OGT-assisted Overlap Esophagojejunostomy Versus Traditional Overlap Method (NCT05450835) | Clinical Trial Compass
RecruitingNot Applicable
OGT-assisted Overlap Esophagojejunostomy Versus Traditional Overlap Method
China344 participantsStarted 2022-09-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time of oesophagojejunostomy
Timeframe: 1 Days
Trial details
NCT IDNCT05450835
SponsorNanfang Hospital, Southern Medical University