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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The First Hospital Of Jilin University
COMPLETED
Changchun
The Third Xiangya Hospital of Central South University
COMPLETED
Changsha
The People's Hospital of Changzhi
COMPLETED
Changzhi
Ganzhou City People Hospital
RECRUITING
Ganzhou
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Nanfang Hospital
COMPLETED
Guangzhou
Sixth affiliated hospital of Sun Yat-sen University
COMPLETED
Guangzhou
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
RECRUITING
Guangzhou
The First Affiliated Hospital of Nanhua University
COMPLETED
Hengyang
Fujian Medical University 2nd Affiliated Hoapital
RECRUITING
Quanzhou
The First Affiliated Hospital of Shantou University Medical College
RECRUITING
Shantou
The First Hospital of China Medical University
COMPLETED
Shenyang
Contact Information
Primary
Xinhua Chen, Ph.D
xinhuachen03@163.com
+8615626452302
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 344
Treatments
Experimental: Arm A
In OGT group,After the enterotomy was made, the nasogastric tube was pulled out 3 cm from the oesophagal lumen to connect with the OGT. Next, the anvil fork sleeved with OGT insert into the oesophageal mucosa canal by movement of the connection of fork -OGT -gastric tube. Then, the anaesthesiologist continued to pull back the nasogastric tube for 10 cm to ensure that the stapler would not clamp the nasogastric tube. After that, the surgeon began to fire the stapler to perform side-to-side esophagojejunostomy.
Active_comparator: Arm B
In overlap group, the oesophagojejunostomy was performed as reported by Inaba et al. After firing the stapler, two openings were converted into a single entry hole to create an end-to-side oesophagojejunostomy, and the entry hole was closed with full-thickness running suture using barbed sutures intracorporeally.
Related Therapeutic Areas
Sponsors
Leads: Nanfang Hospital, Southern Medical University

This content was sourced from clinicaltrials.gov