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Gastric Venous Reconstruction After Total Pancreatectomy

NCT ID: NCT04850430

Last Updated: 2023-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-12-01

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.

Detailed Description

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Conditions

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Pancreas Cancer Pancreatectomy

Keywords

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Pancreatectomy Gastric venous outflow reconstruction Gastric venous congestion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Gastric venous reconstruction

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Heidelberg

OTHER

Sponsor Role lead

Responsible Party

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Arianeb Mehrabi, MD

Professsor, Head of the Division of Liver Surgery and Visceral Transplantation

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Surgery clinic

Heidelberg, , Germany

Site Status

Professor Dr. med. Arianeb Mehrabi

Heidelberg, , Germany

Site Status

Countries

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Germany

Central Contacts

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Arianeb Mehrabi, MD

Role: CONTACT

Phone: 004962215636223

Email: [email protected]

Facility Contacts

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Arianeb Mehrabi

Role: primary

Arianeb Mehrabi

Role: primary

References

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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.

Reference Type DERIVED
PMID: 34675020 (View on PubMed)

Other Identifiers

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S-173/2021

Identifier Type: -

Identifier Source: org_study_id