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

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.

Study Overview

• Status: Unknown
• Conditions: CRE-induced SBO
• Intervention / Treatment: Drug: Gastrografin

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CRE-induced SBO; Patients with CRE-induced SBO received GG challenge.	Drug: Gastrografin; Patients with CRE-induced SBO or ASBO both received GG challenge.
ACTIVE_COMPARATOR: ASBO; Patients with adhesive SBO (ASBO) received GG challenge.	Drug: Gastrografin; Patients with CRE-induced SBO or ASBO both received GG challenge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of successful conservative treatment	The rate of patients who need for operative intervention within 48 hours of randomization.	5 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jinling Hospital, China

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2014
• Primary Completion (ACTUAL): June 30, 2018
• Study Completion (ANTICIPATED): December 31, 2018

Study Registration Dates

• First Submitted: August 20, 2018
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (ACTUAL): August 22, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 22, 2018
• Last Update Submitted That Met QC Criteria: August 21, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction
• Other Study ID Numbers: Gastrografin-CRE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No