Pancreatoduodenectomy With or Without Ligamentum Teres Wrap Around Gastroduodenal Artery Stump for Prevention of Pancreatic Hemorrhage

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pancreatoduodenectomy With or Without Prophylactic Ligamentum Teres Hepatic Wrap Around the Gastroduodenal Artery Stump for Prevention of Pancreatic Hemorrhage - Panda - Multicentric Randomized Controlled Trial

Conditions
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Pancreatoduodenectomy

Intervention / Treatment
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* Procedure: Ligamentum teres/falciform-plasty


Participation Criteria
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Eligibility Criteria
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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 american society of anesthesiologists classification I-III age ≥18 years given informed consent Exclusion Criteria: status post previous abdominal surgery with resection of the falciform ligament (e.g. hemihepatectomy) No reconstruction using a pancreatojejunostomy (e.g. pancreatogastrostomy) simultaneous visceral arterial 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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Index test<br>Ligamentum teres/falciform-plasty around the gastroduodenal artery stump during pancreatoduodenectomy | Procedure: Ligamentum teres/falciform-plasty<br>* Ligamentum teres/falciform-plasty around the gastroduodenal artery stump during pancreatoduodenectomy<br>|
| No Intervention: Reference test<br>No Ligamentum teres/falciform-plasty around the gastroduodenal artery stump during pancreatoduodenectomy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of arrosion bleeding |  | >24 hours after partial pancreatoduodenectomy |