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Gastric Venous Reconstruction After Total Pancreatectomy


2024-02-01


2024-08-01


2025-12-01


20

Study Overview

Gastric Venous Reconstruction After Total Pancreatectomy

Total pancreatoduodenectomy (TP) is the standard surgical approach for treatment of extended pancreas tumors. If the gastric coronary vein has to be sacrificed for oncologic or for technical reasons in total pancreatectomy with splenectomy, gastric venous congestion (GVC) may result because all major venous draining routes are terminated. In the sequelae of GVC, gastric venous infarction ultimately leads to gastric perforation with abdominal sepsis. To avoid gastric venous infarction, partial or even total gastrectomy is usually performed in the event of GVC after TP. However, this significantly impacts the patient's quality of life. Reconstruction of gastric venous outflow represents a technical approach to overcome GVC and to avoid gastric venous infarction making (partial) gastrectomy unnecessary. The current study aims to assess the role of gastric venous outflow reconstruction in GVC after TP to prevent (partial) gastrectomy.

N/A

  • Pancreas Cancer
  • Pancreatectomy
  • PROCEDURE: Gastric venous reconstruction
  • S-173/2021

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2021-04-14  

N/A  

2023-12-12  

2021-04-14  

N/A  

2023-12-13  

2021-04-20  

N/A  

2023-12  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Prevention


Allocation:
Na


Interventional Model:
Single Group


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Gastric venous congestion following total pancreatectomy

The gastric venous outflow will be reconstructed after TP. The patients will be assessed concerning gastric venous congestion and gastric ischemia intraoperatively before and after venous outflow reconstruction through onsite evaluation by the surgeon, en

PROCEDURE: Gastric venous reconstruction

  • Patients will be assigned to study after intraoperative evaluation of gastric venous drainage after coronary vein resection during TP, and the gastric venous outflow will be reconstructed after TP.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Incidence of gastric venous congestionGastric venous congestion after gastric venous reconstruction following total pancreatectomy30 days postoperative
Incidence of gastric ischemiaGastric ischemia after gastric venous reconstruction following total pancreatectomy30 days postoperative
Postpancreatectomy gastrectomy rateRate of gastrectomy after gastric venous reconstruction following total pancreatectomy30 days postoperative
Reoperation rateReoperation rate after gastric venous reconstruction following total pancreatectomy30 days postoperative
Morbidity rateComplications rate after gastric venous reconstruction following total pancreatectomy30 days postoperative
Mortality rateMortality rate after gastric venous reconstruction following total pancreatectomy30 days postoperative
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Arianeb Mehrabi, MD

Phone Number: 004962215636223

Email: arianeb.mehrabi@med.uni-heidelberg.de

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:

  • Age ≥ 18 years
  • Provide written informed consent
  • Elective total pancreatectomy for malignant or benign pancreatic lesions or chronic pancreatitis with splenectomy
  • Intraoperative ligation of coronary vein

  • Exclusion Criteria:

  • Gastric resection due to malignant infiltration
  • Non-reconstructable gastric venous drainage
  • Previous pancreas surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Mehrabi A, Loos M, Ramouz A, Dooghaie Moghadam A, Probst P, Nickel F, Schaible A, Mieth M, Hackert T, Buchler MW. Gastric venous reconstruction to reduce gastric venous congestion after total pancreatectomy: study protocol of a single-centre prospective non-randomised observational study (IDEAL Phase 2A) - GENDER study (Gastric vENous DrainagE Reconstruction). BMJ Open. 2021 Oct 21;11(10):e052745. doi: 10.1136/bmjopen-2021-052745.