Gastric Cancer Patients Undergoing Minimally Invasive GastrectomyNCT03396354
Prospective Comparison of Surgical Outcomes With Using Integrated Robotic Technology Versus Conventional Laparoscopy for Gastric Cancer Surgery
A study testing Integrated robotic surgery and Conventional laparoscopic surgery in people with Gastric Cancer Patients Undergoing Minimally Invasive Gastrectomy, run by Yonsei University at 1 site in South Korea.
Trial 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®… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Gastric Cancer Patients Undergoing Minimally Invasive Gastrectomy
- What is being tested?
- Integrated robotic surgery and Conventional laparoscopic surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jan 2018to 25 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented diagnosis of gastric adenocarcinoma and scheduled to undergo minimally invasive gastrectomy
- Age > 20 years
- A patient who signed the informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance hospital
Seoul, 120-752
Hyoung Il Kim, MD, PhD, 82-2-2228-2139, cairus@yuhs.ac
About this study
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.
- Being tested
- Integrated robotic surgery, Conventional laparoscopic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated robotic surgeryProcedure or 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 surgeryProcedure or surgery
conventional laparoscopic gastrectomy will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Integrated robotic surgery | Experimental | Not described Receives: Procedure: Integrated robotic surgery |
| Conventional laparoscopic surgery | Active comparator | Not described Receives: Procedure: Conventional laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of retrieved LN
Measured: during the gastrectomy surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start2 Jan 2018
- Primary completionDec 2023 (estimated)
- Study completion25 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Gastric Cancer Patients Undergoing Minimally Invasive GastrectomyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396354
- Sponsor's protocol ID
- 4-2017-1066
- Status last verified
- Sep 2020
- First submitted
- 4 Jan 2018
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26020107Zeng 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.
PubMed 22664559Vizza 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.
PubMed 23468046Kim 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.
PubMed 20160637Pietrabissa 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.
PubMed 22508669Kim 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.
PubMed 23207683Lee 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.
PubMed 28205030Kitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994 Apr;4(2):146-8.
PubMed 8180768Choi 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.
PubMed 37746613
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of Surgical Outcomes With Using Integrated Robotic Technology Versus Conventional Laparoscopy for Gastric Cancer Surgery
- ClinicalTrials.gov ID
- NCT03396354
- Acronym / sponsor ID
- 4-2017-1066
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- 25 Dec 2023 (estimated)
- First posted
- 10 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated robotic surgery | Experimental | Procedure: Integrated robotic surgery |
| Conventional laparoscopic surgery | Active comparator | Procedure: Conventional laparoscopic surgery |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Documented diagnosis of gastric adenocarcinoma and scheduled to undergo minimally invasive gastrectomy
- Age > 20 years
- A patient who signed the informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated robotic surgeryRobotic 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. | Procedure or surgery | Integrated robotic surgery |
| Conventional laparoscopic surgeryconventional laparoscopic gastrectomy will be performed. | Procedure or surgery | Conventional laparoscopic surgery |
Primary outcome
Number of retrieved LN
Time frame: during the gastrectomy surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Background: PubMed 26020107Kim 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.
- Background: PubMed 22664559Zeng 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.
- Background: PubMed 23468046Vizza 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.
- Background: PubMed 20160637Kim 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.
- Background: PubMed 22508669Pietrabissa 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.
- Background: PubMed 23207683Kim 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.
- Background: PubMed 28205030Lee 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.
- Background: PubMed 8180768Kitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994 Apr;4(2):146-8.
- Derived from this study: PubMed 37746613Choi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated robotic surgery and Conventional laparoscopic surgery in people with Gastric Cancer Patients Undergoing Minimally Invasive Gastrectomy, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyoung-Il Kim (+82-2-2228-2100, cairus@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of retrieved LN (time frame: during the gastrectomy surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03396354, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2020.