CRE-induced SBONCT03642288
The Use of Gastrografin in Chronic Radiation Enteropathy With Small Bowel Obstruction
A study testing Gastrografin in people with CRE-induced SBO, run by Jinling Hospital, China.
Trial summary
Chronic radiation enteropathy (CRE) is a major issue for long-term cancer survivors. The aim of this study was to clarify the diagnostic and therapeutic effect of the Gastrografin (GG) challenge for patients with CRE induced small bowel obstruction SBO. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CRE-induced SBO
- What is being tested?
- Gastrografin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2014to 31 Dec 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- with a first diagnosis of CRE combined with SBO and ASBO that was determined by clinical history, computed tomography (CT) manifestation, and confirmed by intraoperative and histologic findings.
- radiation therapy completed at least 6 months before enrolment.
Who cannot join
- a colostomy or ileostomy;
- large bowel obstruction;
- with a known history of either allergy or hypersensitivity to iodinated contrast agents;
- with signs of strangulation;
- metastatic disease;
- obstruction within 4 weeks after a recent operation or serious comorbidity.
About this study
Official title: The Use of Gastrografin in Chronic Radiation Enteropathy With Small Bowel Obstruction：A Retrospective Study
Chronic radiation enteropathy (CRE) is a major issue for long-term cancer survivors. The aim of this study was to clarify the diagnostic and therapeutic effect of the Gastrografin (GG) challenge for patients with CRE induced small bowel obstruction SBO.
- Conditions
- CRE-induced SBO
- Being tested
- Gastrografin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GastrografinDrug
Patients with CRE-induced SBO or ASBO both received GG challenge.
| Study group | Role | What they receive |
|---|---|---|
| CRE-induced SBO | Experimental | Patients with CRE-induced SBO received GG challenge. Receives: Drug: Gastrografin |
| ASBO | Active comparator | Patients with adhesive SBO (ASBO) received GG challenge. Receives: Drug: Gastrografin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of successful conservative treatment
The rate of patients who need for operative intervention within 48 hours of randomization.
Measured: 5 days
Secondary outcomes (2)
The time to resolution
The time to resolution of ASIO (flatus and bowel motion).
Measured: 2 weeks
The length of hospital stays
The length of hospital stays (in hours, calculated from the hospital admission to resolution of intestinal obstruction).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start1 Apr 2014
- Primary completion30 Jun 2018
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRE-induced SBOStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding Chao, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642288
- Sponsor's protocol ID
- Gastrografin-CRE
- Status last verified
- Aug 2018
- First submitted
- 20 Aug 2018
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Gastrografin in Chronic Radiation Enteropathy With Small Bowel Obstruction：A Retrospective Study
- ClinicalTrials.gov ID
- NCT03642288
- Acronym / sponsor ID
- Gastrografin-CRE
- Conditions
- CRE-induced SBO
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 22 Aug 2018 (actual)
- 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.
Chronic radiation enteropathy (CRE) is a major issue for long-term cancer survivors. The aim of this study was to clarify the diagnostic and therapeutic effect of the Gastrografin (GG) challenge for patients with CRE induced small bowel obstruction SBO.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRE-induced SBO | Experimental | Drug: GastrografinPatients with CRE-induced SBO received GG challenge. |
| ASBO | Active comparator | Drug: GastrografinPatients with adhesive SBO (ASBO) received GG challenge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- with a first diagnosis of CRE combined with SBO and ASBO that was determined by clinical history, computed tomography (CT) manifestation, and confirmed by intraoperative and histologic findings.
- radiation therapy completed at least 6 months before enrolment.
Key exclusion criteria (6 listed)
- a colostomy or ileostomy;
- large bowel obstruction;
- with a known history of either allergy or hypersensitivity to iodinated contrast agents;
- with signs of strangulation;
- metastatic disease;
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 |
|---|---|---|
| GastrografinPatients with CRE-induced SBO or ASBO both received GG challenge. | Drug | ASBO, CRE-induced SBO |
Primary outcome
The rate of successful conservative treatment
Time frame: 5 days
The rate of patients who need for operative intervention within 48 hours of randomization.
2 secondary outcomes
The time to resolution
Time frame: 2 weeks
The length of hospital stays
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Gastrografin in people with CRE-induced SBO, run by Jinling Hospital, China.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 Aug 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
The rate of successful conservative treatment (time frame: 5 days). 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 22 Aug 2018.