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

Jinling Hospital, China

Status: Unknown

Conditions: CRE-induced SBO

Treatments: Drug: Gastrografin

Study type: Interventional

Funder types: Other

Identifiers

NCT03642288

Gastrografin-CRE

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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112 participants in 2 patient groups

CRE-induced SBO

Experimental group

Description:

Patients with CRE-induced SBO received GG challenge.

Treatment:

Drug: Gastrografin

ASBO

Active Comparator group

Description:

Patients with adhesive SBO (ASBO) received GG challenge.

Treatment:

Drug: Gastrografin