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OGT-assisted Overlap Esophagojejunostomy Versus Traditional Overlap Method

RecruitingNAAges 18 Years - 75 YearsAllNanfang Hospital, Southern Medical University
NCT05450835 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 l

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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What it tests

  • OGT group
  • Overlap group
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Where

12 sites
Fujian Medical University 2nd Affiliated Hoapital
Quanzhou, China
Nanfang Hospital
Guangzhou, China
Guangdong Provincial People's Hospital
Guangzhou, China
Sixth affiliated hospital of Sun Yat-sen University
Guangzhou, China
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Guangzhou, China
The First Affiliated Hospital of Shantou University Medical College
Shantou, China
Ganzhou City People Hospital
Ganzhou, China
The Third Xiangya Hospital of Central South University
Changsha, China

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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