Gastric Cancer After D2 Lymph Node DissectionPhase 4NCT01914692
Application of Somatostatin for Advanced Gastric Cancer After D2 Lymph Node Dissection
A Phase 4 study testing Somatostatin in people with Gastric Cancer After D2 Lymph Node Dissection, run by First Affiliated Hospital, Sun Yat-Sen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer After D2 Lymph Node Dissection
- What is being tested?
- Somatostatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jul 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Contraindication of vascular puncture operation
- Patients who refused to take part in the programe
- Poor compliance of treatment
- Malnutrition,BMI<18
- with pancreatectomy
About this study
Official title: 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.
- Being tested
- Somatostatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatostatinDrug
Somatostatin is a kind of traditional medicines ,which is for the treatment of intestinal fistula，upper gastrointestinal hemorrhage.
| Study group | Role | What they receive |
|---|---|---|
| Somatostatin group | Experimental | Patients with Advanced Gastric Cancer After D2 Lymph Node Dissection accept the Somatostatin medical therapy. Receives: Drug: Somatostatin |
| Blank group | Placebo comparator | Use the normal saline instead of somatostatin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
fistula of pancreas
number of patients
Measured: one year
Secondary outcomes (3)
amount of bleeding
amount of bleeding after the operation
Measured: six months
seroperitoneum
seroperitoneum volum of patients
Measured: six months
infection of incisional wound
number of patients
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer After D2 Lymph Node DissectionStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Shaochuan, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Song Wu, Doctor, Study chair, First Affiliated Hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914692
- Sponsor's protocol ID
- nova-0426
- Status last verified
- Jul 2013
- First submitted
- 30 Jul 2013
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Somatostatin for Advanced Gastric Cancer After D2 Lymph Node Dissection -a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01914692
- Acronym / sponsor ID
- nova-0426
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 2 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Somatostatin group | Experimental | Drug: SomatostatinPatients with Advanced Gastric Cancer After D2 Lymph Node Dissection accept the Somatostatin medical therapy. |
| Blank group | Placebo comparator | –Use the normal saline instead of somatostatin. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Contraindication of vascular puncture operation
- Patients who refused to take part in the programe
- Poor compliance of treatment
- Malnutrition,BMI<18
- with pancreatectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SomatostatinSomatostatin is a kind of traditional medicines ,which is for the treatment of intestinal fistula，upper gastrointestinal hemorrhage. | Drug | Somatostatin group |
Primary outcome
fistula of pancreas
Time frame: one year
number of patients
3 secondary outcomes
amount of bleeding
Time frame: six months
seroperitoneum
Time frame: six months
infection of incisional wound
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
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RecruitingPhase 3
Laparoscopic Gastrectomy With D2 Lymphadenectomy Combined With Hyperthermic Intraperitoneal Chemotherapy (HIPEC) or Not
Gastric Cancer
RecruitingObservational study
Analysis of Lymph Node Metastasis and Tumor Deposit in the Short Gastric Mesentery Following Total Gastrectomy for Gastric Cancer
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Song Wu, Doctor study chair
First Affiliated Hospital of Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Somatostatin in people with Gastric Cancer After D2 Lymph Node Dissection, run by First Affiliated Hospital, Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fistula of pancreas (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2013.