AzTrials
AzTrials

Gastric CancerNCT05051670

da Vinci SP Robotic Gastrectomy

A study testing da vinc SP gastrectomy in people with 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
Search all trials

Trial summary

Laparoscopic surgery revolutionized the surgical treatment of gastric cancer saving large incsion and associated pain. Robotic surgical system was introduced to enhance the minimally invasive surgery using articulating robotic arm. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Gastric Cancer
What is being tested?
da vinc SP gastrectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteSouth Korea
Study dates
16 Dec 2021to 11 Dec 2022
Phase
Interventional
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Biopsy confirmed adenocarcinoma of stomach scheduled to undergo radical gastrectomy
  • Between 20-80
  • ASA score (American society of anesthesiology) class: I - III
  • Signed to informed consent after through explanation about the study

Who cannot join

  • distant metastasis
  • EMR/ESD canddiate
  • complicated gastric cancer (obstruction or perforation)
  • Active other primary tumor
  • Vulerable subject (illiterate, pregnant)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Severance Hospital, Yonsei University Health System

    Seoul

Other trials in South Korea

About this study

Official title: The Safety and Feasibility of Reduced Port Robotic Distal Gastrectomy Using da Vinci SP for Early Gastric Cancer

Laparoscopic surgery revolutionized the surgical treatment of gastric cancer saving large incsion and associated pain. Robotic surgical system was introduced to enhance the minimally invasive surgery using articulating robotic arm. The da vinci SP system, which enables single-port surgery, can allow surgeon to provide radical gastrectomy with minimal scar and associated pain.

Read the detailed description

This study is a phase 1/2, single-arm surgical clinical trial. The primary endpoint is the safety of da vinci robotic gastrectomy. The secondary endpoint is operative time, bleeding, bowel recovery, and hospital stay. In the clinic, informed consent is received from patient who is scheduled to undergo radical gastrectomy. After the general anesthesia, low midline transverse incision is made at suprapubic area. After inserting SP port into the peritoneal cavity, additional port is inserted via right flank that would be used for assistant's energy device and suction devices. Radical subtotal gastrectomy is perfromed using cardiere-forceps, monopolar scissors, and maryland forceps. Reconstruction after gastrectomy is decided according to surgeon's preference. three days after gastrectomy, if the diet build up is complete and the patients has no evidence of complication, the patient is discharged from the hospital. Four weeks after gastrectomy, the patient will be followed up at the clinic. Major complication event within 30days after gastrectomy will be analyzed as primary endpoint as well as other secondary endpoints.

Conditions
Gastric Cancer
Being tested
da vinc SP gastrectomy
Keywords
da vinci SP, robotic surgery, gastrectomy, gastric cancer
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • da vinc SP gastrectomyProcedure or surgery

    radical subtotal gastrectomy performed by da vinci SP

Study groups in NCT05051670
Study groupRoleWhat they receive
SP groupExperimentalpatients group underwent gastrectomy using da vinci SP
Receives: Procedure: da vinc SP gastrectomy

What is being measured

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

  1. major complication

    Clavien-Dindo classification grade 3 or more

    Measured: 30 days after gastrectomy

Secondary outcomes (4)

  1. Operation time

    duation of operation in minutes

    Measured: 30 days after gastrectomy

  2. bleeding

    amount of bleeding shed during the operation in ml

    Measured: 30 days after gastrectomy

  3. bowel recovery

    gas passing day after the surgery

    Measured: 30 days after gastrectomy

  4. Hospital stay

    days between the opeation day to discharge day

    Measured: 30 days after gastrectomy

Timeline

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

  1. First posted21 Sep 2021
  2. Study start16 Dec 2021
  3. Primary completion11 Nov 2022
  4. Study completion11 Dec 2022

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05051670
Sponsor's protocol ID
4-2021-0881
Status last verified
Jun 2023
First submitted
10 Sep 2021
Last updated
27 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jeong O, Park YK. Clinicopathological features and surgical treatment of gastric cancer in South Korea: the results of 2009 nationwide survey on surgically treated gastric cancer patients. J Gastric Cancer. 2011 Jun;11(2):69-77. doi: 10.5230/jgc.2011.11.2.69. Epub 2011 Jun 30.

    PubMed 22076206

  • Lee JH, Kim KM, Cheong JH, Noh SH. Current management and future strategies of gastric cancer. Yonsei Med J. 2012 Mar;53(2):248-57. doi: 10.3349/ymj.2012.53.2.248.

