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

Primary Purpose

Pancreatoduodenectomy

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Ligamentum teres/falciform-plasty
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatoduodenectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Surgery, University Hospital Dresden

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Index test

Reference test

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incidence of arrosion bleeding

Secondary Outcome Measures

Full Information

First Posted
October 26, 2015
Last Updated
February 4, 2021
Sponsor
Technische Universität Dresden
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1. Study Identification

Unique Protocol Identification Number
NCT02588066
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
July 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technische Universität Dresden

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatoduodenectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Index test
Arm Type
Experimental
Arm Description
Ligamentum teres/falciform-plasty around the gastroduodenal artery stump during pancreatoduodenectomy
Arm Title
Reference test
Arm Type
No Intervention
Arm Description
No Ligamentum teres/falciform-plasty around the gastroduodenal artery stump during pancreatoduodenectomy
Intervention Type
Procedure
Intervention Name(s)
Ligamentum teres/falciform-plasty
Intervention Description
Ligamentum teres/falciform-plasty around the gastroduodenal artery stump during pancreatoduodenectomy
Primary Outcome Measure Information:
Title
Incidence of arrosion bleeding
Time Frame
>24 hours after partial pancreatoduodenectomy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thilo Welsch
Organizational Affiliation
Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, University Hospital Dresden
City
Dresden
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
34746958
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.
Results Reference
derived
PubMed Identifier
29650056
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.
Results Reference
derived

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

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