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

NCT05035446 | Unknown Phase 3

• 1 other identifier: SILS+1-GC-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

• Rate of complications

  It means the rate of intraoperative and postoperative complications

  It is within 30 days after surgery

Secondary Outcomes (2)

• Rate of death

  It is within 30 days after surgery

• pain intensity

  1-3 days after operation

Study Arms (2)

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

EXPERIMENTAL

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

Procedure: single-incision plus one-port laparoscopic surgery

conventional laparoscopic surgery(CLS)

OTHER

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

Procedure: conventional laparoscopic surgery

Interventions

single-incision plus one-port laparoscopic surgery PROCEDURE

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

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

conventional laparoscopic surgery PROCEDURE

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

conventional laparoscopic surgery(CLS)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

RECRUITING

Related Publications (9)

• 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.

  PMID: 30178393 BACKGROUND

• 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.

  PMID: 25159658 BACKGROUND

• 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.

  PMID: 32884224 BACKGROUND

• 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.

  PMID: 25398519 BACKGROUND

• 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.

  PMID: 25564174 BACKGROUND

• 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.

  PMID: 33545969 BACKGROUND

• 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.

  PMID: 26694180 BACKGROUND

• 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.

  PMID: 29984067 BACKGROUND

• 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.

  PMID: 31338689 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 5, 2021
• Study Start: October 1, 2021
• Primary Completion: July 31, 2022
• Study Completion: August 31, 2022
• Last Updated: October 11, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)