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

Not Applicable

Recruiting

• Conditions: Gastric Cancer
• Interventions: Procedure: laparoscopy-assisted distal gastrectomy Group; Procedure: Totally laparoscopic distal gastrectomy

• Registration Number: NCT05541783
• Lead Sponsor: Fudan University

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.

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 Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-06
• Study First Submitted QC: 2022-09-12
• Last Update Submitted: 2022-09-12
• Study Start: 2022-09-15
• Study First Posted: 2022-09-15
• Last Update Posted: 2022-09-15
• Primary Completion: 2024-09-15
• Study Completion: 2025-09-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 202

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopy-assisted distal gastrectomy	laparoscopy-assisted distal gastrectomy Group	The patients who are assigned to LADG group undergo extracorporeal anasto- mosis for gastrointestinal reconstruction.
Totally laparoscopic distal gastrectomy	Totally laparoscopic distal gastrectomy	The patients who are allocated to TLDG group undergo intracorporeal anastomosis for the recovery of gastrointes- tinal continuity after gastrectomy.

Primary Outcome Measures

Name	Time	Method
Scores on the physical function and pain symptom scales of EORTC QLQ-C30 questionnaire	1 months postoperative	Scores on the physical function and pain symptom scales of EORTC QLQ-C30 questionnaire at 1 months postoperative

Secondary Outcome Measures

Name	Time	Method
Usage of analgesics	1-7 day postoperative	Usage of analgesics postoperatively
Length of stay	1 months postoperative	Length of stay
Scores on EORTC QLQ-C30 questionnaire	7 day and 1 months postoperative	Scores on EORTC QLQ-C30 questionnaire at 7 day and 1 months postoperative
Scores on the other scales of ST22 questionnaire postoperative	1 months postoperative	Scores on the other scales of ST22 questionnaire at 1 months postoperative
Scores on ST22 questionnaire	7 day and 1 months postoperative	Scores on ST22 questionnaire at 7 day and 1 months postoperative
Scores on the other scales of EORTC QLQ-C30 questionnaire postoperative	1 months postoperative	Scores on the other scales of EORTC QLQ-C30 questionnaire at 1 months postoperative

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China