Gastric Venous Reconstruction After Total Pancreatectomy

NCT04850430 | Unknown

• 1 other identifier: S-173/2021
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Pancreas Cancer; Pancreatectomy

Keywords

Pancreatectomy; Gastric venous outflow reconstruction; Gastric venous congestion

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Gastric venous congestion following total pancreatectomy

EXPERIMENTAL

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

Interventions

Gastric venous reconstruction PROCEDURE

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.

Gastric venous congestion following total pancreatectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (2)

Surgery clinic

Heidelberg, 69493, Germany

Location

Professor Dr. med. Arianeb Mehrabi

Heidelberg, Germany

Location

Related Publications (1)

• 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.

  PMID: 34675020 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Arianeb Mehrabi, MD

CONTACT

004962215636223; arianeb.mehrabi@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professsor, Head of the Division of Liver Surgery and Visceral Transplantation

Model Details: 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.

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 20, 2021
• Study Start: February 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2025
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

DE (2)