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

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

Tracking Information

• First Submitted Date: September 29, 2021
• First Posted Date: October 13, 2021
• Last Update Posted Date: November 22, 2023
• Actual Study Start Date: November 15, 2021
• Estimated Primary Completion Date: August 31, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 12, 2021)

number of retrieved lymph nodes [ Time Frame: during operation ]

number of retrieved lymph nodes during operation

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 12, 2021)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Gastric Cancer
• Gastric Adenocarcinoma

Intervention

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

Study Arms

Experimental: Single port or reduced ports

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

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

Publications *

• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 18, 2022): 108
• Original Estimated Enrollment (submitted: October 12, 2021): 130
• Estimated Study Completion Date: August 31, 2026
• Estimated Primary Completion Date: August 31, 2025 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT05076279
• Other Study ID Numbers: B-2107-696-001
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Yun-Suhk Suh, Seoul National University Bundang Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Seoul National University Bundang Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Seoul National University Bundang Hospital
• Verification Date: November 2023