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

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

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.

Study Overview

• Status: Completed
• Conditions: Gastric Cancer After D2 Lymph Node Dissection
• Intervention / Treatment: Drug: Somatostatin

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
amount of bleeding	amount of bleeding after the operation	six months
seroperitoneum	seroperitoneum volum of patients	six months
infection of incisional wound	number of patients	one year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pancreatitis	number of patients	one year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ACTUAL): July 1, 2013
• Study Completion (ACTUAL): July 1, 2013

Study Registration Dates

• First Submitted: July 30, 2013
• First Submitted That Met QC Criteria: July 31, 2013
• First Posted (ESTIMATE): August 2, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): August 2, 2013
• Last Update Submitted That Met QC Criteria: July 31, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Somatostatin
• Other Study ID Numbers: nova-0426