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Gastric CancerNCT01309256

Multi-institutional Study on the Assessment of Robotic Surgery for Gastric Cancer

An observational study of Gastric Cancer, run by Yonsei University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Minimally invasive surgery revolutionized the field of gastric cancer surgery. The surgical robot was introduced to alleviate the difficulty of laparoscopic surgery. Although many studies have reported successful outcomes for robotic surgery, there is no multicenter prospective analysis regarding the advantage of the… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Gastric Cancer
How many people
1,650 participants
Where
1 siteSouth Korea
Study dates
Mar 2011to Feb 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Gastric cancer patients

Who may be able to join

  • Patients must have documented diagnosis of gastric cancer
  • Patients receiving laparoscopic gastric cancer surgery without preoperative evidence of serosal invasion and distant lymph node metastasis as determined by preoperative CT-scan, upper endoscopy, and endoscopic ultrasound.
  • Patients who have received comprehensive explanation about the planned study, understand and accept all the terms of the study and willingly give consent to participate in all the required elements of the study
  • Any patients who underwent robotic gastrectomy in Korea

Who cannot join

  • Patients without mental competence
  • Patients who are illiterate
  • Patients who are pregnant
  • Patients < 20 years old

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Severance Hospital

    Seoul, Seoul, 120-752

Other trials in South Korea

About this study

Minimally invasive surgery revolutionized the field of gastric cancer surgery. The surgical robot was introduced to alleviate the difficulty of laparoscopic surgery. Although many studies have reported successful outcomes for robotic surgery, there is no multicenter prospective analysis regarding the advantage of the robotic gastrectomy. The aim of this study is to analyze the surgical outcomes of the robotic gastrectomy focusing on the learning curve, cost-effectiveness, quality of life, and acute-inflammatory reaction in comparison with laparoscopic gastrectomy.

Conditions
Gastric Cancer
Keywords
distal gastrectomy, Robotic gastrectomy, registry, learning curve, cost-effectiveness, quality of life, acute inflammatory reaction, Robotic and laparoscopic surgery
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01309256
Study groupRoleWhat they receive
R-robot groupretrospective robot group
P-robot groupprospective robot group
P-laparoscopic groupprospective laparoscopic group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Registration of all robotic gastrectomies performed in South Korea

    Measured: at the end of the study

  2. Learning curve (operation time and surgical outcome) of robotic gastrectomy

    Measured: from the start of the operation to discharge of the patient (usually two weeks after the operation)

  3. Cost-effectiveness comparison between robotic and laparoscopic gastrectomy

    Measured: from admission to discharge of the patient (usually from two days before the operation until two weeks after the operation)

  4. Quality of life after robotic and laparoscopic gastrectomy

    Measured: One day before operation, first OPD visit after the operation (two weeks after the operation), 3M, 12M, 36M, and 60M after the operation

  5. Acute-inflammatory response after undergoing robotic and laparoscopic gastrectomy

    Measured: preop, 2hr, 24hr, 4days and 30 days after the operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Enrolment
1,650 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01309256
Sponsor's protocol ID
4-2010-0659
Status last verified
Jun 2013
First submitted
4 Mar 2011
Last updated
4 Jun 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Song J, Oh SJ, Kang WH, Hyung WJ, Choi SH, Noh SH. Robot-assisted gastrectomy with lymph node dissection for gastric cancer: lessons learned from an initial 100 consecutive procedures. Ann Surg. 2009 Jun;249(6):927-32. doi: 10.1097/01.sla.0000351688.64999.73.

    PubMed 19474671

  • Song J, Kang WH, Oh SJ, Hyung WJ, Choi SH, Noh SH. Role of robotic gastrectomy using da Vinci system compared with laparoscopic gastrectomy: initial experience of 20 consecutive cases. Surg Endosc. 2009 Jun;23(6):1204-11. doi: 10.1007/s00464-009-0351-4. Epub 2009 Mar 5.

    PubMed 19263147

  • Kim MC, Heo GU, Jung GJ. Robotic gastrectomy for gastric cancer: surgical techniques and clinical merits. Surg Endosc. 2010 Mar;24(3):610-5. doi: 10.1007/s00464-009-0618-9. Epub 2009 Aug 18.

    PubMed 19688399

  • Song J, Lee HJ, Cho GS, Han SU, Kim MC, Ryu SW, Kim W, Song KY, Kim HH, Hyung WJ; Korean Laparoscopic Gastrointestinal Surgery Study (KLASS) Group. Recurrence following laparoscopy-assisted gastrectomy for gastric cancer: a multicenter retrospective analysis of 1,417 patients. Ann Surg Oncol. 2010 Jul;17(7):1777-86. doi: 10.1245/s10434-010-0932-4. Epub 2010 Feb 12.

    PubMed 20151217

  • Lee HJ, Kim HH, Kim MC, Ryu SY, Kim W, Song KY, Cho GS, Han SU, Hyung WJ, Ryu SW; Korean Laparoscopic Gastrointestinal Surgery Study Group. The impact of a high body mass index on laparoscopy assisted gastrectomy for gastric cancer. Surg Endosc. 2009 Nov;23(11):2473-9. doi: 10.1007/s00464-009-0419-1. Epub 2009 Apr 3.

    PubMed 19343439

  • Kim MC, Kim W, Kim HH, Ryu SW, Ryu SY, Song KY, Lee HJ, Cho GS, Han SU, Hyung WJ; Korean Laparoscopic Gastrointestinal Surgery Study (KLASS) Group. Risk factors associated with complication following laparoscopy-assisted gastrectomy for gastric cancer: a large-scale korean multicenter study. Ann Surg Oncol. 2008 Oct;15(10):2692-700. doi: 10.1245/s10434-008-0075-z. Epub 2008 Jul 29.

    PubMed 18663532

  • 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.

    PubMed 20160637

  • Kim MS, Kim WJ, Hyung WJ, Kim HI, Han SU, Kim YW, Ryu KW, Park S. Comprehensive Learning Curve of Robotic Surgery: Discovery From a Multicenter Prospective Trial of Robotic Gastrectomy. Ann Surg. 2021 May 1;273(5):949-956. doi: 10.1097/SLA.0000000000003583.

    PubMed 31503017

  • Kim HI, Han SU, Yang HK, Kim YW, Lee HJ, Ryu KW, Park JM, An JY, Kim MC, Park S, Song KY, Oh SJ, Kong SH, Suh BJ, Yang DH, Ha TK, Kim YN, Hyung WJ. Multicenter Prospective Comparative Study of Robotic Versus Laparoscopic Gastrectomy for Gastric Adenocarcinoma. Ann Surg. 2016 Jan;263(1):103-9. doi: 10.1097/SLA.0000000000001249.

    PubMed 26020107

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric Cancer, run by Yonsei University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Registration of all robotic gastrectomies performed in South Korea (time frame: at the end of the study). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01309256, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2013.

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