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RECRUITING
NCT05450835
NA

OGT-assisted Overlap Esophagojejunostomy Versus Traditional Overlap Method

Sponsor: Nanfang Hospital, Southern Medical University

View on ClinicalTrials.gov

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.

Official title: Comparison Of Short-term Outcomes Between OGT-assisted Overlap Esophagojejunostomy And Traditional Overlap Method In Patients With Siewert III/II Esophagogastric Junction Cancer Or Gastric Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

344

Start Date

2022-09-01

Completion Date

2025-12-30

Last Updated

2025-05-31

Healthy Volunteers

No

Conditions

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.

Locations (12)

Fujian Medical University 2nd Affiliated Hoapital

Quanzhou, Fujian, China

Nanfang Hospital

Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Sixth affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Guangzhou, Guangdong, China

The First Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, China

Ganzhou City People Hospital

Ganzhou, Guangxi, China

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

The First Affiliated Hospital of Nanhua University

Hengyang, Hunan, China

The First Hospital Of Jilin University

Changchun, Jilin, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

The People's Hospital of Changzhi

Changzhi, Shanxi, China