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Prospective Comparison of Surgical Outcomes With Using Integrated Robotic Technology Versus Conventional Laparoscopy for Gastric Cancer Surgery

Primary Purpose

Gastric Cancer Patients Undergoing Minimally Invasive Gastrectomy

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Integrated robotic surgery
Conventional laparoscopic surgery
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer Patients Undergoing Minimally Invasive Gastrectomy

Eligibility Criteria

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

Inclusion Criteria:

  • Documented diagnosis of gastric adenocarcinoma and scheduled to undergo minimally invasive gastrectomy
  • Age > 20 years
  • A patient who signed the informed consent

Exclusion Criteria:

  • Mentally incompetent, illiterate, or pregnant patients
  • Requiring major combined resection (colon, pancreas, etc., except the gall bladder)
  • Having metastatic or non-resectable lesion.
  • Active other cancer history

Sites / Locations

  • Severance hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Integrated robotic surgery

Conventional laparoscopic surgery

Arm Description

Outcomes

Primary Outcome Measures

Number of retrieved LN

Secondary Outcome Measures

Full Information

First Posted
January 4, 2018
Last Updated
September 28, 2020
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT03396354
Brief Title
Prospective Comparison of Surgical Outcomes With Using Integrated Robotic Technology Versus Conventional Laparoscopy for Gastric Cancer Surgery
Official Title
Prospective Comparison of Surgical Outcomes With Using Integrated Robotic Technology Versus Conventional Laparoscopy for Gastric Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Despite the theoretical superiority of robotic technology, surgical outcomes following robotic surgery have shown little benefit over conventional laparoscopic surgery. At present, studies have evaluated the value of robotic technology in clinical practice, including EndoWrist®, TilePro®, Firefly®, and Single-Site®, and have demonstrated the possibility of added clinical value, specifically in regards to decreased postoperative pancreatic fistula, usefulness as a multi-display education system, visualization of lymphatic channels, and implementation of reduced-port robotic gastrectomy. However, these technologies have only been applied independently and not in a well-organized manner. Maximizing radicality and safety while minimizing invasiveness are critical to bettering cancer surgery. We hypothesize that robot technology can affect these factors positively and that the use of appropriate parameters thereof could help shed more light on the benefits of a robotic system in gastric cancer surgery. Radicality: added benefit of Firefly® for lymph node visualization Number of retrieved lymph nodes can be considered a surrogate marker of long-term survival. In our proposed study, we will focus on the number of retrieved (lymph nodes as the primary outcome. Additionally, bleeding, which is known to be associated with poor overall survival, will be measured as a secondary outcome. Three-year recurrence free survival and 5-year overall survival will be followed up. Safety: benefit of Firefly® in differentiating lymph nodes from other organs and benefit of a magnified view and EndoWrist® Although robotic surgery reportedly shows less in-hospital and outpatient complication rates, a higher number of enrolled patients is needed to statistically validate these results. In the currently proposed study, these would be secondary outcomes. We have experienced the benefit of using fluorescence imaging to differentiate lymph node from biliary trees and pancreas parenchyma. As a reflection thereof, bleeding would be measured as parameter of unintended injury to a normal organ. To evaluate injury to pancreas parenchyma and postoperative pancreatic fistula, amylase/lipase levels in serum and drainage fluid will be measured. Invasiveness: value of Single-Site® Serum CRP (C reactive protein) levels (day 0, day 3, day 5, and 4 weeks after surgery) and pain scores (at 6 hr, 12 hr, 24 hr, 48 hr, and 72 hr after surgery) will be measured to evaluate surgical trauma to the patients. Satisfaction on the wound will be evaluated using Korean version of the body image scale at one month after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer Patients Undergoing Minimally Invasive Gastrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Integrated robotic surgery
Arm Type
Experimental
Arm Title
Conventional laparoscopic surgery
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Integrated robotic surgery
Intervention Description
Robotic gastrectomy using Single-Site and Firefly technology will be performed. Specifically, two-port surgery using the Single-Site port and an independent trocar along the right flank (for harmonic scalpel) will be used, along with peritumoral injection of indocyanine green via endoscopy the day before surgery to completely visualize the entire lymphatic channel.
Intervention Type
Procedure
Intervention Name(s)
Conventional laparoscopic surgery
Intervention Description
conventional laparoscopic gastrectomy will be performed.
Primary Outcome Measure Information:
Title
Number of retrieved LN
Time Frame
during the gastrectomy surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented diagnosis of gastric adenocarcinoma and scheduled to undergo minimally invasive gastrectomy Age > 20 years A patient who signed the informed consent Exclusion Criteria: Mentally incompetent, illiterate, or pregnant patients Requiring major combined resection (colon, pancreas, etc., except the gall bladder) Having metastatic or non-resectable lesion. Active other cancer history
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyoung-Il Kim
Phone
+82-2-2228-2100
Email
cairus@yuhs.ac
Facility Information:
Facility Name
Severance hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyoung Il Kim, MD, PhD
Phone
82-2-2228-2139
Email
cairus@yuhs.ac

12. IPD Sharing Statement

Citations:
PubMed Identifier
26020107
Citation
Kim HI, Han SU, Yang HK, Kim YW, Lee HJ, Ryu KW, Park JM, An JY, Kim MC, Park S, Song KY, Oh SJ, Kong SH, Suh BJ, Yang DH, Ha TK, Kim YN, Hyung WJ. Multicenter Prospective Comparative Study of Robotic Versus Laparoscopic Gastrectomy for Gastric Adenocarcinoma. Ann Surg. 2016 Jan;263(1):103-9. doi: 10.1097/SLA.0000000000001249.
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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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
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
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
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
28205030
Citation
Lee S, Kim JK, Kim YN, Jang DS, Kim YM, Son T, Hyung WJ, Kim HI. Safety and feasibility of reduced-port robotic distal gastrectomy for gastric cancer: a phase I/II clinical trial. Surg Endosc. 2017 Oct;31(10):4002-4009. doi: 10.1007/s00464-017-5435-y. Epub 2017 Feb 15.
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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Prospective Comparison of Surgical Outcomes With Using Integrated Robotic Technology Versus Conventional Laparoscopy for Gastric Cancer Surgery

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