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Application of Somatostatin for Advanced Gastric Cancer After D2 Lymph Node Dissection

Primary Purpose

Gastric Cancer After D2 Lymph Node Dissection

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Somatostatin
Sponsored by
First Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer After D2 Lymph Node Dissection

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. More than eighteen years old
  2. Gastric cancer diagnosed by pathological examination
  3. Be given informed consent
  4. Without diabetes/hyperthyroidism/Damages of functions of heart, liver and kidney/Systemic Infection/immunodeficiency

Exclusion Criteria:

  1. Contraindication of vascular puncture operation
  2. Patients who refused to take part in the programe
  3. Poor compliance of treatment
  4. Malnutrition,BMI<18
  5. with pancreatectomy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Somatostatin group

    Blank group

    Arm Description

    Patients with Advanced Gastric Cancer After D2 Lymph Node Dissection accept the Somatostatin medical therapy.

    Use the normal saline instead of somatostatin.

    Outcomes

    Primary Outcome Measures

    fistula of pancreas
    number of patients

    Secondary Outcome Measures

    amount of bleeding
    amount of bleeding after the operation
    seroperitoneum
    seroperitoneum volum of patients
    infection of incisional wound
    number of patients

    Full Information

    First Posted
    July 30, 2013
    Last Updated
    July 31, 2013
    Sponsor
    First Affiliated Hospital, Sun Yat-Sen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01914692
    Brief Title
    Application of Somatostatin for Advanced Gastric Cancer After D2 Lymph Node Dissection
    Official Title
    Application of Somatostatin for Advanced Gastric Cancer After D2 Lymph Node Dissection -a Prospective Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    July 2013 (Actual)
    Study Completion Date
    July 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    First Affiliated Hospital, Sun Yat-Sen University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Gastric cancer radical surgery related complications are common.Somatostatin is a conventional medical therapy for bleeding.This study explore the effect of Somatostatin for Advanced Gastric Cancer After D2 Lymph Node dissection.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastric Cancer After D2 Lymph Node Dissection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    2 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Somatostatin group
    Arm Type
    Experimental
    Arm Description
    Patients with Advanced Gastric Cancer After D2 Lymph Node Dissection accept the Somatostatin medical therapy.
    Arm Title
    Blank group
    Arm Type
    Placebo Comparator
    Arm Description
    Use the normal saline instead of somatostatin.
    Intervention Type
    Drug
    Intervention Name(s)
    Somatostatin
    Intervention Description
    Somatostatin is a kind of traditional medicines ,which is for the treatment of intestinal fistula，upper gastrointestinal hemorrhage.
    Primary Outcome Measure Information:
    Title
    fistula of pancreas
    Description
    number of patients
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    amount of bleeding
    Description
    amount of bleeding after the operation
    Time Frame
    six months
    Title
    seroperitoneum
    Description
    seroperitoneum volum of patients
    Time Frame
    six months
    Title
    infection of incisional wound
    Description
    number of patients
    Time Frame
    one year
    Other Pre-specified Outcome Measures:
    Title
    postoperative pancreatitis
    Description
    number of patients
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: More than eighteen years old Gastric cancer diagnosed by pathological examination Be given informed consent Without diabetes/hyperthyroidism/Damages of functions of heart, liver and kidney/Systemic Infection/immunodeficiency Exclusion Criteria: Contraindication of vascular puncture operation Patients who refused to take part in the programe Poor compliance of treatment Malnutrition,BMI<18 with pancreatectomy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Song Wu, Doctor
    Organizational Affiliation
    First Affiliated Hospital of Sun Yat-sen University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Application of Somatostatin for Advanced Gastric Cancer After D2 Lymph Node Dissection

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