Gastric Venous Reconstruction After Total Pancreatectomy

Study Overview
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Brief Summary
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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.

Official Title
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Gastric Venous Reconstruction to Reduce Gastric Venous Congestion After Total Pancreatectomy

Conditions
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Pancreas Cancer, Pancreatectomy

Intervention / Treatment
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* Procedure: Gastric venous reconstruction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Patients will be assigned to study after intraoperative evaluation of gastric venous drainage after coronary vein resection during TP. During surgery, onsite evaluation by the surgeon, endoscopic examination, indocyanine green, gastric venous drainage flowmetry, and spectral analysis will be performed. After surgery, patients will receive standard post-TP care and treatment. During hospitalization, endoscopic examination with indocyanine green will be performed on the first, third, and seventh postoperative day to evaluate gastric ischemia. Ischemia markers will be evaluated daily after surgery. After discharge, patients will be followed up for 30 days, during which mortality and morbidities will be recorded.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gastric venous congestion following total pancreatectomy<br>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. | Procedure: Gastric venous reconstruction<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatectomy, Gastric venous outflow reconstruction, Gastric venous congestion