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

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ClinicalTrials.gov Identifier: NCT05076279
Recruitment Status : Recruiting
First Posted : October 13, 2021
Last Update Posted : November 22, 2023
Sponsor:
Information provided by (Responsible Party):
Yun-Suhk Suh, Seoul National University Bundang Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Gastric Adenocarcinoma Procedure: Single port or reduced ports laparoscopic distal gastrectomy and D2 lymph node dissection Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Single or Reduced Ports Laparoscopic Gastrectomy for Advanced Gastric Cancer (SPACE-01) Phase II Clinical Trial
Actual Study Start Date : November 15, 2021
Estimated Primary Completion Date : August 31, 2025
Estimated Study Completion Date : August 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05076279


Contacts
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Contact: Eunju Lee, M.D. 820317876352 lunajew@gmail.com

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
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Principal Investigator: YunSuhk Suh, M.D., Ph.D. ysksuh@gmail.com
More Information
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Publications:

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Responsible Party: Yun-Suhk Suh, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT05076279    
Other Study ID Numbers: B-2107-696-001
First Posted: October 13, 2021    Key Record Dates
Last Update Posted: November 22, 2023
Last Verified: November 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yun-Suhk Suh, Seoul National University Bundang Hospital:
Gastric cancer
Gastric adenocarcinoma
Gastrectomy
Single port
Additional relevant MeSH terms:
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Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases