Prospective Comparison of Surgical Outcomes With Using Integrated Robotic Technology Versus Conventional Laparoscopy for Gastric Cancer Surgery
NCT ID: NCT03396354
Last Updated: 2020-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
140 participants
INTERVENTIONAL
2018-01-02
2023-12-25
Brief Summary
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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.
1. 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.
2. 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.
3. 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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Integrated robotic surgery
Integrated robotic surgery
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.
Conventional laparoscopic surgery
Conventional laparoscopic surgery
conventional laparoscopic gastrectomy will be performed.
Interventions
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Integrated robotic surgery
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.
Conventional laparoscopic surgery
conventional laparoscopic gastrectomy will be performed.
Eligibility Criteria
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Inclusion Criteria
* Age \> 20 years
* A patient who signed the informed consent
Exclusion Criteria
* Requiring major combined resection (colon, pancreas, etc., except the gall bladder)
* Having metastatic or non-resectable lesion.
* Active other cancer history
20 Years
70 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Severance hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Kitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994 Apr;4(2):146-8.
Choi S, Kim NY, Kim YN, Park SH, Kim KY, Cho M, Kim YM, Hyung WJ, Kim HI. Fluorescence-guided Two-port Robotic Gastrectomy Versus Conventional Laparoscopic Gastrectomy: A Nonrandomized Controlled Trial. Ann Surg Open. 2023 Jul 26;4(3):e318. doi: 10.1097/AS9.0000000000000318. eCollection 2023 Sep.
Other Identifiers
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4-2017-1066
Identifier Type: -
Identifier Source: org_study_id
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