OGT-assisted Overlap Esophagojejunostomy Versus Traditional Overlap Method

Summary

Abstract Background Our previous studies have shown OGT method significantly simplified overlap esophagojejunostomy with good short-term outcomes, and provided new perspectives for optimizing esophagojejunostomy. However, the safety and efficiency of OGT method still need evidence of randomized controlled trial.

Methods: This trial is a prospective, multicenter, randomized, controlled, open, and superiority trial. Three hundred and forty-four patients who met the inclusion criteria and did not accord with the exclusion criteria will be randomly divided into OGT group(n=172) and traditional group(n=172). The primary purpose of this study is to evaluate time of oesophagojejunostomy of OGT method compared with traditional method for Siewert III/II esophagogastric junction cancer and gastric cancer. The second purpose is to evaluate the success rate of inserting anvil fork into esophageal lumen at first attempt, attempts of inserting anvil fork into esophagus, early postoperative complications,recovery course and compare the postoperative hospital stay of the patients enrolled in this study.

Discussion: This trial is the first prospective randomized two-arm controlled study to determine the safety and efficiency of OGT method compared with traditional overlap method. Through this trial, we hope to show that experienced surgeons can safely perform OGT-assisted overlap esophagojejunostomy for Siewert III/II esophagogastric junction cancer and gastric cancer.

Conditions

• Gastric Cancer

Interventions

PROCEDURE

OGT group

In OGT group,the nasogastric tube was pulled out 3 cm from the oesophagal lumen to connect with the OGT. Meanwhile, the OGT was sleeved on anvil fork extracorporeally and the linear stapler was put into abdomen through trocar on the right side and then cartridge fork was inserted through jejunum opening towards the oral side of the lumen. Next, the anvil fork sleeved with OGT insert into the oesophageal mucosa canal by movement of the connection of fork -OGT -gastric tube.

PROCEDURE

Overlap group

In overlap group, the oesophagojejunostomy was performed as reported by Inaba et al.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University

  lead OTHER

Principal Investigators

• Jiang Yu, Ph.D · Nanfang Hospital, Southern Medical University

• Quan Wang, Ph.D · The First Hospital of Jilin University

• Kai Ye, Ph.D · Fujian Medical University 2nd Affiliated Hoapital

• Chuanfa Fang, Ph.D · Ganzhou City People Hospital

• Feirang Zhang, Ph.D · First Affiliated Hospital of Shantou University Medical College

• Wei Wang, Ph.D · The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

• Wenqing Hu, Ph.D · The People's Hospital of Changzhi

• Junjiang Wang, Ph.D · Guangdong Provincial People's Hospital

• Lei Lian, Ph.D · Sixth affiliated hospital of Sun Yat-sen University

• Jiaquan Zhu, Ph.D · First Hospital of China Medical University

• Yi Zhang, Ph.D · The Third Xiangya Hospital of Central South University

• Shuai Xiao, Ph.D · The First Affiliated Hospital of Nanhua University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-01

Primary Completion

2025-05-26

Completion

2025-12-30

Countries

• China

Study Locations