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

Primary Purpose

Gastric Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
laparoscopy-assisted distal gastrectomy Group
Totally laparoscopic distal gastrectomy
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric cancer，Laparoscopic distal gastrectomy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Laparoscopy-assisted distal gastrectomy

Totally laparoscopic distal gastrectomy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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 1 months postoperative

Secondary Outcome Measures

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

Full Information

First Posted
September 6, 2022
Last Updated
September 12, 2022
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05541783
Brief Title
Laparoscopic-assisted Distal Gastrectomy and Totally Laparoscopic Distal Gastrectomy for Gastric Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Anticipated)
Primary Completion Date
September 15, 2024 (Anticipated)
Study Completion Date
September 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Gastric cancer，Laparoscopic distal gastrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
202 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopy-assisted distal gastrectomy
Arm Type
Active Comparator
Arm Description
The patients who are assigned to LADG group undergo extracorporeal anasto- mosis for gastrointestinal reconstruction.
Arm Title
Totally laparoscopic distal gastrectomy
Arm Type
Experimental
Arm Description
The patients who are allocated to TLDG group undergo intracorporeal anastomosis for the recovery of gastrointes- tinal continuity after gastrectomy.
Intervention Type
Procedure
Intervention Name(s)
laparoscopy-assisted distal gastrectomy Group
Intervention Description
LADG
Intervention Type
Procedure
Intervention Name(s)
Totally laparoscopic distal gastrectomy
Intervention Description
TLDG
Primary Outcome Measure Information:
Title
Scores on the physical function and pain symptom scales of EORTC QLQ-C30 questionnaire
Description
Scores on the physical function and pain symptom scales of EORTC QLQ-C30 questionnaire at 1 months postoperative
Time Frame
1 months postoperative
Secondary Outcome Measure Information:
Title
Scores on the other scales of EORTC QLQ-C30 questionnaire postoperative
Description
Scores on the other scales of EORTC QLQ-C30 questionnaire at 1 months postoperative
Time Frame
1 months postoperative
Title
Scores on EORTC QLQ-C30 questionnaire
Description
Scores on EORTC QLQ-C30 questionnaire at 7 day and 1 months postoperative
Time Frame
7 day and 1 months postoperative
Title
Usage of analgesics
Description
Usage of analgesics postoperatively
Time Frame
1-7 day postoperative
Title
Length of stay
Description
Length of stay
Time Frame
1 months postoperative
Title
Scores on the other scales of ST22 questionnaire postoperative
Description
Scores on the other scales of ST22 questionnaire at 1 months postoperative
Time Frame
1 months postoperative
Title
Scores on ST22 questionnaire
Description
Scores on ST22 questionnaire at 7 day and 1 months postoperative
Time Frame
7 day and 1 months postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dazhi Xu, PHD, MD
Phone
021-64175590
Email
xudzh@shca.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dazhi Xu, PHD, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dazhi Xu, PHD，MD
Phone
021-64175590
Email
xudzh@shca.org.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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

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