NCT01043835

Brief Summary

The purpose of this study is to compare the short- and long-term results between the laparoscopy-assisted gastrectomy and the open gastrectomy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
328

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2010

Completed
25 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

June 5, 2012

Status Verified

June 1, 2012

Enrollment Period

5 years

First QC Date

January 6, 2010

Last Update Submit

June 4, 2012

Conditions

Stomach NeoplasmLaparoscopyGastrectomyComplications

Keywords

Stomach NeoplasmLaparoscopygastrectomy

Outcome Measures

Primary Outcomes (1)

  • Disease free survival

    3 years

Secondary Outcomes (1)

  • Complications, recurrence, quality of life measured by EORTC QLQ-C30 V 3.0 and EORTC QLQ-STO22

    3 years

Study Arms (2)

Laparoscopy-assisted gastrectomy

EXPERIMENTAL
Procedure: Laparoscopy-assisted gastrectomy

Open gastrectomy

ACTIVE COMPARATOR
Procedure: Open gastrectomy

Interventions

Laparoscopy-assisted gastrectomyPROCEDURE

A 10-mm trocar for laparoscope was inserted below the umbilicus. Another 10-mm trocar was introduced in the left preaxillary line 2 cm below the costal margin as a major hand port，and a 5-mm trocar was placed at the contralateral site for traction. A 5-mm trocar was inserted in the left midclavicular line 2 cm above the umbilicus as an accessory port, and a 15-mm trocar also as an accessory port was placed at the contralateral site. The operator stood on the left side of the patient. Subtotal or total gastrectomy and D2 lymph node dissection will be performed basically. As a general rule, Billroth I, Billroth II or Roux-Y method was used for gastric reconstruction. Dissected stomach and lymph node are collected through additional 5 cm incision at a median superior abdominal incision.

Laparoscopy-assisted gastrectomy
Open gastrectomyPROCEDURE

Approximately 15\~20 cm length incision is made from falciform process to periumbilical area. Subtotal or total gastrectomy and D2 lymph node dissection will be performed basically. As a general rule, Billroth I, Billroth II or Roux-Y method was used for gastric reconstruction for all cases.

Open gastrectomy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically proven gastric adenocarcinoma
  • Age:older than 18 years old,younger than 80 years old
  • Preoperative stage(CT, GFS stage):cT2N0M0, cT2N1M0, cT2N2M0, cT3N0M0, cT3N1M0,cT3N2M0
  • ASA score:≤3
  • Patients with an invasion of the gastric serosa exceeding 10 cm2 according to ultrasound examination or examination during surgery were excluded
  • No history of other cancer
  • No history of chemotherapy or radiotherapy
  • Written informed consent

You may not qualify if:

  • Concurrent cancer patients or patient who was treated due to other types of cancer before the patient was diagnosed as a gastric cancer patient
  • Patient who was treated by other types of treatment methods, such as chemotherapy, immunotherapy, or radiotherapy
  • Patient who was received upper abdominal surgery (except, laparoscopic cholecystectomy)
  • ASA score:\>3
  • Contraindication of laparoscopy: severe cardiac disease, abdominal wall hernias, diaphragmatic hernias, uncorrected coagulopathies, portal hypertension, pregnancy
  • Complicated case needed to get emergency operation
  • Any accompanying surgical condition needed to be performed in same time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of General Surgery and Center of Microinvasive Gastrointestinal Surgery, Southwest Hospital

Chongqing, Chong Qing, 400038, China

Location

Southwest Hospital, China

Chongqing, Chong Qing, 400038, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Department of General Surgery and Center of Microinvasive Gastrointestinal Surgery

Study Record Dates

First Submitted

January 6, 2010

First Posted

January 7, 2010

Study Start

February 1, 2010

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

June 5, 2012

Record last verified: 2012-06

Locations

CN(2)