Comparing two methods for esophagojejunostomy in gastric cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the safety and effectiveness of the OGT-assisted overlap esophagojejunostomy method compared to the traditional overlap method during laparoscopic total gastrectomy for patients with Siewert III/II esophagogastric junction cancer and gastric cancer. It is a multicenter, randomized, controlled, open-label trial involving 312 patients who will be divided into two groups: one receiving the OGT method and the other receiving the traditional method. The primary focus is on early operative morbidity and mortality, while secondary outcomes include the success rate of anvil fork insertion and postoperative recovery metrics.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fujian Medical University 2nd Affiliated Hoapital
  Quanzhou, Fujian, China Recruiting
• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Recruiting
• The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
  Guangzhou, Guangdong, China Recruiting
• The First Affiliated Hospital of Shantou University Medical College
  Shantou, Guangdong, China Recruiting
• Ganzhou City People Hospital
  Ganzhou, Guangxi, China Recruiting
• Nanfang Hospital
  Guangzhou, Guangdong, China Completed

Study contacts

• Principal investigator: Jiang Yu, Ph.D — Nanfang Hospital, Southern Medical University
• Study coordinator: Xinhua Chen, Ph.D
• Email: xinhuachen03@163.com
• Phone: +8615626452302

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.