RecruitingNot ApplicableNCT05450835

OGT-assisted Overlap Esophagojejunostomy Versus Traditional Overlap Method

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


Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

344 participants

Start Date

Sep 1, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares two surgical techniques for reconnecting the food pipe (esophagus) to the small intestine during stomach removal surgery (gastrectomy). Both methods use a device called an OGT, but the study tests whether a new assisted approach gives better results than the traditional overlap method. **You may be eligible if...** - You are an adult scheduled for total or partial stomach removal surgery (typically for stomach cancer) - Your surgeon determines that either technique is appropriate for your anatomy - You are able to provide informed consent **You may NOT be eligible if...** - You have conditions that make one surgical approach unsafe - You have had previous surgeries that would complicate the procedure - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREOGT 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.

PROCEDUREOverlap 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

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NCT05450835


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