Robotic, Laparoscopic and Open Gastrectomy Compared on Short and Long Term Outcomes
NCT ID: NCT02751086
Last Updated: 2019-04-22
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
5000 participants
OBSERVATIONAL
2016-04-30
2024-12-31
Brief Summary
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The main objective is to compare the three surgical arms on surgical and clinical outcomes, as well as on the oncological follow-up.
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Detailed Description
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* Small samples of patients, mostly low-quality comparative studies
* Selection bias in the comparison groups (e.g. stage, extent of lymphadenectomy)
* Absence of subgroup analysis in significant research fields
* Lack of information on the surgical techniques adopted
A large prospective multicenter registry could thus be the optimal way to clarify the role of minimally invasive surgery for gastric cancer and permit the evaluation of its short and long-term effects. A working basis for analyzing outcomes of interest and obtaining directions for guidelines and future study developments can also be created. The following would be the main advantages of a large prospective multicenter registry:
* Achieving a large sample of patients
* Collecting multiple variables, allowing for the making of a comprehensive statistical report
* Standardizing the methodology to be adopted, thus increasing accuracy
* Bringing together the experiences of both East and West to discover shared points A prospective registry can become a powerful tool that can guide research in this field to new developments and pave the way for other investigational opportunities.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Robotic Gastrectomy
Patients who will be treated for gastric cancer with the assistance of the robotic surgical system
Robotic Gastrectomy
Minimally invasive surgical approach, related to the availability of a robotic surgical system (eg Da Vinci surgical system), that allows a surgeon to perform surgery through a console and dedicated devices.
Laparoscopic Gastrectomy
Patients who will be treated for gastric cancer through laparoscopic devices.
Laparoscopic Gastrectomy
Minimally invasive surgical approach performed through traditional laparoscopy.
Open Gastrectomy
Patients who will be treated for gastric cancer with traditional open surgery.
No interventions assigned to this group
Interventions
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Robotic Gastrectomy
Minimally invasive surgical approach, related to the availability of a robotic surgical system (eg Da Vinci surgical system), that allows a surgeon to perform surgery through a console and dedicated devices.
Laparoscopic Gastrectomy
Minimally invasive surgical approach performed through traditional laparoscopy.
Eligibility Criteria
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Inclusion Criteria
* Preoperative staging work-up performed by upper endoscopy and/or endoscopic ultrasound, and CT scan and in accordance to international guidelines
* Early Gastric Cancer
* Advanced Gastric Cancer
* Patients treated with curative intent in accordance to international guidelines
Exclusion Criteria
* Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score \> 4
* History of previous abdominal surgery for gastric cancer
* Synchronous malignancy in other organs
* Palliative surgery
18 Years
90 Years
ALL
No
Sponsors
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International Study Group on Minimally Invasive Surgery for Gastric Cancer
OTHER
Responsible Party
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Amilcare Parisi
Principal Investigator
Principal Investigators
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Amilcare Parisi, MD
Role: PRINCIPAL_INVESTIGATOR
St. Mary's Hospital of Terni
Locations
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Department of Digestive Surgery, St. Mary's Hospital, University of Perugia
Terni, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Parisi A, Nguyen NT, Reim D, Zhang S, Jiang ZW, Brower ST, Azagra JS, Facy O, Alimoglu O, Jackson PG, Tsujimoto H, Kurokawa Y, Zang L, Coburn NG, Yu PW, Zhang B, Qi F, Coratti A, Annecchiarico M, Novotny A, Goergen M, Lequeu JB, Eren T, Leblebici M, Al-Refaie W, Takiguchi S, Ma J, Zhao YL, Liu T, Desiderio J. Current status of minimally invasive surgery for gastric cancer: A literature review to highlight studies limits. Int J Surg. 2015 May;17:34-40. doi: 10.1016/j.ijsu.2015.02.021. Epub 2015 Mar 7.
Parisi A, Desiderio J. Establishing a multi-institutional registry to compare the outcomes of robotic, laparoscopic, and open surgery for gastric cancer. Surgery. 2015 Apr;157(4):830-1. doi: 10.1016/j.surg.2014.12.007. Epub 2015 Jan 26. No abstract available.
Desiderio J, Jiang ZW, Nguyen NT, Zhang S, Reim D, Alimoglu O, Azagra JS, Yu PW, Coburn NG, Qi F, Jackson PG, Zang L, Brower ST, Kurokawa Y, Facy O, Tsujimoto H, Coratti A, Annecchiarico M, Bazzocchi F, Avanzolini A, Gagniere J, Pezet D, Cianchi F, Badii B, Novotny A, Eren T, Leblebici M, Goergen M, Zhang B, Zhao YL, Liu T, Al-Refaie W, Ma J, Takiguchi S, Lequeu JB, Trastulli S, Parisi A. Robotic, laparoscopic and open surgery for gastric cancer compared on surgical, clinical and oncological outcomes: a multi-institutional chart review. A study protocol of the International study group on Minimally Invasive surgery for GASTRIc Cancer-IMIGASTRIC. BMJ Open. 2015 Oct 19;5(10):e008198. doi: 10.1136/bmjopen-2015-008198.
Marano A, Choi YY, Hyung WJ, Kim YM, Kim J, Noh SH. Robotic versus Laparoscopic versus Open Gastrectomy: A Meta-Analysis. J Gastric Cancer. 2013 Sep;13(3):136-48. doi: 10.5230/jgc.2013.13.3.136. Epub 2013 Sep 30.
Vinuela EF, Gonen M, Brennan MF, Coit DG, Strong VE. Laparoscopic versus open distal gastrectomy for gastric cancer: a meta-analysis of randomized controlled trials and high-quality nonrandomized studies. Ann Surg. 2012 Mar;255(3):446-56. doi: 10.1097/SLA.0b013e31824682f4.
Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2010 (ver. 3). Gastric Cancer. 2011 Jun;14(2):113-23. doi: 10.1007/s10120-011-0042-4. No abstract available.
Japanese Gastric Cancer Association. Japanese classification of gastric carcinoma: 3rd English edition. Gastric Cancer. 2011 Jun;14(2):101-12. doi: 10.1007/s10120-011-0041-5. No abstract available.
Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
Waddell T, Verheij M, Allum W, Cunningham D, Cervantes A, Arnold D. Gastric cancer: ESMO-ESSO-ESTRO clinical practice guidelines for diagnosis, treatment and follow-up. Eur J Surg Oncol. 2014 May;40(5):584-591. doi: 10.1016/j.ejso.2013.09.020. No abstract available.
Washington K. 7th edition of the AJCC cancer staging manual: stomach. Ann Surg Oncol. 2010 Dec;17(12):3077-9. doi: 10.1245/s10434-010-1362-z. No abstract available.
Study Documents
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Document Type: Study Protocol, study information, news
The study is open to other interested Institutions. Correspondance to: Jacopo Desiderio, MD [email protected]
View DocumentRelated Links
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Study's website. The study is open to other interested Institutions.
Other Identifiers
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002
Identifier Type: -
Identifier Source: org_study_id
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