prospectively.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Pancreatoduodenectomy is a standard surgical procedure for resection of tumors of the pancreatic head and neck, and for selected patients with chronic pancreatitis. A postoperative pancreatic fistula (POPF) is a severe and frequent complication that may lead to a potentially letal arrosion hemorrhage from the stump of the gastroduodenal artery (GDA). Aim of the study is to evaluate the prophylactic wrapping of the GDA stump using the falciform hepatic ligament during the index operation. The null hypothesis is that prophylactic wrapping does not decrease the incidence of arrosion hemorrhage from the GDA stump. The study is designed as a randomized, single-blinded, controlled, multicenter trial.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Index test Ligamentum teres/falciform-plasty around the gastroduodenal artery stump during pancreatoduodenectomy |
Procedure: Ligamentum teres/falciform-plasty
Ligamentum teres/falciform-plasty around the gastroduodenal artery stump during pancreatoduodenectomy
|
| No Intervention: Reference test No Ligamentum teres/falciform-plasty around the gastroduodenal artery stump during pancreatoduodenectomy |
Outcome Measures
Primary Outcome Measures
- Incidence of arrosion bleeding [>24 hours after partial pancreatoduodenectomy]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Indication for elective open pancreatoduodenectomy (pylorus-preserving or classic) with pancreatojejunostomy for tumors, or cystic lesions of the pancreatic head, tumors of the distal bile duct, duodenum or for chronic pancreatitis
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american society of anesthesiologists classification I-III
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age ≥18 years
-
given informed consent
Exclusion Criteria:
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status post previous abdominal surgery with resection of the falciform ligament (e.g. hemihepatectomy)
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No reconstruction using a pancreatojejunostomy (e.g. pancreatogastrostomy)
-
simultaneous visceral arterial resection
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Surgery, University Hospital Dresden | Dresden | Germany |
Sponsors and Collaborators
- Technische Universität Dresden
Investigators
- Principal Investigator: Thilo Welsch, Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden, Germany
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TW-002