Gastric Venous Reconstruction After Total Pancreatectomy

Not Applicable

Not yet recruiting

• Conditions: Pancreas Cancer; Pancreatectomy
• Interventions: Procedure: Gastric venous reconstruction

• Registration Number: NCT04850430
• Lead Sponsor: University Hospital Heidelberg

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-14
• Study First Submitted QC: 2021-04-14
• Study First Posted: 2021-04-20
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-13
• Study Start: 2024-02-01
• Primary Completion: 2024-08-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gastric venous congestion following total pancreatectomy	Gastric venous reconstruction	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, endoscopic examination, indocyanine green, gastric venous drainage flowmetry, and spectral imaging.

Primary Outcome Measures

Name	Time	Method
Incidence of gastric venous congestion	30 days postoperative	Gastric venous congestion after gastric venous reconstruction following total pancreatectomy
Reoperation rate	30 days postoperative	Reoperation rate after gastric venous reconstruction following total pancreatectomy
Morbidity rate	30 days postoperative	Complications rate after gastric venous reconstruction following total pancreatectomy
Incidence of gastric ischemia	30 days postoperative	Gastric ischemia after gastric venous reconstruction following total pancreatectomy
Postpancreatectomy gastrectomy rate	30 days postoperative	Rate of gastrectomy after gastric venous reconstruction following total pancreatectomy
Mortality rate	30 days postoperative	Mortality rate after gastric venous reconstruction following total pancreatectomy

Trial Locations

Locations (2)

Surgery clinic; 🇩🇪 Heidelberg, Germany

Professor Dr. med. Arianeb Mehrabi; 🇩🇪 Heidelberg, Germany