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History of Changes for Study: NCT05076279
Safety and Efficacy of Single or Reduced Ports Laparoscopic Gastrectomy for Advanced Gastric Cancer (SPACE-01)
Latest version (submitted November 21, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 12, 2021 None (earliest Version on record)
2 November 3, 2021 Study Status
3 December 12, 2021 Recruitment Status, Study Status and Contacts/Locations
4 August 18, 2022 Study Status and Study Design
5 November 21, 2023 Study Status
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Study NCT05076279
Submitted Date:  October 12, 2021 (v1)
Open or close this module Study Identification
Unique Protocol ID: B-2107-696-001
Brief Title: Safety and Efficacy of Single or Reduced Ports Laparoscopic Gastrectomy for Advanced Gastric Cancer (SPACE-01)
Official Title: Safety and Efficacy of Single or Reduced Ports Laparoscopic Gastrectomy for Advanced Gastric Cancer (SPACE-01) Phase II Clinical Trial
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2021
Overall Status: Not yet recruiting
Study Start: October 4, 2021
Primary Completion: September 30, 2023 [Anticipated]
Study Completion: September 30, 2026 [Anticipated]
First Submitted: September 29, 2021
First Submitted that
Met QC Criteria:		 October 12, 2021
First Posted: October 13, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:		 October 12, 2021
Last Update Posted: October 13, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Seoul National University Bundang Hospital
Responsible Party: Principal Investigator
Investigator: Yun-Suhk Suh
Official Title: Professor
Affiliation: Seoul National University Bundang Hospital
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
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.
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.
Open or close this module Conditions
Conditions: Gastric Cancer
Gastric Adenocarcinoma
Keywords: Gastric cancer
Gastric adenocarcinoma
Gastrectomy
Single port
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 130 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. number of retrieved lymph nodes
[ Time Frame: during operation ]

number of retrieved lymph nodes during operation
Secondary Outcome Measures:
1. postoperative complications
[ Time Frame: 3 year ]

Postoperative complications are problems that can happen after participants have had surgery but which were not intended.
2. 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.
3. 3 year relapse-free survival
[ Time Frame: 3 year ]

3 year relapse-free survival
Open or close this module Eligibility
Minimum Age: 19 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Eunju Lee, M.D.
Telephone: 820317876352
Email: lunajew@gmail.com
Study Officials: YunSuhk Suh, M.D., Ph.D.
Principal Investigator
ysksuh@gmail.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: 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. PubMed 22044252
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. PubMed 27510844
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. PubMed 30187335
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