OGT-assisted Overlap Esophagojejunostomy Versus Traditional Overlap Method
Recruiting
N/AInterventional Study
Gastric Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 75
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
344 (estimated)
Sponsor
Nanfang Hospital, Southern Medical University · Other
Who this trial is looking for
This trial is looking for adults with gastric cancer to compare a new surgical method with a traditional one. Participants will undergo a specific type of surgery for their condition.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 75 years old
I have been diagnosed with gastric adenocarcinoma
I am expected to live more than 1 year
My tumor is located in the gastroesophageal junction or stomach
I have not had upper abdominal surgery before
My performance status is 0 or 1
I have not had any preoperative radiotherapy
I have sufficient organ functions
You may not be able to join if
I am pregnant or breastfeeding
I have a body temperature of 38 °C or higher before surgery
I have severe mental disease
I have confirmed stage IV cancer during surgery
I have severe respiratory disease
I have severe liver or kidney dysfunction
I have unstable angina or a heart attack history in the last 6 months
I have had a stroke or brain bleeding in the last 6 months
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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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 …
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.
Trial Locations
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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, an…
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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