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

Surgery Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05035446
• Other study ID #: SILS+1-GC-001
• Status: Recruiting
• Phase: Phase 3
• Start date: October 1, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: September 2021
• Source: Fujian Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Stomach Neoplasms
• Surgery

Intervention

Procedure:
• 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.
• conventional laparoscopic surgery
It usually requires 5 perforations ports and an auxiliary small incision to perform laparoscopic gastrectomy.

Locations

Country	Name	City	State
China	Fujian Cancer Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

Country where clinical trial is conducted

China, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of complications	It means the rate of intraoperative and postoperative complications	It is within 30 days after surgery
Secondary	Rate of death	It means the rate of death after operation	It is within 30 days after surgery
Secondary	pain intensity	The investigators use Visual analogue scale(VAS) to evaluate the intensity of pain	1-3 days after operation