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

NCT ID: NCT05035446

Last Updated: 2021-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-08-31

Brief Summary

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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

Detailed Description

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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

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Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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single-incision plus one-port laparoscopic surgery(SILS + 1)

It requires an auxiliary small incision and one more port to perform laparoscopic gastrectomy

Group Type EXPERIMENTAL

single-incision plus one-port laparoscopic surgery

Intervention Type PROCEDURE

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

conventional laparoscopic surgery(CLS)

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

Group Type OTHER

conventional laparoscopic surgery

Intervention Type PROCEDURE

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

Interventions

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single-incision plus one-port laparoscopic surgery

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

Intervention Type PROCEDURE

conventional laparoscopic surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* preoperative radiotherapy and chemotherapy
* tumor perforation
* severe mental disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Cancer Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fujian Cancer Hospital

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Wenhao Teng

Role: primary

13600815361

References

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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.

Reference Type BACKGROUND
PMID: 30178393 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25159658 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32884224 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25398519 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25564174 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33545969 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26694180 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29984067 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31338689 (View on PubMed)

Other Identifiers

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SILS+1-GC-001

Identifier Type: -

Identifier Source: org_study_id

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