Gastric Venous Reconstruction After Total Pancreatectomy (GENDER)

University Hospital Heidelberg

Status: Not yet enrolling

Conditions: Pancreas Cancer; Pancreatectomy

Treatments: Procedure: Gastric venous reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT04850430

S-173/2021

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Gastric venous congestion following total pancreatectomy

Experimental group

Description:

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.

Treatment:

Procedure: Gastric venous reconstruction