Condition category
Cancer
Date applied
22/01/2010
Date assigned
18/03/2010
Last edited
18/03/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Yu Pei Wu

ORCID ID

Contact details

Department of General Surgery and Center of Microinvasive Gastrointestinal Surgery
Southwest Hospital
Chongqing
400038
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01043835

Protocol/serial number

N/A

Study information

Scientific title

Comparison of laparoscopic versus open radical gastrectomy for advanced gastric cancer: a prospective randomised controlled trial

Acronym

Study hypothesis

The use of laparoscopic surgery in the management of advanced gastric cancer (AGC) has not yet met with widespread acceptance and remains limited to only a few centres. The purpose of this study is to compare the short- and long-term results between the laparoscopy-assisted gastrectomy and the open gastrectomy.

Ethics approval

Ethics Committee of Southwest Hospital, Third Military Medical University, approved on the 24th September 2009 (ref: KY200908)

Study design

Prospective randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Advanced gastric cancer

Intervention

Laparoscopy-assisted gastrectomy:
One initial 10-mm trocar for a 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. A 5-mm trocar then 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, through which a linear cutter was inserted. A 5-mm trocar was inserted in the right preaxillary line 2 cm below the costal margin for traction and exposure of the liver. 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 for all cases. Dissected stomach and lymph node are collected through additional 3 - 5 cm incision at a median superior abdominal incision.

Open gastrectomy:
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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Disease free survival at 3 years

Secondary outcome measures

Complications, recurrence, quality of life measured by EORTC QLQ-C30 V 3.0 and EORTC QLQ-STO22 at 3 years

Overall trial start date

01/02/2010

Overall trial end date

31/01/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Pathologically proven gastric adenocarcinoma
2. Aged older than 18 years old, younger than 80 years old, either sex
3. Pre-operative stage (computed tomography [CT], gastrofiberscopy [GFS] stage): cT2N0M0, cT2N1M0, cT2N2M0, cT3N0M0, cT3N1M0, cT3N2M0
4. American Society of Anaesthesiologists (ASA) score: less than or equal to 3
5. No invasion of the gastric serosa exceeding 10 cm^2 according to ultrasound examination or examination during surgery
6. No history of other cancer
7. No history of chemotherapy or radiotherapy
8. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

328

Participant exclusion criteria

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

Recruitment start date

01/02/2010

Recruitment end date

31/01/2015

Locations

Countries of recruitment

China

Trial participating centre

Department of General Surgery and Center of Microinvasive Gastrointestinal Surgery
Chongqing
400038
China

Sponsor information

Organisation

Southwest Hospital (China)

Sponsor details

c/o Yu Pei Wu
Ph. D
Department of General Surgery and Center of Microinvasive Gastrointestinal Surgery
Chongqing
400038
China

Sponsor type

Hospital/treatment centre

Website

http://english.swhospital.com/default.aspx

Funders

Funder type

Government

Funder name

Chongqing Municipal Government (China) - Science and Technology Research

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes