Gastric Venous Reconstruction After Total Pancreatectomy (GENDER)

Gastric Venous Reconstruction to Reduce Gastric Venous Congestion After Total Pancreatectomy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreas Cancer; Pancreatectomy
• Intervention / Treatment: Procedure: Gastric venous reconstruction

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arianeb Mehrabi, MD; Phone Number: 004962215636223; Email: arianeb.mehrabi@med.uni-heidelberg.de

Study Locations

• Germany
  • Heidelberg, Germany, 69493
    • Surgery clinic
    • Contact: Arianeb Mehrabi; Phone Number: 004962215636223; Email: arianeb.mehrabi@med.uni-heidelberg.de
  • Heidelberg, Germany
    • Professor Dr. med. Arianeb Mehrabi
    • Contact: Arianeb Mehrabi; Phone Number: 004962215636223; Email: arianeb.mehrabi@med.uni-heidelberg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Gastric venous congestion following total pancreatectomy; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg

Publications and helpful links

General Publications

• Mehrabi A, Loos M, Ramouz A, Dooghaie Moghadam A, Probst P, Nickel F, Schaible A, Mieth M, Hackert T, Buchler MW. Gastric venous reconstruction to reduce gastric venous congestion after total pancreatectomy: study protocol of a single-centre prospective non-randomised observational study (IDEAL Phase 2A) - GENDER study (Gastric vENous DrainagE Reconstruction). BMJ Open. 2021 Oct 21;11(10):e052745. doi: 10.1136/bmjopen-2021-052745.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 20, 2021

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Pancreatectomy; Gastric venous outflow reconstruction; Gastric venous congestion
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: S-173/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon reasonable request, the data generated by the current research that supports our future article, would be made available as soon as possible, wherever legally and ethically possible.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No