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

NCT02588066 | Completed DMC

• 1 other identifier: TW-002
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatoduodenectomy

Outcome Measures

Primary Outcomes (1)

• Incidence of arrosion bleeding

  >24 hours after partial pancreatoduodenectomy

Study Arms (2)

Index test

EXPERIMENTAL

Ligamentum teres/falciform-plasty around the gastroduodenal artery stump during pancreatoduodenectomy

Procedure: Ligamentum teres/falciform-plasty

Reference test

NO INTERVENTION

No Ligamentum teres/falciform-plasty around the gastroduodenal artery stump during pancreatoduodenectomy

Interventions

Ligamentum teres/falciform-plasty PROCEDURE

Ligamentum teres/falciform-plasty around the gastroduodenal artery stump during pancreatoduodenectomy

Index test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (1)

Department of Surgery, University Hospital Dresden

Dresden, Germany

Location

Related Publications (2)

• 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.

  PMID: 34746958 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.

  PMID: 29650056 DERIVED

Study Officials

• Thilo Welsch

  Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: October 27, 2015
• Study Start: November 1, 2015
• Primary Completion: June 1, 2020
• Study Completion: July 1, 2020
• Last Updated: February 5, 2021

Record last verified: 2021-02

Locations

DE (1)