Laparoscopic vs Open Total Gastrectomy for Gastric Cancer | NCT05537129

Studies
Laparoscopic vs Open Total Gastrectomy for Gastric Cancer

NCT05537129

Sponsor

Fudan University

Status

Recruiting

Last Update Posted

Sep 13, 2022Actual

Enrollment

600Estimated

Phase

Not Applicable

Conditions

Gastric Cancer

Interventions

Total Gastrectomy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2022Estimated

Primary Completion Date

Oct 1, 2024Estimated

Completion Date

Oct 1, 2027Estimated

First Submitted Date

Sep 8, 2022

First Submission Date that Met QC Criteria

Sep 8, 2022

First Posted Date

Sep 13, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2022

Last Update Posted Date

Sep 13, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the present study is to demonstrated the the safety and feasibility of laparoscopic total gastrectomy comparing with open total gastrectomy.

Detailed Description

Gastric cancer is most common cause of cancer-related deaths in the world. Laparoscopic distal gastrectomy has been demonstrated to be safe and effective compared with open distal gastrectomy. With an increase in incidences of proximal gastric cancer over the last decades, total gastrectomy has been prefered by surgeons, and laparoscopic total gastrectomy has become the alternative option. However, the safety and feasibility of laparoscopic total gastrectomy have yet to be proved completely.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Laparoscopic Total Gastrectomy	Experimental		Procedure: Total Gastrectomy
Open Total Gastrectomy	Active Comparator		Procedure: Total Gastrectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Total Gastrectomy	Procedure	The laparoscopic or open total gastrectomy with D2 lymphadenectomy was performed according to the Japanese gastric cancer treatment guidelines.	Laparoscopic Total Gastrectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
3 year-DFS	3 year-disease free survival	3 year

Secondary Outcomes

Measure	Description	Time Frame
3 year-OS	3 year-overall survival	3 year
morbidity and mortality rates	morbidity and mortality within 30 days following surgeries

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

histologically proven gastric adenocarcinoma in the upper or middle third of the stomach (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 total 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
without preoperative chemotherapy and radiotherapy

Exclusion Criteria:

clinical stage T1-4N3M0 or T4bN0-3M0 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms