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Robotic, Laparoscopic and Open Surgery for Gastric Cancer Compared on Surgical, Clinical and Oncological Outcomes

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ClinicalTrials.gov Identifier: NCT02325453
Recruitment Status : Recruiting
First Posted : December 25, 2014
Last Update Posted : April 22, 2019
Sponsor:
Collaborators:
Fondazione CARIT
LOGIX S.r.l.
Information provided by (Responsible Party):
Amilcare Parisi, Azienda Ospedaliera Santa Maria, Terni, Italy

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.


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

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 7000 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: A Multi-Institutional Chart Review to Compare the Outcomes of Robotic, Laparoscopic and Open Surgery for Gastric Cancer.
Study Start Date : May 2015
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Group/Cohort Intervention/treatment
Robotic Surgery
Patients underwent gastric surgery through the use of a robotic system.
Procedure: Robotic Surgery
Surgical procedure performed with a robotic system.

Laparoscopic Surgery
Patients underwent gastric surgery with laparoscopic procedures.
Procedure: Laparoscopic Surgery
Surgical procedure performed with laparoscopic techniques.

Open Surgery
Patients underwent gastric surgery with open approach.
Procedure: Open Surgery
Traditional approach for gastric cancer.




Primary Outcome Measures :
  1. Compare robotic and laparoscopic surgery with the open approach in terms of safety and feasibility. (Intraoperative complications.) [ Time Frame: Intraoperative. ]
    Intraoperative complications.

  2. 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.) [ Time Frame: Intraoperative. ]
    Number of lymph nodes retrieved.

  3. 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.) [ Time Frame: Assessment during an average period of 10 days after surgery. ]
    Days of hospitalization after surgery until discharge.

  4. Compare the incidence, types and severity of early postoperative complications after gastrectomy by the three approaches. (Score based on the Clavien-Dindo classification system.) [ Time Frame: Assessment during an average period of 10 days after surgery. ]
    Score based on the Clavien-Dindo classification system.

  5. Verify whether minimally invasive approaches ensure the same effectiveness than open surgery. (Overall survival.) [ Time Frame: Assessment at 1, 3, 5 years from surgery. ]
    Overall survival.

  6. Compare the three treatment arms in terms of tumor recurrence after treatment. (Disease-free survival) [ Time Frame: Assessment at 1, 3, 5 years from surgery. ]
    Disease-free survival.


Secondary Outcome Measures :
  1. Verify the safety of intracorporeal anastomosis in comparison with extracorporeal anastomosis. (Anastomotic leakage) [ Time Frame: Assessment during an average period of 10 days after surgery. ]
    Anastomotic leakage.

  2. Compare the intracorporeal anastomosis with the extracorporeal anastomosis to evaluate post-operative recovery. (Days of hospitalization after surgery until discharge.) [ Time Frame: Assessment during an average period of 10 days after surgery. ]
    Days of hospitalization after surgery until discharge.

  3. Verify whether robotic gastrectomy, compared with laparoscopic or open techniques, is capable of improving postoperative surgical stress. (Granulocyte-to-lymphocyte ratio.) [ Time Frame: Assessment during an average period of 10 days after surgery. ]
    Granulocyte-to-lymphocyte ratio.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects undergoing surgery for gastric cancer with robotic, laparoscopic or open approaches and subsequent follow-up.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT02325453


Contacts
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Contact: Jacopo Desiderio, MD +393497531121 djdesi85@hotmail.it
Contact: Amilcare Parisi, MD amilcareparisi@virgilio.it

Locations
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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
Fondazione CARIT
LOGIX S.r.l.
Investigators
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Principal Investigator: Amilcare Parisi, MD Azienda Ospedaliera S. Maria di Terni

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amilcare Parisi, Dr., Azienda Ospedaliera Santa Maria, Terni, Italy
ClinicalTrials.gov Identifier: NCT02325453     History of Changes
Other Study ID Numbers: 001
First Posted: December 25, 2014    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Keywords provided by Amilcare Parisi, Azienda Ospedaliera Santa Maria, Terni, Italy:
Robotic Surgery
Laparoscopic Surgery
Minimally Invasive Surgery
Robotic Gastrectomy
Laparoscopic Gastrectomy
Open Gastrectomy
Gastric Surgery
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases