Actively Recruiting
OGT-assisted Overlap Esophagojejunostomy Versus Traditional Overlap Method
Led by Nanfang Hospital, Southern Medical University · Updated on 2025-05-31
344
Participants Needed
12
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
OGT-assisted Overlap Esophagojejunostomy Versus Traditional Overlap Method
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-75 years
- Pathologically diagnosed with gastric adenocarcinoma
- Expected survival of more than 1 year
- Tumor located in gastroesophageal junction with esophageal involvement no more than 2 cm, or in the upper, upper to middle, or entire stomach
- Planned laparoscopic total gastrectomy with D2 lymphadenectomy
- No history of upper abdominal surgery except laparoscopic cholecystectomy
- Preoperative performance status (ECOG) of 0 or 1
- Preoperative ASA score of I to III
- No preoperative radiotherapy
- No metastasis found preoperatively or intraoperatively
- Sufficient organ function
- Provided written informed consent
You will not qualify if you...
- Women who are pregnant or breastfeeding
- Body temperature of 38°C or higher before surgery or systemic infectious disease requiring treatment
- Severe mental illness
- Confirmed stage IV cancer during surgery
- Severe respiratory disease
- Severe liver or kidney dysfunction
- Unstable angina or myocardial infarction within past 6 months
- History of cerebral infarction or hemorrhage within past 6 months
- Gastric cancer complications such as bleeding, perforation, or obstruction requiring emergency surgery
- Receiving hyperthermic intraperitoneal chemotherapy (HIPEC) after surgery
AI-Screening
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Trial Site Locations
Total: 12 locations
1
Fujian Medical University 2nd Affiliated Hoapital
Quanzhou, Fujian, China
Actively Recruiting
2
Nanfang Hospital
Guangzhou, Guangdong, China, 510515
Completed
3
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Actively Recruiting
4
Sixth affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Completed
5
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Guangzhou, Guangdong, China
Actively Recruiting
6
The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China
Actively Recruiting
7
Ganzhou City People Hospital
Ganzhou, Guangxi, China
Actively Recruiting
8
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013
Completed
9
The First Affiliated Hospital of Nanhua University
Hengyang, Hunan, China, 421001
Completed
10
The First Hospital Of Jilin University
Changchun, Jilin, China
Completed
11
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Completed
12
The People's Hospital of Changzhi
Changzhi, Shanxi, China
Completed
Research Team
X
Xinhua Chen, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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