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

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

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.

Study Overview

• Status: Completed
• Conditions: Gastric Cancer
• Intervention / Treatment: Procedure: laparoscopy-assisted distal gastrectomy Group; Procedure: Totally laparoscopic distal gastrectomy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 213
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged 20-80 years;
2. Patients had an Eastern Cooperative Oncology Group performance status score of 0 or 1;
3. 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;
4. Patients were expected to undergo laparoscopic distal gastrectomy with D2 lymphadenectomy.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Laparoscopy-assisted distal gastrectomy; The patients who are assigned to LADG group undergo extracorporeal anasto- mosis for gastrointestinal reconstruction.	Procedure: laparoscopy-assisted distal gastrectomy Group; LADG
Experimental: Totally laparoscopic distal gastrectomy; 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; TLDG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scores on the other scales of EORTC QLQ-C30 questionnaire postoperatively	Scores on the other scales of EORTC QLQ-C30 questionnaire at 30 days postoperatively	30 days postoperatively
Scores on EORTC QLQ-C30 questionnaire	Scores on EORTC QLQ-C30 questionnaire at 7 days and 90 days postoperatively	7 days and 90 days postoperatively
Scores on the scales of EORTC QLQ-STO22 questionnaire postoperatively	Scores on the scales of EORTC QLQ-STO22 questionnaire at 7，30 and 90 days postoperatively	7，30 and 90 days postoperatively

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Dazhi Xu, PHD, MD, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Actual): January 15, 2025
• Study Completion (Actual): January 15, 2025

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 23, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Gastric cancer，Laparoscopic distal gastrectomy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: LATDG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No