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

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ClinicalTrials.gov Identifier: NCT02588066
Recruitment Status : Completed
First Posted : October 27, 2015
Last Update Posted : February 5, 2021
Sponsor:
Information provided by (Responsible Party):
Technische Universität Dresden

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.


Condition or disease Intervention/treatment Phase
Pancreatoduodenectomy Procedure: Ligamentum teres/falciform-plasty Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : November 2015
Actual Primary Completion Date : June 2020
Actual Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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



Primary Outcome Measures :
  1. Incidence of arrosion bleeding [ Time Frame: >24 hours after partial pancreatoduodenectomy ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02588066


Locations
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Germany
Department of Surgery, University Hospital Dresden
Dresden, Germany
Sponsors and Collaborators
Technische Universität Dresden
Investigators
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Principal Investigator: Thilo Welsch Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden, Germany
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT02588066    
Other Study ID Numbers: TW-002
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: February 5, 2021
Last Verified: February 2021
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes