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

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ClinicalTrials.gov Identifier: NCT01914692
Recruitment Status : Completed
First Posted : August 2, 2013
Last Update Posted : August 2, 2013
Sponsor:
Information provided by (Responsible Party):
Wang Shaochuan, First Affiliated Hospital, Sun Yat-Sen University

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

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Study Type : Interventional  (Clinical Trial)
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 : January 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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.



Primary Outcome Measures :
  1. fistula of pancreas [ Time Frame: one year ]
    number of patients


Secondary Outcome Measures :
  1. amount of bleeding [ Time Frame: six months ]
    amount of bleeding after the operation

  2. seroperitoneum [ Time Frame: six months ]
    seroperitoneum volum of patients

  3. infection of incisional wound [ Time Frame: one year ]
    number of patients


Other Outcome Measures:
  1. postoperative pancreatitis [ Time Frame: one year ]
    number of patients



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01914692


Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Investigators
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Study Chair: Song Wu, Doctor First Affiliated Hospital of Sun Yat-sen University

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Responsible Party: Wang Shaochuan, Postgraduate, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01914692     History of Changes
Other Study ID Numbers: nova-0426
First Posted: August 2, 2013    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: July 2013
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Somatostatin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs