Gastric Cancer Patients Undergoing Minimally Invasive Gastrectomy Clinical Trial
Official title:
Prospective Comparison of Surgical Outcomes With Using Integrated Robotic Technology Versus Conventional Laparoscopy for Gastric Cancer Surgery
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.
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.
| Status | Recruiting |
| Enrollment | 140 |
| Est. completion date | December 25, 2023 |
| Est. primary completion date | December 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 70 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Severance hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of retrieved LN | during the gastrectomy surgery |