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

NCT02751086 | Unknown DMC

• 1 other identifier: 002
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

minimally invasive surgery; gastrectomy; robotic surgery; laparoscopic surgery; laparoscopy; robot-assisted; robotic; robotic gastrectomy; laparoscopic gastrectomy; minimally invasive gastrectomy

Outcome Measures

Primary Outcomes (7)

• Rate of patients with intraoperative adverse events

  events other than the normal course of the surgery

  During surgery

• Mean of retrieved lymph nodes

  Count of retrieved lymph nodes at the histopathological examination of the surgical specimen

  Within 30 days after surgery

• Rate of patients alive

  subjects alive at the planned endpoint

  1 year after surgery

• Rate of patients alive

  subjects alive at the planned endpoint

  2 year after surgery

• Rate of patients alive

  subjects alive at the planned endpoint

  3 year after surgery

• Rate of patients alive

  subjects alive at the planned endpoint

  4 year after surgery

• Rate of patients alive

  subjects alive at the planned endpoint

  5 year after surgery

Secondary Outcomes (2)

• Mean post-operative hospital stay

  from the day after surgery to patient discharge, assessed up to 90 days

• Rate of complications after discharge

  5 year after surgery

Study Arms (3)

Robotic Gastrectomy

Patients who will be treated for gastric cancer with the assistance of the robotic surgical system

Procedure: Robotic Gastrectomy

Laparoscopic Gastrectomy

Patients who will be treated for gastric cancer through laparoscopic devices.

Procedure: Laparoscopic Gastrectomy

Open Gastrectomy

Patients who will be treated for gastric cancer with traditional open surgery.

Interventions

Robotic Gastrectomy PROCEDURE

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.

Robotic Gastrectomy

Laparoscopic Gastrectomy PROCEDURE

Minimally invasive surgical approach performed through traditional laparoscopy.

Laparoscopic Gastrectomy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with gastric cancer eligible for curative surgery.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Study Group on Minimally Invasive Surgery for Gastric Cancer: lead

Study Sites (1)

Department of Digestive Surgery, St. Mary's Hospital, University of Perugia

Terni, 05100, Italy

RECRUITING

Related Publications (10)

• 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.

  PMID: 25758348 BACKGROUND

• 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.

  PMID: 25633739 BACKGROUND

• 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.

  PMID: 26482769 BACKGROUND

• 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.

  PMID: 24156033 BACKGROUND

• 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.

  PMID: 22330034 BACKGROUND

• 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.

  PMID: 21573742 BACKGROUND

• 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.

  PMID: 21573743 BACKGROUND

• 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.

  PMID: 19638912 BACKGROUND

• 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.

  PMID: 24685156 BACKGROUND

• 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.

  PMID: 20882416 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Amilcare Parisi, MD

  St. Mary's Hospital of Terni

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacopo Desiderio, MD

CONTACT

+393497531121; djdesi85@hotmail.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 10, 2016
• First Posted: April 26, 2016
• Study Start: April 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: December 1, 2024
• Last Updated: April 22, 2019

Record last verified: 2019-04

Locations

IT (1)