Safety and Efficacy of Single or Reduced Ports Laparoscopic Gastrectomy for Advanced Gastric Cancer (SPACE-01)

NCT05076279 | Active Not Recruiting

• 1 other identifier: B-2107-696-001
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to verify the safety and efficacy of single or reduced ports laparoscopic gastrectomy for advanced gastric cancer.

Conditions

Gastric Cancer; Gastric Adenocarcinoma

Keywords

Gastric cancer; Gastric adenocarcinoma; Gastrectomy; Single port

Outcome Measures

Primary Outcomes (1)

• number of retrieved lymph nodes

  number of retrieved lymph nodes during operation

  during operation

Secondary Outcomes (3)

• postoperative complications

  3 year

• Quality of life of the participants

  before surgery (within 1 month before the day of surgery), within 1 week after surgery, within 1 month after surgery, within 3 months after surgery, within 6 months after surgery, and within 12 months after surgery

• 3 year relapse-free survival

  3 year

Study Arms (1)

Single port or reduced ports

EXPERIMENTAL

Single port or reduced ports laparoscopic distal gastrectomy and D2 lymph node dissection

Procedure: Single port or reduced ports laparoscopic distal gastrectomy and D2 lymph node dissection

Interventions

Single port or reduced ports laparoscopic distal gastrectomy and D2 lymph node dissection PROCEDURE

Single port or reduced ports laparoscopic distal gastrectomy and D2 lymph node dissection

Single port or reduced ports

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have confirmed that participants have advanced gastric cancer at clinical stage T2 or higher and who can undergo distal gastrectomy for primary gastric cancer who have consented to single-port and reduced-port laparoscopic gastric cancer surgery
• Patients diagnosed with locally advanced gastric cancer in which no enlarged lymph nodes were observed in the preoperative examination, or lymph node metastases confined to the left gastric artery or perigastric area were suspected.
• Those who have not been treated for systemic inflammatory disease before surgery

You may not qualify if:

• Those who have previously had gastrectomy.
• Those who have a laparotomy except for appendectomy, cholecystectomy or cesarean section.
• Patients with clinical (preoperative or intraoperative) stage T4b accompanied by infiltration of surrounding organs
• Those with bulky lymph nodes (single nodules over 3 cm or multiple nodules over 1.5 cm)
• Patients with confirmed distant metastasis (M1)
• Severe liver cirrhosis
• Patients who is judged by the investigator to be inappropriate for this study
• Patients who are taking antithrombotic drugs, including antiplatelet drugs and anticoagulants, and cannot safely stop before surgery

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Related Publications (3)

• Lee JH, Lee MS, Kim HH, Park DJ, Lee HJ, Yang HK, Park KU. Comparison of single-incision laparoscopic distal gastrectomy and laparoscopic distal gastrectomy for gastric cancer in a porcine model. J Laparoendosc Adv Surg Tech A. 2011 Dec;21(10):935-40. doi: 10.1089/lap.2011.0280. Epub 2011 Nov 1.

  PMID: 22044252 BACKGROUND

• Omori T, Fujiwara Y, Moon J, Sugimura K, Miyata H, Masuzawa T, Kishi K, Miyoshi N, Tomokuni A, Akita H, Takahashi H, Kobayashi S, Yasui M, Ohue M, Yano M, Sakon M. Comparison of Single-Incision and Conventional Multi-Port Laparoscopic Distal Gastrectomy with D2 Lymph Node Dissection for Gastric Cancer: A Propensity Score-Matched Analysis. Ann Surg Oncol. 2016 Dec;23(Suppl 5):817-824. doi: 10.1245/s10434-016-5485-8. Epub 2016 Aug 10.

  PMID: 27510844 BACKGROUND

• Omori T, Fujiwara Y, Yamamoto K, Yanagimoto Y, Sugimura K, Masuzawa T, Kishi K, Takahashi H, Yasui M, Miyata H, Ohue M, Yano M, Sakon M. The Safety and Feasibility of Single-Port Laparoscopic Gastrectomy for Advanced Gastric Cancer. J Gastrointest Surg. 2019 Jul;23(7):1329-1339. doi: 10.1007/s11605-018-3937-0. Epub 2018 Sep 5.

  PMID: 30187335 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• YunSuhk Suh, M.D., Ph.D.

  ysksuh@gmail.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 13, 2021
• Study Start: November 15, 2021
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

KR (1)