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

CRE-induced SBO Clinical Trial

Official title:

The Use of Gastrografin in Chronic Radiation Enteropathy With Small Bowel Obstruction：A Retrospective Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03642288
• Other study ID #: Gastrografin-CRE
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2014
• Est. completion date: December 31, 2018

Study information

• Verified date: August 2018
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 112
• Est. completion date: December 31, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• with a first diagnosis of CRE combined with SBO and ASBO that was determined by clinical history, computed tomography (CT) manifestation, and con?rmed by intraoperative and histologic ?ndings.

• 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.

Related Conditions & MeSH terms

• CRE-induced SBO
• Intestinal Diseases
• Intestinal Obstruction

Intervention

Drug:
• Gastrografin
Patients with CRE-induced SBO or ASBO both received GG challenge.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of successful conservative treatment	The rate of patients who need for operative intervention within 48 hours of randomization.	5 days
Secondary	The time to resolution	The time to resolution of ASIO (flatus and bowel motion).	2 weeks
Secondary	The length of hospital stays	The length of hospital stays (in hours, calculated from the hospital admission to resolution of intestinal obstruction).	2 weeks