2024-02-01
2024-08-01
2025-12-01
20
NCT04850430
University Hospital Heidelberg
University Hospital Heidelberg
INTERVENTIONAL
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
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 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Prevention
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
Participant Group/Arm | Intervention/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
|
Primary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Incidence of gastric venous congestion | Gastric venous congestion after gastric venous reconstruction following total pancreatectomy | 30 days postoperative |
Incidence of gastric ischemia | Gastric ischemia after gastric venous reconstruction following total pancreatectomy | 30 days postoperative |
Postpancreatectomy gastrectomy rate | Rate of gastrectomy after gastric venous reconstruction following total pancreatectomy | 30 days postoperative |
Reoperation rate | Reoperation rate after gastric venous reconstruction following total pancreatectomy | 30 days postoperative |
Morbidity rate | Complications rate after gastric venous reconstruction following total pancreatectomy | 30 days postoperative |
Mortality rate | Mortality rate after gastric venous reconstruction following total pancreatectomy | 30 days postoperative |
Secondary Outcome Measures | Measure Description | Time Frame |
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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 |
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:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.