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

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

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.

Study Overview

• Status: Completed
• Conditions: Pancreatoduodenectomy
• Intervention / Treatment: Procedure: Ligamentum teres/falciform-plasty

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 Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Dresden, Germany
    • Department of Surgery, University Hospital Dresden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Technische Universität Dresden
• Investigators: Principal Investigator: Thilo Welsch, Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden, Germany

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (ACTUAL): June 1, 2020
• Study Completion (ACTUAL): July 1, 2020

Study Registration Dates

• First Submitted: October 26, 2015
• First Submitted That Met QC Criteria: October 26, 2015
• First Posted (ESTIMATE): October 27, 2015

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: TW-002