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

Not Applicable

• Conditions: CRE-induced SBO
• Interventions: Drug: Gastrografin

• Registration Number: NCT03642288
• Lead Sponsor: Jinling Hospital, China

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-01
• Primary Completion: 2018-06-30
• Status Verified: 2018-08
• Study First Submitted: 2018-08-20
• Study First Submitted QC: 2018-08-21
• Last Update Submitted: 2018-08-21
• Study First Posted: 2018-08-22
• Last Update Posted: 2018-08-22
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 112

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CRE-induced SBO	Gastrografin	Patients with CRE-induced SBO received GG challenge.
ASBO	Gastrografin	Patients with adhesive SBO (ASBO) received GG challenge.

Primary Outcome Measures

Name	Time	Method
The rate of successful conservative treatment	5 days	The rate of patients who need for operative intervention within 48 hours of randomization.

Secondary Outcome Measures

Name	Time	Method
The time to resolution	2 weeks	The time to resolution of ASIO (flatus and bowel motion).
The length of hospital stays	2 weeks	The length of hospital stays (in hours, calculated from the hospital admission to resolution of intestinal obstruction).