NCT05450835Recruiting
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
Source: ClinicalTrials.gov · Last updated 31 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 344 (estimated)
- First submitted
- 1 Jul 2022
- Start date
- 1 Sept 2022
- Primary completion date
- 26 May 2025
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05450835
What you commit to
- Study type: Interventional
- Planned participants: 344
- From 1 Sept 2022 to the primary completion date, 26 May 2025
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Confirmed stage IV (AJCC 8th) during surgery
- Performing hyperthermic intraperitoneal chemotherapy (HIPEC) after surgery.
Other illness
- Body temperature ≥ 38 °C before surgery or infectious disease with a systemic therapy indicated;
- Severe mental disease;
- Severe respiratory disease;
- 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;
Other
- Women during pregnancy or breast-feeding;
- Severe hepatic and renal dysfunction;
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Completed |
| The Third Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Completed |
| The People's Hospital of Changzhi Coordinator of this site? Confirm its status | Changzhi | China | Completed |
| Ganzhou City People Hospital Coordinator of this site? Confirm its status | Ganzhou | China | Recruiting |
| Guangdong Provincial People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Sixth Affiliated Hospital of Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Completed |
| The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Nanfang Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Completed |
| The First Affiliated Hospital of Nanhua University Coordinator of this site? Confirm its status | Hengyang | China | Completed |
| Fujian Medical University 2nd Affiliated Hoapital Coordinator of this site? Confirm its status | Quanzhou | China | Recruiting |
| the First Affiliated Hospital of Shantou University Medical College Coordinator of this site? Confirm its status | Shantou | China | Recruiting |
| The First Hospital of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.