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

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ClinicalTrials.gov Identifier: NCT02751086
Recruitment Status : Recruiting
First Posted : April 26, 2016
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):
Amilcare Parisi, International Study Group on Minimally Invasive Surgery for Gastric Cancer

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.


Condition or disease Intervention/treatment
Gastric Cancer Procedure: Robotic Gastrectomy Procedure: Laparoscopic Gastrectomy

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
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : April 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Group/Cohort Intervention/treatment
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.



Primary Outcome Measures :
  1. Rate of patients with intraoperative adverse events [ Time Frame: During surgery ]
    events other than the normal course of the 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 ]
    subjects alive at the planned endpoint

  4. Rate of patients alive [ Time Frame: 2 year after surgery ]
    subjects alive at the planned endpoint

  5. Rate of patients alive [ Time Frame: 3 year after surgery ]
    subjects alive at the planned endpoint

  6. Rate of patients alive [ Time Frame: 4 year after surgery ]
    subjects alive at the planned endpoint

  7. Rate of patients alive [ Time Frame: 5 year after surgery ]
    subjects alive at the planned endpoint


Secondary Outcome Measures :
  1. 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

  2. Rate of complications after discharge [ Time Frame: 5 year after surgery ]
    any surgical related event after patient's discharge



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects with gastric cancer eligible for curative surgery.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751086


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

Locations
Italy
Department of Digestive Surgery, St. Mary's Hospital, University of Perugia Recruiting
Terni, Italy, 05100
Contact: Amilcare Parisi       amilcareparisi@virgilio.it   
Contact: Jacopo Desiderio       djdesi85@hotmail.it   
Sponsors and Collaborators
International Study Group on Minimally Invasive Surgery for Gastric Cancer
Investigators
Principal Investigator: Amilcare Parisi, MD St. Mary's Hospital of Terni

Additional Information:
Study Data/Documents: Study Protocol, study information, news  This link exits the ClinicalTrials.gov site

The study is open to other interested Institutions.

Correspondance to:

Jacopo Desiderio, MD djdesi85@hotmail.it



Publications:

Responsible Party: Amilcare Parisi, Principal Investigator, International Study Group on Minimally Invasive Surgery for Gastric Cancer
ClinicalTrials.gov Identifier: NCT02751086     History of Changes
Other Study ID Numbers: 002
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Amilcare Parisi, International Study Group on Minimally Invasive Surgery for Gastric Cancer:
minimally invasive surgery
gastrectomy
robotic surgery
laparoscopic surgery
laparoscopy
robot-assisted
robotic
robotic gastrectomy
laparoscopic gastrectomy
minimally invasive gastrectomy

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases