Clinical trial NCT02588066: Pancreatoduodenectomy With or Without Ligamentum Teres Wrap Around Gastroduodenal Artery Stump for Prevention of Pancreatic Hemorrhage
Official title: Pancreatoduodenectomy With or Without Prophylactic Ligamentum Teres Hepatic Wrap Around the Gastroduodenal Artery Stump for Prevention of Pancreatic Hemorrhage - Panda - Multicentric Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatoduodenectomy
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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
* 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

Primary outcomes:
measure: Incidence of arrosion bleeding
timeFrame: >24 hours after partial pancreatoduodenectomy
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Department of Surgery, University Hospital Dresden
Study officials:
affiliation: Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden, Germany
name: Thilo Welsch
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.