Laparoscopic-assisted Distal Gastrectomy and Totally Laparoscopic Distal Gastrectomy for Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

A Multi-center Prospective Randomized Controlled Trial Comparing the Quality of Life Between Laparoscopic-assisted Distal Gastrectomy (LADG) and Totally Laparoscopic Distal Gastrectomy (TLDG) for Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05541783
• Other study ID #: LATDG
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: September 15, 2025

Study information

• Verified date: September 2022
• Source: Fudan University
• Contact: Dazhi Xu, PHD, MD
• Phone: 021-64175590
• Email: xudzh[@]shca.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is comparing the short-term quality of life between laparoscopy-assisted distal gastrectomy and totally laparoscopic distal gastrectomy for gastric cancer.

Description:

Although totally laparoscopic distal gastrectomy (TLDG) and laparoscopic-assisted distal gastrectomy (LADG) are both minimally invasive surgeries for gastric cancer with the same surgical treatment principles, in the former, all surgical processes are performed intracorporeally, while, in the latter, extracorporeal gastro-enteric anastomosis is achieved. Whether the procedural differences between TLDG and LADG affect quality of life （QOL）is still under debate.To evaluate how each laparoscopic surgery affect QOL of patients with gastric cancer, it is necessary to compare the postoperative QOL (scoring by questionnaire) between the patients undergoing TLDG and LADG through a multi-center randomized controlled trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 202
• Est. completion date: September 15, 2025
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• histologically proven gastric adenocarcinoma (by preoperative gastrofiberscopy)

• age between 20 and 80 years old

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• clinical stage I-III (T1-4aN0-2M0) according to the 8th edition of the Americal Joint Committee on Cancer System (Clinical stage was determined based on the finding of gastrofiberscopy and abdominal computed tomography)

• scheduled for laparoscopic distal gastrectomy with D2 lymphadenectomy, and possible for R0 surgery by this procedures (Lymphadenectomy is performed on the basis of the criteria of the Japanese

• written informed consent

• tumor size<5cm preoperatively

Exclusion Criteria:

• clinical stage T1-4N0-3M1 according to the 8th edition of the Americal Joint Committee on Cancer System

• history of chemotherapy, radiotherapy, immunotherapy or target therapy

• perigastric lymphnode=3cm

• received gastric surgery (i.e. gastrectomy or gastrojejunostomy)

• multiple primary tumors

• suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.

• patients need emergency operation with complication of gastric cancer

• adhesion due to the previous intraabdominal surgery

• need for combined organ resection due to aggression of gastric cancer of other disease,

• vulnerable people who cannot communicate or are pregnant (or planning to be pregnant)

• currently participating or participated in other clinical trials in the last 6 months

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• laparoscopy-assisted distal gastrectomy Group
LADG
• Totally laparoscopic distal gastrectomy
TLDG

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores on the physical function and pain symptom scales of EORTC QLQ-C30 questionnaire	Scores on the physical function and pain symptom scales of EORTC QLQ-C30 questionnaire at 1 months postoperative	1 months postoperative
Secondary	Scores on the other scales of EORTC QLQ-C30 questionnaire postoperative	Scores on the other scales of EORTC QLQ-C30 questionnaire at 1 months postoperative	1 months postoperative
Secondary	Scores on EORTC QLQ-C30 questionnaire	Scores on EORTC QLQ-C30 questionnaire at 7 day and 1 months postoperative	7 day and 1 months postoperative
Secondary	Usage of analgesics	Usage of analgesics postoperatively	1-7 day postoperative
Secondary	Length of stay	Length of stay	1 months postoperative
Secondary	Scores on the other scales of ST22 questionnaire postoperative	Scores on the other scales of ST22 questionnaire at 1 months postoperative	1 months postoperative
Secondary	Scores on ST22 questionnaire	Scores on ST22 questionnaire at 7 day and 1 months postoperative	7 day and 1 months postoperative