Application of Somatostatin for Advanced Gastric Cancer A... | NCT01914692

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

NCT01914692

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Status

Completed

Last Update Posted

Aug 2, 2013Estimated

Enrollment

2Actual

Phase

Phase 4

Conditions

Gastric Cancer After D2 Lymph Node Dissection

Interventions

Somatostatin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jul 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Jul 30, 2013

First Submission Date that Met QC Criteria

Jul 31, 2013

First Posted Date

Aug 2, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2013

Last Update Posted Date

Aug 2, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wang Shaochuan, Postgraduate, First Affiliated Hospital, Sun Yat-Sen UniversityPrincipal Investigator

Lead Sponsor

First Affiliated Hospital, Sun Yat-Sen UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Somatostatin group	Experimental	Patients with Advanced Gastric Cancer After D2 Lymph Node Dissection accept the Somatostatin medical therapy.	Drug: Somatostatin
Blank group	Placebo Comparator	Use the normal saline instead of somatostatin.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Somatostatin	Drug	Somatostatin is a kind of traditional medicines ,which is for the treatment of intestinal fistula，upper gastrointestinal hemorrhage.	Somatostatin group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
fistula of pancreas	number of patients	one year

Secondary Outcomes

Measure	Description	Time Frame
amount of bleeding	amount of bleeding after the operation	six months
seroperitoneum	seroperitoneum volum of patients	six months

Other Outcomes

Measure	Description	Time Frame
postoperative pancreatitis	number of patients	one year

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Song Wu, Doctor	First Affiliated Hospital of Sun Yat-sen University	Study Chair

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013004	Somatostatin

Ancestor Terms

ID	Term
D010905	Pituitary Hormone Release Inhibiting Hormones
D007028	Hypothalamic Hormones
D036361	Peptide Hormones
D006728	Hormones

Browse Leaves

Not provided

Browse Branches

Not provided