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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04351321
• Other study ID #: CLASS08
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2020
• Est. completion date: August 2023

Study information

• Verified date: April 2020
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Zekuan Xu, M.D., Ph.D.
• Phone: +86-025-68306844
• Email: xuzekuan[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 560
• Est. completion date: August 2023
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Overall incidence of postoperative morbidity	Refers to the incidence of overall postoperative complications observed during follow-up period.	12 months