The Use of Gastrografin in Chronic Radiation Enteropathy With Small Bowel Obstruction

NCT ID: NCT03642288

Last Updated: 2018-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-01

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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CRE-induced SBO

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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CRE-induced SBO

Patients with CRE-induced SBO received GG challenge.

Group Type EXPERIMENTAL

Gastrografin

Intervention Type DRUG

Patients with CRE-induced SBO or ASBO both received GG challenge.

ASBO

Patients with adhesive SBO (ASBO) received GG challenge.

Group Type ACTIVE_COMPARATOR

Gastrografin

Intervention Type DRUG

Patients with CRE-induced SBO or ASBO both received GG challenge.

Interventions

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Gastrografin

Patients with CRE-induced SBO or ASBO both received GG challenge.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jinling Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Ding Chao

Clinical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Gastrografin-CRE

Identifier Type: -

Identifier Source: org_study_id

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