NCT01456598

Brief Summary

  • It was confirmed that the laparoscopic surgery decreases the postoperative pain and reduces the recovery periods in the various surgical fields such as cholecystectomy and colectomy etc. Also, there are clinical evidences that the laparoscopic surgery is applicable to malignant tumor according to the development of surgical techniques and medical instruments.
  • In case of early stage of gastric cancer, as the diverse clinical evidences, the gastrectomy has been commonly applied, however, the opening surgery is still applied for advanced gastric cancer due to lack of clinical evidence.
  • In Korea, approximately 38% of patients who undergo surgery for gastric cancer are diagnosed by T2-T3 (AJCC 6th edition) (www.i-kgca.or.kr, National gastric cancer registration business in 2009). There are various clinical evidences to apply laparoscopic surgery to the patients, however, most of them are retrospective or cohort study results.
  • For the clinical application of surgical treatment regarding locally advanced gastric cancer using laparoscopic surgical technique, it requires the confirmation of definite execution for laparoscopic gastrectomy and D2 lymph node dissection and the safety of surgery and oncological usefulness should be verified.
  • In order for this, it is only possible to confirm through the comparison of short-term surgical results (complications, mortalities, operative time and duration of hospitalization etc) and long-term results (survival rates and recurrence rates etc) between laparoscopic surgery and opening surgery based on the multicenter large-sized randomized prospective study with current standard treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,050

participants targeted

Target at P75+ for not_applicable gastric-cancer

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable gastric-cancer

Geographic Reach
1 country

13 active sites

Status
completed

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

October 11, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 21, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

November 21, 2011

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2018

Completed
Last Updated

November 29, 2018

Status Verified

November 1, 2018

Enrollment Period

6.5 years

First QC Date

October 11, 2011

Last Update Submit

November 27, 2018

Conditions

Gastric Cancer

Keywords

Stomach neoplasmLaparoscopy

Outcome Measures

Primary Outcomes (1)

  • 3 year relapse free survival

    In terms of locally advanced gastric cancer, to examine the non-inferiority of disease free sur-vival rate in laparoscopic subtotal gastrectomy with D2 lymph node dissection at postoperative 3 years compared with open subtotal gastrectomy with D2 lymph node dissection

    36 months

Secondary Outcomes (6)

  • Early postoperative complication

    3 weeks

  • Postoperative mortality

    90 days

  • Late postoperative complication

    36 months

  • Postoperative recovery index

    4 weeks

  • Postoperative quality of life

    preoperative, 3 weeks, 12 months

  • +1 more secondary outcomes

Study Arms (2)

Laparoscopic gastrectomy

EXPERIMENTAL

Laparoscopic subtotal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer.

Procedure: Laparoscopic gastrectomy

Open gastrectomy

ACTIVE COMPARATOR

Open subtotal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer.

Procedure: Open gastrectomy

Interventions

Laparoscopic gastrectomyPROCEDURE

* After laparoscopic observation, the possibility of surgery can be considered by examining inside of abdomen. * The surgeon undergoes laparoscopic subtotal gastrectomy and D2 lymph node dissection * After lymph node dissection, it is possible to undergo gastrectomy on appropriate part and reconstruction under small incision or laparoscopic view. * As the reconstruction, one of the techniques like Billroth I, Billroth II and Roux en Y and so on is applied and there is no limitation on use of appliance.

Also known as: Group A, LDG
Laparoscopic gastrectomy
Open gastrectomyPROCEDURE

* After laparotomy, the possibility of surgery can be considered by examining inside of abdomen. * The surgeon undergoes open subtotal gastrectomy and D2 lymph node dissection * After lymph node dissection, one of the techniques likes Billroth I, Billroth II and Roux en Y and so on is applied and there is no limitation on use of appliance.

Also known as: Group B, ODG
Open gastrectomy

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient from over 20 years to under 80 years
  • The patient with the capability for ECOG (Eastern Cooperative Oncology Group performance status) is ranged between 0 and 1
  • The patient included between ASA score (American society of anesthesiology) class I and III
  • The patient who is diagnosed as gastric adenocarcinoma under preoperative endoscopic biopsy
  • The patient who is diagnosed as locally advanced gastric cancer with the suspicious infiltration of over muscular layer without infiltration on adjacent organs, and without or with lymph node metastasis limited to perigastric or around stomach left gastric artery at the preoperative examination.
  • The patient who is suitable for subtotal resection in the preoperative examination
  • The patient who is fully explained about purpose of trial and contents prior to the participation into this study and signed on the informed consent approved by Institutional Review Board according to own opinion

You may not qualify if:

