NCT02325453

Brief Summary

Gastric cancer represents a great challenge for health care providers and requires a multidisciplinary context in which surgery plays a main role. Minimally invasive surgery has been progressively developed, first with the advent of laparoscopy and more recently with the spread of robotic systems, but a number of issues are currently being debated, including the limitations in performing effective extended lymph node dissections and, in this context, the real advantages of using the robotic systems, the possible role for the Advanced Gastric Cancer, the reproducibility of completely intracorporeal techniques and the oncological results achievable during follow-up. A multicenter study with a large number of patients is now needed to further investigate the safety and efficacy as well as long-term outcomes of robotic surgery, traditional laparoscopy and the open approach.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 25, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

April 22, 2019

Status Verified

April 1, 2019

Enrollment Period

4.7 years

First QC Date

December 16, 2014

Last Update Submit

April 18, 2019

Conditions

Gastric Cancer

Keywords

Robotic SurgeryLaparoscopic SurgeryMinimally Invasive SurgeryRobotic GastrectomyLaparoscopic GastrectomyOpen GastrectomyGastric Surgery

Outcome Measures

Primary Outcomes (6)

  • Compare robotic and laparoscopic surgery with the open approach in terms of safety and feasibility. (Intraoperative complications.)

    Intraoperative complications.

    Intraoperative.

  • Verify the respect of oncological principles through minimally invasive approaches in relation to the stage and location of the tumor by comparing results with open surgery. (Number of lymph nodes retrieved.)

    Number of lymph nodes retrieved.

    Intraoperative.

  • Compare the three treatment arms in terms of recovery of gastrointestinal functions and physical status allowing the discharge of the patient. (Days of hospitalization after surgery until discharge.)

    Days of hospitalization after surgery until discharge.

    Assessment during an average period of 10 days after surgery.

  • Compare the incidence, types and severity of early postoperative complications after gastrectomy by the three approaches. (Score based on the Clavien-Dindo classification system.)

    Score based on the Clavien-Dindo classification system.

    Assessment during an average period of 10 days after surgery.

  • Verify whether minimally invasive approaches ensure the same effectiveness than open surgery. (Overall survival.)

    Overall survival.

    Assessment at 1, 3, 5 years from surgery.

  • Compare the three treatment arms in terms of tumor recurrence after treatment. (Disease-free survival)

    Disease-free survival.

    Assessment at 1, 3, 5 years from surgery.

Secondary Outcomes (3)

  • Verify the safety of intracorporeal anastomosis in comparison with extracorporeal anastomosis. (Anastomotic leakage)

    Assessment during an average period of 10 days after surgery.

  • Compare the intracorporeal anastomosis with the extracorporeal anastomosis to evaluate post-operative recovery. (Days of hospitalization after surgery until discharge.)

    Assessment during an average period of 10 days after surgery.

  • Verify whether robotic gastrectomy, compared with laparoscopic or open techniques, is capable of improving postoperative surgical stress. (Granulocyte-to-lymphocyte ratio.)

    Assessment during an average period of 10 days after surgery.

Study Arms (3)

Robotic Surgery

Patients underwent gastric surgery through the use of a robotic system.

Procedure: Robotic Surgery

Laparoscopic Surgery

Patients underwent gastric surgery with laparoscopic procedures.

Procedure: Laparoscopic Surgery

Open Surgery

Patients underwent gastric surgery with open approach.

Procedure: Open Surgery

Interventions

Robotic SurgeryPROCEDURE

Surgical procedure performed with a robotic system.

Robotic Surgery
Laparoscopic SurgeryPROCEDURE

Surgical procedure performed with laparoscopic techniques.

Laparoscopic Surgery
Open SurgeryPROCEDURE

Traditional approach for gastric cancer.

Open Surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects undergoing surgery for gastric cancer with robotic, laparoscopic or open approaches and subsequent follow-up.

You may qualify if:

  • Histologically proven gastric cancer
  • Preoperative staging work-up performed by upper endoscopy / endoscopic ultrasound, and CT scan
  • Early Gastric Cancer
  • Advanced Gastric Cancer
  • Patients treated with curative intent in accordance to international guidelines

You may not qualify if:

  • Locally advanced tumor infiltrating neighboring organs
  • 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 gastric surgery
  • Remnant gastric cancer
  • Synchronous other major abdominal surgery
  • Synchronous malignancy in other organs
  • Palliative surgery cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Terni, 05100, Italy

RECRUITING

Related Publications (7)

  • 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: 22330034BACKGROUND

  • Alimoglu O, Atak I, Eren T. Robot-assisted laparoscopic (RAL) surgery for gastric cancer. Int J Med Robot. 2014 Sep;10(3):257-62. doi: 10.1002/rcs.1566. Epub 2013 Dec 23.

    PMID: 24375986BACKGROUND

  • Shen WS, Xi HQ, Chen L, Wei B. A meta-analysis of robotic versus laparoscopic gastrectomy for gastric cancer. Surg Endosc. 2014 Oct;28(10):2795-802. doi: 10.1007/s00464-014-3547-1. Epub 2014 May 2.

    PMID: 24789136BACKGROUND

  • 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: 24156033BACKGROUND

  • Liao G, Chen J, Ren C, Li R, Du S, Xie G, Deng H, Yang K, Yuan Y. Robotic versus open gastrectomy for gastric cancer: a meta-analysis. PLoS One. 2013 Dec 3;8(12):e81946. doi: 10.1371/journal.pone.0081946. eCollection 2013.

    PMID: 24312610BACKGROUND

  • Hyun MH, Lee CH, Kim HJ, Tong Y, Park SS. Systematic review and meta-analysis of robotic surgery compared with conventional laparoscopic and open resections for gastric carcinoma. Br J Surg. 2013 Nov;100(12):1566-78. doi: 10.1002/bjs.9242.

    PMID: 24264778BACKGROUND

  • 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: 26482769DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Robotic Surgical ProceduresLaparoscopyConversion to Open Surgery

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Surgery, Computer-AssistedSurgical Procedures, OperativeRoboticsAutomationTechnologyTechnology, Industry, and AgricultureEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical Procedures

Study Officials

  • Amilcare Parisi, MD

    Azienda Ospedaliera S. Maria di Terni

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacopo Desiderio, MD

CONTACT

+393497531121djdesi85@hotmail.it

Amilcare Parisi, MD

CONTACT

amilcareparisi@virgilio.it

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

December 16, 2014

First Posted

December 25, 2014

Study Start

May 1, 2015

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

April 22, 2019

Record last verified: 2019-04

Locations

IT(1)