    PubMed 22318810

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

    PubMed 8180768

  • 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

  • Zeng YK, Yang ZL, Peng JS, Lin HS, Cai L. Laparoscopy-assisted versus open distal gastrectomy for early gastric cancer: evidence from randomized and nonrandomized clinical trials. Ann Surg. 2012 Jul;256(1):39-52. doi: 10.1097/SLA.0b013e3182583e2e.

    PubMed 22664559

  • Kim YM, Baek SE, Lim JS, Hyung WJ. Clinical application of image-enhanced minimally invasive robotic surgery for gastric cancer: a prospective observational study. J Gastrointest Surg. 2013 Feb;17(2):304-12. doi: 10.1007/s11605-012-2094-0. Epub 2012 Dec 1.

    PubMed 23207683

  • Cruz CJ, Huynh F, Kang I, Lee WJ, Kang CM. Initial experiences of robotic SP cholecystectomy: a comparative analysis with robotic Si single-site cholecystectomy. Ann Surg Treat Res. 2021 Jan;100(1):1-7. doi: 10.4174/astr.2021.100.1.1. Epub 2020 Dec 30.

    PubMed 33457391

  • Kang SK, Jang WS, Kim SW, Kim SH, Han SW, Lee YS. Robot-assisted laparoscopic single-port pyeloplasty using the da Vinci SP(R) system: initial experience with a pediatric patient. J Pediatr Urol. 2019 Oct;15(5):576-577. doi: 10.1016/j.jpurol.2019.08.003. Epub 2019 Aug 15.

    PubMed 31570233

  • Gomes MTV, Machado AMN, Podgaec S, Barison GAS. Initial experience with single-port robotic hysterectomy. Einstein (Sao Paulo). 2017 Oct-Dec;15(4):476-480. doi: 10.1590/S1679-45082017AO4134.

    PubMed 29364368

  • Tokunaga M, Sugisawa N, Kondo J, Tanizawa Y, Bando E, Kawamura T, Terashima M. Early phase II study of robot-assisted distal gastrectomy with nodal dissection for clinical stage IA gastric cancer. Gastric Cancer. 2014;17(3):542-7. doi: 10.1007/s10120-013-0293-3. Epub 2013 Sep 5.

    PubMed 24005955

  • Lee S, Kim JK, Kim YN, Jang DS, Kim YM, Son T, Hyung WJ, Kim HI. Safety and feasibility of reduced-port robotic distal gastrectomy for gastric cancer: a phase I/II clinical trial. Surg Endosc. 2017 Oct;31(10):4002-4009. doi: 10.1007/s00464-017-5435-y. Epub 2017 Feb 15.

    PubMed 28205030

  • Park JY, Jo MJ, Nam BH, Kim Y, Eom BW, Yoon HM, Ryu KW, Kim YW, Lee JH. Surgical stress after robot-assisted distal gastrectomy and its economic implications. Br J Surg. 2012 Nov;99(11):1554-61. doi: 10.1002/bjs.8887.

    PubMed 23027072

  • Kim HH, Han SU, Kim MC, Hyung WJ, Kim W, Lee HJ, Ryu SW, Cho GS, Song KY, Ryu SY. Long-term results of laparoscopic gastrectomy for gastric cancer: a large-scale case-control and case-matched Korean multicenter study. J Clin Oncol. 2014 Mar 1;32(7):627-33. doi: 10.1200/JCO.2013.48.8551. Epub 2014 Jan 27.

    PubMed 24470012

  • Tokunaga M, Kondo J, Tanizawa Y, Bando E, Kawamura T, Terashima M. Postoperative intra-abdominal complications assessed by the Clavien-Dindo classification following open and laparoscopy-assisted distal gastrectomy for early gastric cancer. J Gastrointest Surg. 2012 Oct;16(10):1854-9. doi: 10.1007/s11605-012-1981-8. Epub 2012 Jul 31.

    PubMed 22847575

  • Kim SM, Ha MH, Seo JE, Kim JE, Choi MG, Sohn TS, Bae JM, Kim S, Lee JH. Comparison of Reduced Port Totally Laparoscopic Distal Gastrectomy (Duet TLDG) and Conventional Laparoscopic-Assisted Distal Gastrectomy. Ann Surg Oncol. 2015 Aug;22(8):2567-72. doi: 10.1245/s10434-014-4333-y. Epub 2015 Jan 7.

    PubMed 25564174

Questions about this trial

What is this clinical trial studying?

A study testing da vinc SP gastrectomy in people with 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 5 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 27 Jun 2023. 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?

major complication (time frame: 30 days after gastrectomy). 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 NCT05051670, which also lists 16 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 27 Jun 2023; AzTrials last refreshed its copy on 31 Oct 2026.

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