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

Gastric Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02751086
• Other study ID #: 002
• Status: Recruiting
• Start date: April 2016
• Est. completion date: December 2024

Study information

• Verified date: April 2019
• Source: International Study Group on Minimally Invasive Surgery for Gastric Cancer
• Contact: Jacopo Desiderio, MD
• Phone: +393497531121
• Email: djdesi85[@]hotmail.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 2024
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

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

Locations

Country	Name	City	State
Italy	Department of Digestive Surgery, St. Mary's Hospital, University of Perugia	Terni

Sponsors (1)

Lead Sponsor	Collaborator
International Study Group on Minimally Invasive Surgery for Gastric Cancer

Country where clinical trial is conducted

Italy, 

References & Publications (10)

Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibañes 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Viñuela 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients with intraoperative adverse events	events other than the normal course of the surgery	During surgery
Primary	Mean of retrieved lymph nodes	Count of retrieved lymph nodes at the histopathological examination of the surgical specimen	Within 30 days after surgery
Primary	Rate of patients alive	subjects alive at the planned endpoint	1 year after surgery
Primary	Rate of patients alive	subjects alive at the planned endpoint	2 year after surgery
Primary	Rate of patients alive	subjects alive at the planned endpoint	3 year after surgery
Primary	Rate of patients alive	subjects alive at the planned endpoint	4 year after surgery
Primary	Rate of patients alive	subjects alive at the planned endpoint	5 year after surgery
Secondary	Mean post-operative hospital stay	hospital stay of the patients after surgery	from the day after surgery to patient discharge, assessed up to 90 days
Secondary	Rate of complications after discharge	any surgical related event after patient's discharge	5 year after surgery

External Links

•   Study's website. The study is open to other interested Institutions.