NCT01914692

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2013

Completed
Last Updated

August 2, 2013

Status Verified

July 1, 2013

Enrollment Period

6 months

First QC Date

July 30, 2013

Last Update Submit

July 31, 2013

Conditions

Gastric Cancer After D2 Lymph Node Dissection

Outcome Measures

Primary Outcomes (1)

  • fistula of pancreas

    number of patients

    one year

Secondary Outcomes (3)

  • amount of bleeding

    six months

  • seroperitoneum

    six months

  • infection of incisional wound

    one year

Other Outcomes (1)

  • postoperative pancreatitis

    one year

Study Arms (2)

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

SomatostatinDRUG

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

Somatostatin group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Contraindication of vascular puncture operation
  • Patients who refused to take part in the programe
  • Poor compliance of treatment
  • Malnutrition,BMI\<18
  • with pancreatectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Somatostatin

Intervention Hierarchy (Ancestors)

Pituitary Hormone Release Inhibiting HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPancreatic HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Song Wu, Doctor

    First Affiliated Hospital of Sun Yat-sen University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate

Study Record Dates

First Submitted

July 30, 2013

First Posted

August 2, 2013

Study Start

January 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

August 2, 2013

Record last verified: 2013-07