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The Safety and Feasibility of Reduced Port Robotic Distal Gastrectomy Using Single-site for Surgical Treatment of Early Gastric Cancer

Primary Purpose

Gastric Cancer

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Reduced port robotic distal gastrectomy

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring robot surgery, reduced port, single-site, safety, feasibility

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

A resectable, tissue confirmed adenocarcinoma of the stomach
Early gastric cancer curable by distal gastrectomy
AGE: 20-70
ECOG: 0-1
ASA score 1-3
A patient who signed the informed consent

Exclusion Criteria:

Advanced lesion with metastatic cancer
lesion which is curable by EMR or ESD
Previous major abdominal surgery
Complicated gastric cancer (obstruction or perforation)
History with other primary tumor within 5 year
Active other primary tumor
Vulnerable subjects (pregnant women, illiterate)

Sites / Locations

Severance hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Reduced port group

Arm Description

Outcomes

Primary Outcome Measures

morbidity

Secondary Outcome Measures

mortality

Full Information

NCT ID

NCT02347956

First Posted

January 20, 2015

Last Updated

November 12, 2015

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02347956

Brief Title

The Safety and Feasibility of Reduced Port Robotic Distal Gastrectomy Using Single-site for Surgical Treatment of Early Gastric Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Gastric cancer is one of the most common malignancy worldwide. Surgical resection of the tumor is the only curative treatment for gastric cancer. However, surgical procedure accompanies postoperative pain and prolonged hospitalization. To lessen the surgical trauma and stress, minimally invasive surgery were introduced. Laparoscopic gastrectomy was accepted as safe and effective alternative to open gastrectomy. Furthermore, reduced port and single port laparoscopic gastrectomy are considered to minimize the surgical trauma during gastrectomy. However, limitations of laparoscopic approach using reduced port includes unergonomic posture of surgeon, physiologic tremor and collision of instruments. To overcome these limitations, robot surgery using novel single-site technology enabled surgeons to perform the surgical procedure reducing the number of trocar from three to one for insertion of scope and two robotic arms. Previously, successful application of single-site technology for cholecystectomy and hysterectomy were reported. The aim of this study is to validate the safety and feasibility of reduced port robotic distal gastrectomy using single-site technology for the surgical treatment of gastric cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

robot surgery, reduced port, single-site, safety, feasibility

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Reduced port group

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Reduced port robotic distal gastrectomy

Primary Outcome Measure Information:

Title

morbidity

Time Frame

30 days

Secondary Outcome Measure Information:

Title

mortality

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: A resectable, tissue confirmed adenocarcinoma of the stomach Early gastric cancer curable by distal gastrectomy AGE: 20-70 ECOG: 0-1 ASA score 1-3 A patient who signed the informed consent Exclusion Criteria: Advanced lesion with metastatic cancer lesion which is curable by EMR or ESD Previous major abdominal surgery Complicated gastric cancer (obstruction or perforation) History with other primary tumor within 5 year Active other primary tumor Vulnerable subjects (pregnant women, illiterate)

Facility Information:

Facility Name

Severance hospital

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

22076206

Citation

Jeong O, Park YK. Clinicopathological features and surgical treatment of gastric cancer in South Korea: the results of 2009 nationwide survey on surgically treated gastric cancer patients. J Gastric Cancer. 2011 Jun;11(2):69-77. doi: 10.5230/jgc.2011.11.2.69. Epub 2011 Jun 30.

Results Reference

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PubMed Identifier

20160637

Citation

Kim HH, Hyung WJ, Cho GS, Kim MC, Han SU, Kim W, Ryu SW, Lee HJ, Song KY. Morbidity and mortality of laparoscopic gastrectomy versus open gastrectomy for gastric cancer: an interim report--a phase III multicenter, prospective, randomized Trial (KLASS Trial). Ann Surg. 2010 Mar;251(3):417-20. doi: 10.1097/SLA.0b013e3181cc8f6b.

Results Reference

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PubMed Identifier

23207683

Citation

Kim YM, Baek SE, Lim JS, Hyung WJ. Clinical application of image-enhanced minimally invasive robotic surgery for gastric cancer: a prospective observational study. J Gastrointest Surg. 2013 Feb;17(2):304-12. doi: 10.1007/s11605-012-2094-0. Epub 2012 Dec 1.

Results Reference

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PubMed Identifier

8180768

Citation

Kitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994 Apr;4(2):146-8. Erratum In: Surg Laparosc Endosc. 2013 Oct;23(5):480.

Results Reference

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PubMed Identifier

22318810

Citation

Lee JH, Kim KM, Cheong JH, Noh SH. Current management and future strategies of gastric cancer. Yonsei Med J. 2012 Mar;53(2):248-57. doi: 10.3349/ymj.2012.53.2.248.

Results Reference

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PubMed Identifier

22508669

Citation

Pietrabissa A, Sbrana F, Morelli L, Badessi F, Pugliese L, Vinci A, Klersy C, Spinoglio G. Overcoming the challenges of single-incision cholecystectomy with robotic single-site technology. Arch Surg. 2012 Aug;147(8):709-14. doi: 10.1001/archsurg.2012.508.

Results Reference

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PubMed Identifier

24005955

Citation

Tokunaga M, Sugisawa N, Kondo J, Tanizawa Y, Bando E, Kawamura T, Terashima M. Early phase II study of robot-assisted distal gastrectomy with nodal dissection for clinical stage IA gastric cancer. Gastric Cancer. 2014;17(3):542-7. doi: 10.1007/s10120-013-0293-3. Epub 2013 Sep 5.

Results Reference

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PubMed Identifier

23468046

Citation

Vizza E, Corrado G, Mancini E, Baiocco E, Patrizi L, Fabrizi L, Colantonio L, Cimino M, Sindico S, Forastiere E. Robotic single-site hysterectomy in low risk endometrial cancer: a pilot study. Ann Surg Oncol. 2013 Aug;20(8):2759-64. doi: 10.1245/s10434-013-2922-9. Epub 2013 Mar 7.

Results Reference

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PubMed Identifier

22664559

Citation

Zeng YK, Yang ZL, Peng JS, Lin HS, Cai L. Laparoscopy-assisted versus open distal gastrectomy for early gastric cancer: evidence from randomized and nonrandomized clinical trials. Ann Surg. 2012 Jul;256(1):39-52. doi: 10.1097/SLA.0b013e3182583e2e.

Results Reference

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The Safety and Feasibility of Reduced Port Robotic Distal Gastrectomy Using Single-site for Surgical Treatment of Early Gastric Cancer

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