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

April 27, 2026 updated by: Yun-Suhk Suh, Seoul National University Bundang Hospital

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Since two cases of single-incision laparoscopic gastrectomy in early gastric cancer were reported in 2011, the safety and efficacy of single-incision laparoscopic gastrectomy in early gastric cancer have been reported several times.

Recently, the feasibility of laparoscopic single-incision gastrectomy in some advanced gastric cancer has already been reported.

The total number of retrieved lymph nodes during gastric cancer surgery is one of the most important indicators for securing oncological safety and predicting the therapeutic effect in gastric cancer surgery.

Therefore, in order to prospectively evaluate the efficacy of single-incision or reduced-port laparoscopic gastrectomy for advanced gastric cancer as an oncological operation, the purpose of this study is to evaluate the number of resected lymph nodes after D2 lymph node dissection in single-incision or reduced-port laparoscopic gastrectomy for advanced gastric cancer.

All surgeries are performed as single-incision laparoscopic surgery using a 3-4 cm umbilical incision, and D2 lymph node dissection is performed according to the Japanese gastric cancer treatment guidelines 2018 by the Japanese Gastric Cancer Association.

When an additional trocar is required, it is classified as reduced port laparoscopy when one additional trocar is added.

For surgical assistance, including effective visual field development during surgery, a self intra-corporeal retractor (FJ clip®, or Internal organ retractor®) or an additional trocar (up to 1 trocar) could be used.

An articulating laparoscopic surgical instrument (Artisential ®) can be used for safe access to difficult areas of the D2 lymph node dissection, such as the superior border of the pancreas.

Before the end of the surgery, the surgeon evaluates the completeness of D2 lymph node dissection and radical resection of the primary tumor(R0 resection). If insufficient, the operation is converted to multi-port laparoscopic surgery or open surgery, and additional D2 lymph node dissection and tumor resection are performed, and those cases are recorded separately in the registry as multiport/open conversion.

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single port or reduced ports
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 laparoscopic distal gastrectomy and D2 lymph node dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of retrieved lymph nodes
Time Frame: during operation
number of retrieved lymph nodes during operation
during operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative complications
Time Frame: 3 year
Postoperative complications are problems that can happen after participants have had surgery but which were not intended.
3 year
Quality of life of the participants
Time Frame: 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
The patient's quality of life is assessed using the widely used quality of life questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), sto22) 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, respectively.
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
Time Frame: 3 year
3 year relapse-free survival
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: YunSuhk Suh, M.D., Ph.D., ysksuh@gmail.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2021

Primary Completion (Actual)

December 31, 2024

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

September 29, 2021

First Submitted That Met QC Criteria

October 12, 2021

First Posted (Actual)

October 13, 2021

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-2107-696-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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