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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04850430
Other study ID # S-173/2021
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 1, 2024
Est. completion date December 1, 2025

Study information

Verified date December 2023
Source University Hospital Heidelberg
Contact Arianeb Mehrabi, MD
Phone 004962215636223
Email arianeb.mehrabi@med.uni-heidelberg.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date December 1, 2025
Est. primary completion date August 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Germany Professor Dr. med. Arianeb Mehrabi Heidelberg
Germany Surgery clinic Heidelberg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of gastric venous congestion Gastric venous congestion after gastric venous reconstruction following total pancreatectomy 30 days postoperative
Primary Incidence of gastric ischemia Gastric ischemia after gastric venous reconstruction following total pancreatectomy 30 days postoperative
Primary Postpancreatectomy gastrectomy rate Rate of gastrectomy after gastric venous reconstruction following total pancreatectomy 30 days postoperative
Primary Reoperation rate Reoperation rate after gastric venous reconstruction following total pancreatectomy 30 days postoperative
Primary Morbidity rate Complications rate after gastric venous reconstruction following total pancreatectomy 30 days postoperative
Primary Mortality rate Mortality rate after gastric venous reconstruction following total pancreatectomy 30 days postoperative
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