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

Sponsor

First Affiliated Hospital, Sun Yat-Sen University (Other)

Overall Status

Completed

CT.gov ID

NCT01914692

Collaborator

(none)

Enrollment

Arms

5.9

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer After D2 Lymph Node Dissection	Drug: Somatostatin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Application of Somatostatin for Advanced Gastric Cancer After D2 Lymph Node Dissection -a Prospective Randomized Controlled Study

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Somatostatin group Patients with Advanced Gastric Cancer After D2 Lymph Node Dissection accept the Somatostatin medical therapy.	Drug: Somatostatin Somatostatin is a kind of traditional medicines ,which is for the treatment of intestinal fistula，upper gastrointestinal hemorrhage.
Placebo Comparator: Blank group Use the normal saline instead of somatostatin.

Arm

Intervention/Treatment

Experimental: Somatostatin group

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

Drug: Somatostatin

Somatostatin is a kind of traditional medicines ,which is for the treatment of intestinal fistula，upper gastrointestinal hemorrhage.

Placebo Comparator: Blank group

Use the normal saline instead of somatostatin.

Outcome Measures

Primary Outcome Measures

fistula of pancreas [one year]
number of patients

Secondary Outcome Measures

amount of bleeding [six months]
amount of bleeding after the operation
seroperitoneum [six months]
seroperitoneum volum of patients
infection of incisional wound [one year]
number of patients

Other Outcome Measures

postoperative pancreatitis [one year]
number of patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

First Affiliated Hospital, Sun Yat-Sen University

Investigators

Study Chair: Song Wu, Doctor, First Affiliated Hospital of Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wang Shaochuan, Postgraduate, First Affiliated Hospital, Sun Yat-Sen University

ClinicalTrials.gov Identifier:

NCT01914692

Other Study ID Numbers:

nova-0426

First Posted:

Aug 2, 2013

Last Update Posted:

Aug 2, 2013

Last Verified:

Jul 1, 2013

Additional relevant MeSH terms:

Stomach Neoplasms

Somatostatin

Study Results

No Results Posted as of Aug 2, 2013