This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05541783
Recruitment Status : Recruiting
First Posted : September 15, 2022
Last Update Posted : September 15, 2022
Sponsor:
Information provided by (Responsible Party):
Dazhi Xu, Fudan University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Procedure: laparoscopy-assisted distal gastrectomy Group Procedure: Totally laparoscopic distal gastrectomy Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : September 15, 2022
Estimated Primary Completion Date : September 15, 2024
Estimated Study Completion Date : September 15, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Usage of analgesics [ Time Frame: 1-7 day postoperative ]
    Usage of analgesics postoperatively

  4. Length of stay [ Time Frame: 1 months postoperative ]
    Length of stay

  5. 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

  6. Scores on ST22 questionnaire [ Time Frame: 7 day and 1 months postoperative ]
    Scores on ST22 questionnaire at 7 day and 1 months postoperative


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05541783


Contacts
Layout table for location contacts
Contact: Dazhi Xu, PHD, MD 021-64175590 xudzh@shca.org.cn

Locations
Layout table for location information
China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China
Contact: Dazhi Xu, PHD，MD    021-64175590    xudzh@shca.org.cn   
Sponsors and Collaborators
Fudan University
Investigators
Layout table for investigator information
Principal Investigator: Dazhi Xu, PHD, MD Fudan University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Dazhi Xu, PHD,MD, Fudan University
ClinicalTrials.gov Identifier: NCT05541783    
Other Study ID Numbers: LATDG
First Posted: September 15, 2022    Key Record Dates
Last Update Posted: September 15, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dazhi Xu, Fudan University:
Gastric cancer，Laparoscopic distal gastrectomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases