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
About this trial
This is an interventional treatment trial for Gastric Cancer After D2 Lymph Node Dissection
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
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
NCT ID
NCT01914692
First Posted
July 30, 2013
Last Updated
July 31, 2013
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
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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