Comparing two methods for esophagojejunostomy in gastric cancer surgery

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

This study is testing a new surgical method for connecting the esophagus to the intestine in patients with certain types of stomach cancer to see if it is safer and more effective than the traditional method.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 344 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Nanfang Hospital, Southern Medical University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 12 sites (Quanzhou, Fujian and 11 other locations)
• Trial ID: NCT05450835 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with pathologically diagnosed gastric adenocarcinoma, expected to live more than one year, and suitable for laparoscopic total gastrectomy.

Not a fit: Patients with advanced stage IV gastric cancer or severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to safer surgical techniques with improved outcomes for patients undergoing surgery for gastric cancer.

How similar studies have performed: Previous studies have indicated promising outcomes for the OGT method, but this trial aims to provide definitive evidence through a randomized controlled approach.

Eligibility criteria

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 this trial is running

Quanzhou, Fujian and 11 other locations

• Fujian Medical University 2nd Affiliated Hoapital — Quanzhou, Fujian, China (Recruiting)
• Nanfang Hospital — Guangzhou, Guangdong, China (Completed)
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)
• Sixth affiliated hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Completed)
• 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)
• The Third Xiangya Hospital of Central South University — Changsha, Hunan, China (Completed)
• The First Affiliated Hospital of Nanhua University — Hengyang, Hunan, China (Completed)
• The First Hospital Of Jilin University — Changchun, Jilin, China (Completed)
• The First Hospital of China Medical University — Shenyang, Liaoning, China (Completed)
• The People's Hospital of Changzhi — Changzhi, Shanxi, China (Completed)

Study contacts

• Principal investigator: Jiang Yu, Ph.D — Nanfang Hospital, Southern Medical University
• Study coordinator: Xinhua Chen, Ph.D

Conditions Gastric Cancer; Gastric/gastroesophageal junction tumors; Laparoscopy total gastrectomy; Overlap esophagojejunostomy; OGT