OGT-assisted Overlap Esophagojejunostomy Versus Traditional Overlap Method
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
Nanfang Hospital, Southern Medical University
344 participants
Sep 1, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria11
- 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 Criteria10
- 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.
Interventions
In OGT group,the nasogastric tube was pulled out 3 cm from the oesophagal lumen to connect with the OGT. Meanwhile, the OGT was sleeved on anvil fork extracorporeally and the linear stapler was put into abdomen through trocar on the right side and then cartridge fork was inserted through jejunum opening towards the oral side of the lumen. Next, the anvil fork sleeved with OGT insert into the oesophageal mucosa canal by movement of the connection of fork -OGT -gastric tube.
In overlap group, the oesophagojejunostomy was performed as reported by Inaba et al.
Locations(12)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05450835