Gastric Venous Reconstruction After Total Pancreatectomy

Pancreas Cancer Clinical Trial

— GENDER  

Official title:

Gastric Venous Reconstruction to Reduce Gastric Venous Congestion After Total Pancreatectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04850430
• Other study ID #: S-173/2021
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatectomy
• Pancreatic Neoplasms

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