Robotic, Laparoscopic and Open Gastrectomy Compared on Short and Long Term Outcomes (IMIGASTRICII)

• ClinicalTrials.gov Identifier: NCT02751086
• Recruitment Status: Recruiting
• First Posted: April 26, 2016
• Last Update Posted: April 22, 2019
• Sponsor: International Study Group on Minimally Invasive Surgery for Gastric Cancer
• Information provided by (Responsible Party): Amilcare Parisi, International Study Group on Minimally Invasive Surgery for Gastric Cancer

Tracking Information

• First Submitted Date: April 10, 2016
• First Posted Date: April 26, 2016
• Last Update Posted Date: April 22, 2019
• Study Start Date: April 2016
• Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 15, 2017)

• Rate of patients with intraoperative adverse events [ Time Frame: During surgery ]
  events other than the normal course of the surgery
• 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
• Rate of patients alive [ Time Frame: 1 year after surgery ]
  subjects alive at the planned endpoint
• Rate of patients alive [ Time Frame: 2 year after surgery ]
  subjects alive at the planned endpoint
• Rate of patients alive [ Time Frame: 3 year after surgery ]
  subjects alive at the planned endpoint
• Rate of patients alive [ Time Frame: 4 year after surgery ]
  subjects alive at the planned endpoint
• Rate of patients alive [ Time Frame: 5 year after surgery ]
  subjects alive at the planned endpoint

Original Primary Outcome Measures (submitted: April 21, 2016)

• Rate of patients with intraoperative adverse events [ Time Frame: During surgery ]
• 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
• Rate of patients alive [ Time Frame: 1 year after surgery ]
• Rate of patients alive [ Time Frame: 2 year after surgery ]
• Rate of patients alive [ Time Frame: 3 year after surgery ]
• Rate of patients alive [ Time Frame: 4 year after surgery ]
• Rate of patients alive [ Time Frame: 5 year after surgery ]

Current Secondary Outcome Measures (submitted: August 15, 2017)

• Mean post-operative hospital stay [ Time Frame: from the day after surgery to patient discharge, assessed up to 90 days ]
  hospital stay of the patients after surgery
• Rate of complications after discharge [ Time Frame: 5 year after surgery ]
  any surgical related event after patient's discharge

Original Secondary Outcome Measures (submitted: April 21, 2016)

• Mean post-operative hospital stay [ Time Frame: from the day after surgery to patient discharge, assessed up to 90 days ]
• Rate of complications after discharge [ Time Frame: 5 year after surgery ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Robotic, Laparoscopic and Open Gastrectomy Compared on Short and Long Term Outcomes
• 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

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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Subjects with gastric cancer eligible for curative surgery.
• Condition: Gastric Cancer

Intervention

• 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.
• Procedure: Laparoscopic Gastrectomy
  Minimally invasive surgical approach performed through traditional laparoscopy.

Study Groups/Cohorts

• Robotic Gastrectomy
  Patients who will be treated for gastric cancer with the assistance of the robotic surgical system
  Intervention: Procedure: Robotic Gastrectomy
• Laparoscopic Gastrectomy
  Patients who will be treated for gastric cancer through laparoscopic devices.
  Intervention: Procedure: Laparoscopic Gastrectomy
• Open Gastrectomy
  Patients who will be treated for gastric cancer with traditional open surgery.

Publications *

• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 21, 2016): 5000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2024
• Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Jacopo Desiderio, MD; +393497531121; djdesi85@hotmail.it

• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT02751086
• Other Study ID Numbers: 002
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Amilcare Parisi, International Study Group on Minimally Invasive Surgery for Gastric Cancer
• Original Responsible Party: Same as current
• Current Study Sponsor: International Study Group on Minimally Invasive Surgery for Gastric Cancer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Amilcare Parisi, MD; St. Mary's Hospital of Terni

• PRS Account: International Study Group on Minimally Invasive Surgery for Gastric Cancer
• Verification Date: April 2019