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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Index test | Experimental | Ligamentum teres/falciform-plasty around the gastroduodenal artery stump during pancreatoduodenectomy |
|
| Reference test | No Intervention | No Ligamentum teres/falciform-plasty around the gastroduodenal artery stump during pancreatoduodenectomy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ligamentum teres/falciform-plasty | Procedure | Ligamentum teres/falciform-plasty around the gastroduodenal artery stump during pancreatoduodenectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of arrosion bleeding | >24 hours after partial pancreatoduodenectomy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thilo Welsch | Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, University Hospital Dresden | Dresden | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34746958 | Derived | Welsch T, Mussle B, Korn S, Sturm D, Bork U, Distler M, Grahlert X, Klimova A, Trebesius N, Kleespies A, Kees S, Beckert S, Reim D, Friess H, Elwerr M, Kleeff J, Popescu O, Schmitz-Winnenthal H, Janot-Matuschek M, Uhl W, Weber GF, Brunner M, Golcher H, Grutzmann R, Weitz J. Pancreatoduodenectomy with or without prophylactic falciform ligament wrap around the hepatic artery for prevention of postpancreatectomy haemorrhage: randomized clinical trial (PANDA trial). Br J Surg. 2021 Dec 17;109(1):37-45. doi: 10.1093/bjs/znab363. | |
| 29650056 |
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| Derived |
| Mussle B, Zuhlke L, Wierick A, Sturm D, Grahlert X, Distler M, Rahbari NN, Weitz J, Welsch T. Pancreatoduodenectomy with or without prophylactic falciform ligament wrap around the gastroduodenal artery stump for prevention of pancreatectomy hemorrhage. Trials. 2018 Apr 12;19(1):222. doi: 10.1186/s13063-018-2580-0. |