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

Eunju Lee, M.D.

YunSuhk Suh, M.D., Ph.D.

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

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.

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

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

number of retrieved lymph nodes during operation

Postoperative complications are problems that can happen after participants have had surgery but which were not intended.

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.

Seoul National University Bundang Hospital

Professor

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

Single-port

Multi-port

Jun-Gi Kim, MD

This clinical trial is going to compare the single-port and multi-port laparoscopic colectomy for colon cancer treatment, in terms of safety, efficacy, and cost.

The investigators hypothesize that the single-port laparoscopic colectomy is not inferior to multiport laparoscopic colectomy.

This clinical trial is a multicenter prospective randomized trial to compare the single-port and multi-port laparoscopic colectomy for colon cancer treatment.

Multicenter Single-port Colectomy RCT

A Multicenter Prospective Randomized Clinical Trail on the Efficacy of the Single Port Laparoscopic Surgery Compared With Multiport Laparoscopic Surgery

Kyunghee University

Chonnam National University

The Catholic University of Korea

MD, PhD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety and Efficacy of Single or Reduced Ports Laparoscopic Gastrectomy for Advanced Gastric Cancer (SPACE-01)	NCT05076279	Gastric Cancer Gastric Adenoca...	Single port or ...	19 Years - 80 Years	Seoul National University Bundang Hospital
Multicenter Single-port Colectomy RCT	NCT01480128	Colon Neoplasms	Single-port Multi-port	20 Years - 85 Years	The Catholic University of Korea

Spots Global Cancer Trial Database for single port

Every month we try and update this database with for single port cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for single port

Every month we try and update this database with for single port cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for single port cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.