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

NCT05541783 | Completed DMC

• 1 other identifier: LATDG
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Cancer

Keywords

Gastric cancer，Laparoscopic distal gastrectomy

Outcome Measures

Primary Outcomes (1)

• 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 30 days postoperatively

  30 days postoperatively

Secondary Outcomes (3)

• Scores on the other scales of EORTC QLQ-C30 questionnaire postoperatively

  30 days postoperatively

• Scores on EORTC QLQ-C30 questionnaire

  7 days and 90 days postoperatively

• Scores on the scales of EORTC QLQ-STO22 questionnaire postoperatively

  7，30 and 90 days postoperatively

Study Arms (2)

Laparoscopy-assisted distal gastrectomy

ACTIVE COMPARATOR

The patients who are assigned to LADG group undergo extracorporeal anasto- mosis for gastrointestinal reconstruction.

Procedure: laparoscopy-assisted distal gastrectomy Group

Totally laparoscopic distal gastrectomy

EXPERIMENTAL

The patients who are allocated to TLDG group undergo intracorporeal anastomosis for the recovery of gastrointes- tinal continuity after gastrectomy.

Procedure: Totally laparoscopic distal gastrectomy

Interventions

laparoscopy-assisted distal gastrectomy Group PROCEDURE

LADG

Laparoscopy-assisted distal gastrectomy

Totally laparoscopic distal gastrectomy PROCEDURE

TLDG

Totally laparoscopic distal gastrectomy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 20-80 years;
• Patients had an Eastern Cooperative Oncology Group performance status score of 0 or 1;
• Patients had histologically confirmed gastric adenocarcinoma (tumor size\<5cm) at clinical stage I-III with T1-4aN0-2M0 excluding T4b or N3 tumors, according to the of the American Joint Committee on Cancer classification system, eighth edition;
• Patients were expected to undergo laparoscopic distal gastrectomy with D2 lymphadenectomy.

You may not qualify if:

• Patients had bulky regional lymph nodes (larger than 3 cm at the long diameter) or possible distant metastasis in preoperative evaluation
• Patients had history of chemotherapy, radiotherapy, immunotherapy or target therapy;
• Patients had any concurrent or previous malignant tumor;
• Patients had unstable cardiovascular, respiratory, kidney, or liver disease and poorly controlled hypertension, diabetes, mental disorders; history of upper abdominal surgery (except laparoscopic cholecystectomy).
• Patients were histologically proven gastric adenocarcinoma (by preoperative gastrofiberscopy).

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Dazhi Xu, PHD, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD,MD

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 15, 2022
• Study Start: September 15, 2022
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)