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SurgeryPhase 3NCT05035446

Short-term Outcomes of SILS+1 Versus CLS for Distal Gastric Cancer

A Phase 3 study testing single-incision plus one-port laparoscopic surgery and conventional laparoscopic surgery in people with Surgery, run by Fujian Cancer Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To evaluate the short-term outcomes of single-incision plus one-port laparoscopic surgery (SILS + 1) versus conventional laparoscopic surgery(CLS) for distal gastric cancer whose clinical stage was cT1-3N0-2M0 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Surgery
What is being tested?
single-incision plus one-port laparoscopic surgery and conventional laparoscopic surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
1 Oct 2021to 31 Aug 2022
Phase
Phase 3
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • pathological diagnosis of gastric cancer
  • clinically diagnosed cT1b-3N0-2M0 lesions according to the 8th Edition of the American Joint Committee on Cancer(AJCC) Cancer Staging Manual(measured using abdominal CT)
  • tumor size ≤ 5cm
  • planned to conduct subtotal gastrectomy

Who cannot join

  • preoperative radiotherapy and chemotherapy
  • tumor perforation
  • severe mental disease

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

    Wenhao Teng, 13600815361, fjtengwh@163.com

    Recruiting

Other trials in China

About this study

Official title: A Prospective Randomized Controlled Study of the Short-term Efficacy of Single-hole Plus One-hole Total Laparoscopic Surgery Versus Five-hole Total Laparoscopic Surgery for Distal Gastric Cancer

To evaluate the short-term outcomes of single-incision plus one-port laparoscopic surgery (SILS + 1) versus conventional laparoscopic surgery(CLS) for distal gastric cancer whose clinical stage was cT1-3N0-2M0

Read the detailed description

The gastric cancer patients with cT1-3N0-2M0 were randomized at a 1:1 ratio to the CLS group or the SILS+1group, then it will evaluate the short-term outcomes between two groups.

Conditions
Surgery
Being tested
single-incision plus one-port laparoscopic surgery, conventional laparoscopic surgery

What participants receive

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

  • single-incision plus one-port laparoscopic surgeryProcedure or surgery

    The investigators use the technique of adding one operation hole on the basis of single-port laparoscopy in some patients.

  • conventional laparoscopic surgeryProcedure or surgery

    It usually requires 5 perforations ports and an auxiliary small incision to perform laparoscopic gastrectomy.

Study groups in NCT05035446
Study groupRoleWhat they receive
single-incision plus one-port laparoscopic surgery(SILS + 1)ExperimentalIt requires an auxiliary small incision and one more port to perform laparoscopic gastrectomy
Receives: Procedure: single-incision plus one-port laparoscopic surgery
conventional laparoscopic surgery(CLS)OtherIt requires 5 perforations ports and an auxiliary small incision to perform laparoscopic gastrectomy
Receives: Procedure: conventional laparoscopic surgery

What is being measured

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

  1. Rate of complications

    It means the rate of intraoperative and postoperative complications

    Measured: It is within 30 days after surgery

Secondary outcomes (2)

  1. Rate of death

    It means the rate of death after operation

    Measured: It is within 30 days after surgery

  2. pain intensity

    The investigators use Visual analogue scale(VAS) to evaluate the intensity of pain

    Measured: 1-3 days after operation

Timeline

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

  1. First posted5 Sep 2021
  2. Study start1 Oct 2021
  3. Primary completion31 Jul 2022 (estimated)
  4. Study completion31 Aug 2022 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05035446
Sponsor's protocol ID
SILS+1-GC-001
Status last verified
Sep 2021
First submitted
26 Aug 2021
Last updated
11 Oct 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kunisaki C, Miyamoto H, Sato S, Tanaka Y, Sato K, Izumisawa Y, Yukawa N, Kosaka T, Akiyama H, Saigusa Y, Sakamaki K, Yamanaka T, Endo I. Surgical Outcomes of Reduced-Port Laparoscopic Gastrectomy Versus Conventional Laparoscopic Gastrectomy for Gastric Cancer: A Propensity-Matched Retrospective Cohort Study. Ann Surg Oncol. 2018 Nov;25(12):3604-3612. doi: 10.1245/s10434-018-6733-x. Epub 2018 Sep 3.

    PubMed 30178393

  • Kashiwagi H, Kumagai K, Monma E, Nozue M. Dual-port distal gastrectomy for the early gastric cancer. Surg Endosc. 2015 Jun;29(6):1321-6. doi: 10.1007/s00464-014-3827-9. Epub 2014 Aug 27.

    PubMed 25159658

  • Zhou W, Dong CZ, Zang YF, Xue Y, Zhou XG, Wang Y, Ding YL. Initial experience of single-incision plus one port left-side approach totally laparoscopic distal gastrectomy with uncut Roux-en-Y reconstruction. World J Gastroenterol. 2020 Aug 21;26(31):4669-4679. doi: 10.3748/wjg.v26.i31.4669.

    PubMed 32884224

  • Kunisaki C, Makino H, Kimura J, Takagawa R, Ota M, Kosaka T, Akiyama H, Endo I. Application of reduced-port laparoscopic total gastrectomy in gastric cancer preserving the pancreas and spleen. Gastric Cancer. 2015 Oct;18(4):868-75. doi: 10.1007/s10120-014-0441-4. Epub 2014 Nov 15.

    PubMed 25398519

  • 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

  • Yang X, Bu Z, He M, Lin Y, Jiang Y, Chen D, Liu K, Zhou J. Effectiveness and safety of reduced-port laparoscopic surgery vs conventional multi-port laparoscopic surgery in the treatment of gastric diseases: A meta-analysis. Medicine (Baltimore). 2021 Jan 22;100(3):e23941. doi: 10.1097/MD.0000000000023941.

    PubMed 33545969

  • Kim SM, Ha MH, Seo JE, Kim JE, Choi MG, Sohn TS, Bae JM, Kim S, Lee JH. Comparison of single-port and reduced-port totally laparoscopic distal gastrectomy for patients with early gastric cancer. Surg Endosc. 2016 Sep;30(9):3950-7. doi: 10.1007/s00464-015-4706-8. Epub 2015 Dec 22.

    PubMed 26694180

  • Kim HG, Kim DY, Jeong O. Transition from Conventional to Reduced-Port Laparoscopic Gastrectomy to Treat Gastric Carcinoma: a Single Surgeon's Experience from a Small-Volume Center. J Gastric Cancer. 2018 Jun;18(2):172-181. doi: 10.5230/jgc.2018.18.e18. Epub 2018 Jun 27.

    PubMed 29984067

  • Lu YM, Lin T, Hu YF, Liu H, Mou TY, Zhu Y, Yu J, Li GX. Initial Experience of Dual-Port Laparoscopic Distal Gastrectomy for Gastric Cancer: A Single-Arm Study. Adv Ther. 2019 Sep;36(9):2342-2350. doi: 10.1007/s12325-019-01029-x. Epub 2019 Jul 23.

    PubMed 31338689

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing single-incision plus one-port laparoscopic surgery and conventional laparoscopic surgery in people with Surgery, run by Fujian Cancer Hospital at 1 site in China.

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 3 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: status not confirmed, as of the sponsor's last update on 11 Oct 2021. 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 China. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of complications (time frame: It is within 30 days after surgery). 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 NCT05035446, 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 11 Oct 2021.

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