  • The patient who shows distant metastasis under preoperative examination
  • The patient with medical history for gastrectomy in the past
  • The patient with complication (complete obstruction and perforation) by gastric cancer
  • The patient who undergoes anticancer or radiologic therapy prior to the operation or who undergoes endoscopic submucous dissection for currently diagnosed gastric cancer
  • The patient who undergoes surgery or anti-cancer radiologic therapy for primary cancer within 5 years
  • Vulnerable patients (lack of capacity for decision making, pregnant women (or under planning))
  • The patient who has participated into another clinical trial within recent 6 months or who is participating into another trial
  • The patient with double cancer of activity and synchronization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Department of Surgery , SOON CHUN HYANG UNIVESITY HOSPITAL

Bucheon-si, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, 700-712, South Korea

Location

Copyright National Cancer Center

Goyang-si, South Korea

Location

Chonnam National University Hwasun Hospital

Hwasun, 519-809, South Korea

Location

Incheon St, Mary's Hostpial, The Catholic University of Korea

Incheon, 403-720, South Korea

Location

Dong-A University Hospital

Pusan, 602-715, South Korea

Location

Department of Surgery, Seoul National University BUNDANG Hospital

Seongnam, South Korea

Location

Department of Surgery, Seoul National University Hospital

Seoul, 110-799, South Korea

Location

Yonsei University Severance Hospital

Seoul, 120-752, South Korea

Location

Yeoeuido St. Mary's Hospital, The Catholic University of Korea

Seoul, 150-713, South Korea

Location

Department of surgery, GANGNAM SEVERANCE HOSPITAL

Seoul, South Korea

Location

EWHA Womans university medical center

Seoul, South Korea

Location

Ajou University Hospital

Suwon, 443-749, South Korea

Location

Related Publications (6)

  • Kitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994 Apr;4(2):146-8.

    PMID: 8180768BACKGROUND

  • Kim W, Song KY, Lee HJ, Han SU, Hyung WJ, Cho GS. The impact of comorbidity on surgical outcomes in laparoscopy-assisted distal gastrectomy: a retrospective analysis of multicenter results. Ann Surg. 2008 Nov;248(5):793-9. doi: 10.1097/SLA.0b013e3181887516.

    PMID: 18948806BACKGROUND

  • Kim HH, Hyung WJ, Cho GS, Kim MC, Han SU, Kim W, Ryu SW, Lee HJ, Song KY. Morbidity and mortality of laparoscopic gastrectomy versus open gastrectomy for gastric cancer: an interim report--a phase III multicenter, prospective, randomized Trial (KLASS Trial). Ann Surg. 2010 Mar;251(3):417-20. doi: 10.1097/SLA.0b013e3181cc8f6b.

    PMID: 20160637BACKGROUND

  • Sakuramoto S, Sasako M, Yamaguchi T, Kinoshita T, Fujii M, Nashimoto A, Furukawa H, Nakajima T, Ohashi Y, Imamura H, Higashino M, Yamamura Y, Kurita A, Arai K; ACTS-GC Group. Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med. 2007 Nov 1;357(18):1810-20. doi: 10.1056/NEJMoa072252.

    PMID: 17978289BACKGROUND

  • Son SY, Hur H, Hyung WJ, Park YK, Lee HJ, An JY, Kim W, Kim HI, Kim HH, Ryu SW, Kim MC, Kong SH, Cho GS, Kim JJ, Park DJ, Ryu KW, Kim YW, Kim JW, Lee JH, Yang HK, Han SU; Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS) Group. Laparoscopic vs Open Distal Gastrectomy for Locally Advanced Gastric Cancer: 5-Year Outcomes of the KLASS-02 Randomized Clinical Trial. JAMA Surg. 2022 Oct 1;157(10):879-886. doi: 10.1001/jamasurg.2022.2749.

    PMID: 35857305DERIVED

  • Hyung WJ, Yang HK, Park YK, Lee HJ, An JY, Kim W, Kim HI, Kim HH, Ryu SW, Hur H, Kim MC, Kong SH, Cho GS, Kim JJ, Park DJ, Ryu KW, Kim YW, Kim JW, Lee JH, Han SU; Korean Laparoendoscopic Gastrointestinal Surgery Study Group. Long-Term Outcomes of Laparoscopic Distal Gastrectomy for Locally Advanced Gastric Cancer: The KLASS-02-RCT Randomized Clinical Trial. J Clin Oncol. 2020 Oct 1;38(28):3304-3313. doi: 10.1200/JCO.20.01210. Epub 2020 Aug 20.

    PMID: 32816629DERIVED

Related Links

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • San-Uk Han, M.D., Ph.D.

    Department of Surgery, Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Surgery, Ajou University School of Medicine

Study Record Dates

First Submitted

October 11, 2011

First Posted

October 21, 2011

Study Start

November 21, 2011

Primary Completion

June 2, 2018

Study Completion

June 2, 2018

Last Updated

November 29, 2018

Record last verified: 2018-11

Locations

KR(13)