OGT-assisted Overlap Esophagojejunostomy Versus Traditional Overlap Method

Recruiting now · Not applicable

Conditions studied: Gastric Cancer

In brief

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.

Key facts

Study ID: NCT05450835
Run by: Nanfang Hospital, Southern Medical University
People needed: 344
Starts: 2022-09-01
Expected to finish: 2025-12-30
Last updated by the study team: 2025-05-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Aged 18-75 years;
Primary lesion is pathologically diagnosed as gastric adenocarcinoma;
Expected to live more than 1 year;
Tumor located located in gastroesophageal junction (GEJ) involve esophagus no more than 2cm, or in the upper, upper to middle, or entire stomach, and intend to perform laparoscopic total gastrectomy with D2 lymphadenectomy
No history of upper abdominal surgery (except for laparoscopic cholecystectomy);
Preoperative performance status (ECOG, Eastern Cooperative Oncology Group) of 0 or 1;
Preoperative ASA (American Society of Anesthesiologists) scoring: I-III;
Without preoperative radiotherapy;
Did not found metastasis preoperatively and intraoperatively;
Sufficient organ functions;
Written informed consent.

You may not qualify if…

Women during pregnancy or breast-feeding;
Body temperature ≥ 38 °C before surgery or infectious disease with a systemic therapy indicated;
Severe mental disease;
Confirmed stage IV (AJCC 8th) during surgery
Severe respiratory disease;
Severe hepatic and renal dysfunction;
Unstable angina pectoris or history of myocardial infarction within 6 months;
History of cerebral infarction or cerebral hemorrhage within 6 months;
Gastric cancer complications (bleeding, perforation, obstruction) that requiring emergency surgery;
Performing hyperthermic intraperitoneal chemotherapy (HIPEC) after surgery.

Where it is running

Fujian Medical University 2nd Affiliated Hoapital — Quanzhou, Fujian, China (enrolling)
Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (enrolling)
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine — Guangzhou, Guangdong, China (enrolling)
The First Affiliated Hospital of Shantou University Medical College — Shantou, Guangdong, China (enrolling)
Ganzhou City People Hospital — Ganzhou, Guangxi, China (enrolling)
The First Hospital of China Medical University — Shenyang, Liaoning, China
The People's Hospital of Changzhi — Changzhi, Shanxi, China
The Third Xiangya Hospital of Central South University — Changsha, Hunan, China
Nanfang Hospital — Guangzhou, Guangdong, China
The First Affiliated Hospital of Nanhua University — Hengyang, Hunan, China
Sixth affiliated hospital of Sun Yat-sen University — Guangzhou, Guangdong, China
The First Hospital Of Jilin University — Changchun, Jilin, China

Full record on ClinicalTrials.gov

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