Surgical TreAtment for Obesity Related Disease and Onco-Metabolic Surgery

Summary

This is a prospective, multi-center, randomized controlled trial to compare Billroth II reconstruction versus conventional Roux-en-Y reconstruction versus long limb Roux-en-Y reconstruction for glycemic control in patients with concurrent type 2 diabetes and gastric cancer.

Conditions

• Gastric Cancer
• Diabetes Mellitus, Type 2

Interventions

PROCEDURE

Long limb Roux-en-Y reconstruction after subtotal gastrectomy

The jejunum will be divided approximately 150 cm distal to the ligament of Treitz (Length of biliopancreatic limb). The gastrojejunostomy will be performed by end-to-end anastomosis and an anastomosis of the proximal end of the jejunum to the distal jejunum will be created approximately 50 cm distal from the gastrojejunal anastomosis (Length of Roux-en-Y limb).

PROCEDURE

Conventional Roux-en-Y reconstruction after subtotal gastrectomy

The jejunum will be divided approximately 20 cm distal to the ligament of Treitz (Length of biliopancreatic limb). The gastrojejunostomy will be performed by end-to-end anastomosis and an anastomosis of the proximal end of the jejunum to the distal jejunum will be created approximately 30-45 cm distal from the gastrojejunal anastomosis (Length of Roux-en-Y limb).

PROCEDURE

Billroth II reconstruction after subtotal gastrectomy

The duodenum will be transected approximately 2 cm distal to the pylorus and anastomosis will be performed between the gastric remnant and a loop of jejunum chosen approximately 20 cm distal to the ligament of Treitz (Length of afferent loop)

Sponsors & Collaborators

• Guangdong Provincial People's Hospital

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• Guangdong Provincial Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Korea University Ansan Hospital

  collaborator OTHER

• Korea University Anam Hospital

  lead OTHER

Principal Investigators

• Sungsoo Park, MD, PhD · Korea University Anam Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

69 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-01

Primary Completion

2023-11-30

Completion

2023-12-31

Countries

• South Korea

Study Locations