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

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ClinicalTrials.gov Identifier: NCT05541783

Recruitment Status : Recruiting

First Posted : September 15, 2022

Last Update Posted : September 15, 2022

See Contacts and Locations

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Dazhi Xu, Fudan University

Tracking Information

First Submitted Date ^ICMJE

September 6, 2022

First Posted Date ^ICMJE

September 15, 2022

Last Update Posted Date

September 15, 2022

Estimated Study Start Date ^ICMJE

September 15, 2022

Estimated Primary Completion Date

September 15, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Scores on the physical function and pain symptom scales of EORTC QLQ-C30 questionnaire [ Time Frame: 1 months postoperative ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase ^ICMJE

Not Applicable

Study Design ^ICMJE

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

Condition ^ICMJE

Gastric Cancer

Intervention ^ICMJE

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

Study Arms ^ICMJE

Active Comparator: Laparoscopy-assisted distal gastrectomy
The patients who are assigned to LADG group undergo extracorporeal anasto- mosis for gastrointestinal reconstruction.

Intervention: Procedure: laparoscopy-assisted distal gastrectomy Group
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.

Intervention: Procedure: Totally laparoscopic distal gastrectomy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

202

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

September 15, 2025

Estimated Primary Completion Date

September 15, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

20 Years to 80 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Dazhi Xu, PHD, MD

021-64175590

xudzh@shca.org.cn

Listed Location Countries ^ICMJE

China

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT05541783

Other Study ID Numbers ^ICMJE

LATDG

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:

Current Responsible Party

Dazhi Xu, Fudan University

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

Fudan University

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Dazhi Xu, PHD, MD

Fudan University

PRS Account

Fudan University

Verification Date

September 2022

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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