Condition: Gastric Cancer · Sponsor: Nanfang Hospital, Southern Medical University
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.
This description comes directly from the study's public registry record.
Xinhua Chen, Ph.D · +8615626452302 · xinhuachen03@163.com
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| 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 |
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Source record: clinicaltrials.gov/study/NCT05450835