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History of Changes for Study: NCT02751086
Robotic, Laparoscopic and Open Gastrectomy Compared on Short and Long Term Outcomes (IMIGASTRICII)
Latest version (submitted April 18, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 21, 2016 None (earliest Version on record)
2 August 15, 2017 Study Status and Outcome Measures
3 April 18, 2019 Study Status
Comparison Format:
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Study NCT02751086
Submitted Date:  April 21, 2016 (v1)
Open or close this module Study Identification
Unique Protocol ID: 002
Brief Title: Robotic, Laparoscopic and Open Gastrectomy Compared on Short and Long Term Outcomes (IMIGASTRICII)
Official Title: Prospective, Observational, Multicenter Study on Minimally Invasive Gastrectomy for Gastric Cancer: Robotic, Laparoscopic and Open Surgery Compared on Operative and Follow-up Outcomes
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2016
Overall Status: Recruiting
Study Start: April 2016
Primary Completion: May 2019 [Anticipated]
Study Completion: December 2024 [Anticipated]
First Submitted: April 10, 2016
First Submitted that
Met QC Criteria:		 April 21, 2016
First Posted: April 26, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:		 April 21, 2016
Last Update Posted: April 26, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: International Study Group on Minimally Invasive Surgery for Gastric Cancer
Responsible Party: Principal Investigator
Investigator: Amilcare Parisi
Official Title: Principal Investigator
Affiliation: International Study Group on Minimally Invasive Surgery for Gastric Cancer
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary:

The overall purpose is to develop and maintain a multi-institutional database comprising of information regarding surgical, clinical and oncological features of patients that will be treated for gastric cancer with robotic, laparoscopic or open approaches and subsequent follow-up.

The main objective is to compare the three surgical arms on surgical and clinical outcomes, as well as on the oncological follow-up.
Detailed Description:

A review of the scientific literature, which was recently published by the IMIGASTRIC study group, aimed to perform a more complete analysis of the current situation regarding performing minimally invasive surgery for gastric cancer. Significant limitations were found in the analyzed studies, including:

  • 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.
Open or close this module Conditions
Conditions: Gastric Cancer
Keywords: minimally invasive surgery
gastrectomy
robotic surgery
laparoscopic surgery
laparoscopy
robot-assisted
robotic
robotic gastrectomy
laparoscopic gastrectomy
minimally invasive gastrectomy
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 5000 [Anticipated]
Number of Groups/Cohorts 3
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
Robotic Gastrectomy
Patients who will be treated for gastric cancer with the assistance of the robotic surgical system
 Procedure: 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.
 Procedure: Laparoscopic Gastrectomy
Minimally invasive surgical approach performed through traditional laparoscopy.
Open Gastrectomy
Patients who will be treated for gastric cancer with traditional open surgery.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Rate of patients with intraoperative adverse events
[ Time Frame: During surgery ]
2. Mean of retrieved lymph nodes
[ Time Frame: Within 30 days after surgery ]

Count of retrieved lymph nodes at the histopathological examination of the surgical specimen
3. Rate of patients alive
[ Time Frame: 1 year after surgery ]
4. Rate of patients alive
[ Time Frame: 2 year after surgery ]
5. Rate of patients alive
[ Time Frame: 3 year after surgery ]
6. Rate of patients alive
[ Time Frame: 4 year after surgery ]
7. Rate of patients alive
[ Time Frame: 5 year after surgery ]
Secondary Outcome Measures:
1. Mean post-operative hospital stay
[ Time Frame: from the day after surgery to patient discharge, assessed up to 90 days ]
2. Rate of complications after discharge
[ Time Frame: 5 year after surgery ]
Open or close this module Eligibility
Study Population: Subjects with gastric cancer eligible for curative surgery.
Sampling Method: Probability Sample
Minimum Age: 18 Years
Maximum Age: 90 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Histologically proven gastric cancer
  • 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:

  • Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, Krukenberg tumors, involvement of other organs
  • 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
Open or close this module Contacts/Locations
Central Contact Person: Jacopo Desiderio, MD
Telephone: +393497531121
Email: djdesi85@hotmail.it
Study Officials: Amilcare Parisi, MD
Principal Investigator
St. Mary's Hospital of Terni
Locations: Italy
Department of Digestive Surgery, St. Mary's Hospital, University of Perugia
[Recruiting]
Terni, Italy, 05100
Contact:Contact: Amilcare Parisi amilcareparisi@virgilio.it
Contact:Contact: Jacopo Desiderio djdesi85@hotmail.it
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Citations: 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. PubMed 25758348
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. PubMed 25633739
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. PubMed 26482769
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. PubMed 24156033
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. PubMed 22330034
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. PubMed 21573742
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. PubMed 21573743
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. PubMed 19638912
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. PubMed 24685156
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. PubMed 20882416
Links: Description: Study's website. The study is open to other interested Institutions.
Available IPD/Information: Type: Study Protocol, study information, news
URL: http://www.imigastric.com Exit Disclaimer; please review our Privacy Policy

The study is open to other interested Institutions.

Correspondance to:

Jacopo Desiderio, MD djdesi85@hotmail.it
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