The Safety of Totally Laparoscopic Versus Laparoscopy-Assisted Total Gastrectomy.

A Multicenter, Randomized, Controlled Clinical Trial of the Safety of Totally Laparoscopic Versus Laparoscopy-Assisted Total Gastrectomy for Gastric Cancer.

To compare the short-term surgical safety and postoperative quality of life of totally laparoscopic versus laparoscopy-assisted total gastrectomy and to evaluate the superiority of totally laparoscopic total gastrectomy.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Procedure: Totally Laparoscopic Total Gastrectomy; Procedure: Laparoscopy-Assisted Total Gastrectomy

• Study Type: Interventional
• Enrollment (Anticipated): 560
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zekuan Xu, M.D., Ph.D.; Phone Number: +86-025-68306844; Email: xuzekuan@njmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Aged 18-75 years；
2. Primary lesion is diagnosed with endometrial biopsy as adenocarcinoma of the stomach or esophagogastric junction, including: papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), mixed adenocarcinoma, etc.；
3. Clinical stage cT1N0M0, cT1N1M0, cT2N0M0；
4. The gastric primary lesion is located in the body or fundus of stomach or the esophagogastric junction. It is expected that total gastrectomy with D1+/D2 lymph node dissection achieves R0 resection (multiple primary cancers are also applicable)；
5. BMI(Body Mass Index)<30 kg/m2；
6. No history of upper abdominal surgery (except for laparoscopic cholecystectomy)；
7. No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.；
8. Preoperative ECOG (Eastern Cooperative Oncology Group) performance status score 0 or 1；
9. Preoperative ASA (American Society of Anesthesiologists) scoring I-III；
10. Sufficient vital organ functions；
11. Signed informed consent.

Exclusion Criteria:

1. Preoperative examination indicates disease stage cStage II or above；
2. Women during pregnancy or lactation；
3. Suffer from other malignant tumors within 5 years；
4. Preoperative body temperature ≥ 38°C or complicated with infectious diseases requiring systemic treatment；
5. Severe mental illness；
6. Severe respiratory disease；
7. Severe liver and kidney dysfunction；
8. History of unstable angina or myocardial infarction within 6 months；
9. History of cerebral infarction or cerebral hemorrhage within 6 months；
10. Continuous application of glucocorticoid within 1 month (except for topical application)；
11. Accompanied by gastric cancer complications (bleeding, perforation, obstruction, etc.) ；
12. The patient has participated in or is participating in other clinical studies (within 6 months).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Totally Laparoscopic Total Gastrectomy; Totally laparoscopic total gastrectomy will be performed for the treatment of patients assigned to this group.	Procedure: Totally Laparoscopic Total Gastrectomy; Totally laparoscopic total gastrectomy will be performed in patients with gastric or esophagogastric junction adenocarcinoma of preoperative clinical stage I (T1N0M0, T1N1M0, T2N0M0) with D1+/D2 lymph node dissection.
Active Comparator: Laparoscopy-Assisted Total Gastrectomy; Laparoscopy-assisted total gastrectomy will be performed for the treatment of patients assigned to this group.	Procedure: Laparoscopy-Assisted Total Gastrectomy; Laparoscopy-Assisted Total Gastrectomy will be performed in patients with gastric or esophagogastric junction adenocarcinoma of preoperative clinical stage I (T1N0M0, T1N1M0, T2N0M0) with D1+/D2 lymph node dissection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of postoperative morbidity	Refers to the incidence of early postoperative complications. The early postoperative complications are defined as the events observed within postoperative 30 days.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life score	Quality of life scores of the patients are evaluated based on EORTC C30 questionnaire at the 3rd, 6th and 12th months after operation.	3, 6 and 12 months
Quality of life score	Quality of life scores of the patients are evaluated based on STO22 questionnaire at the 3rd, 6th and 12th months after operation.	3, 6 and 12 months
Overall incidence of postoperative morbidity	Refers to the incidence of overall postoperative complications observed during follow-up period.	12 months

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: April 13, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (Actual): April 17, 2020

Study Record Updates

• Last Update Posted (Actual): April 17, 2020
• Last Update Submitted That Met QC Criteria: April 16, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: CLASS08

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No