Comparison of laparoscopic versus open radical gastrectomy for advanced gastric cancer

ISRCTN ISRCTN07461728
DOI https://doi.org/10.1186/ISRCTN07461728
ClinicalTrials.gov number NCT01043835
Secondary identifying numbers N/A
Submission date
22/01/2010
Registration date
18/03/2010
Last edited
11/04/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Yu Pei Wu
Scientific

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

Study information

Study designProspective randomised trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleComparison of laparoscopic versus open radical gastrectomy for advanced gastric cancer: a prospective randomised controlled trial
Study objectivesThe 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(s)Ethics Committee of Southwest Hospital, Third Military Medical University, approved on the 24th September 2009 (ref: KY200908)
Health condition(s) or problem(s) studiedAdvanced gastric cancer
InterventionLaparoscopy-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 typeOther
Primary outcome measureDisease free survival at 3 years
Secondary outcome measuresComplications, recurrence, quality of life measured by EORTC QLQ-C30 V 3.0 and EORTC QLQ-STO22 at 3 years
Overall study start date01/02/2010
Completion date31/01/2015

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants328
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/02/2010
Date of final enrolment31/01/2015

Locations

Countries of recruitment

  • China

Study participating centre

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

Sponsor information

Southwest Hospital (China)
Hospital/treatment centre

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

http://english.swhospital.com/default.aspx
ROR logo https://ror.org/02jn36537

Funders

Funder type

Government

Chongqing Municipal Government (China) - Science and Technology Research

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2018 11/04/2019 Yes No
Results article results 01/06/2019 11/04/2019 Yes No

Editorial Notes

11/04/2019: Publication reference added.

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