Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

PROCEDURE

OGT group

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.

PROCEDURE

Overlap group

In overlap group, the oesophagojejunostomy was performed as reported by Inaba et al.

Locations (12)

Fujian Medical University 2nd Affiliated Hoapital
Quanzhou, Fujian, China
Nanfang Hospital
Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Sixth affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Guangzhou, Guangdong, China
The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China
Ganzhou City People Hospital
Ganzhou, Guangxi, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hospital of Nanhua University
Hengyang, Hunan, China
The First Hospital Of Jilin University
Changchun, Jilin, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
The People's Hospital of Changzhi
Changzhi, Shanxi, China