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

Sponsor
Jinling Hospital, China (Other)
Overall Status
Unknown status
CT.gov ID
NCT03642288
Collaborator
(none)
112
Enrollment
2
Arms
57
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
112 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
The Use of Gastrografin in Chronic Radiation Enteropathy With Small Bowel Obstruction：A Retrospective Study
Actual Study Start Date :
Apr 1, 2014
Actual Primary Completion Date :
Jun 30, 2018
Anticipated Study Completion Date :
Dec 31, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. The time to resolution [2 weeks]

    The time to resolution of ASIO (flatus and bowel motion).

  2. The length of hospital stays [2 weeks]

    The length of hospital stays (in hours, calculated from the hospital admission to resolution of intestinal obstruction).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Jinling Hospital, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ding Chao, Clinical Doctor, Jinling Hospital, China
ClinicalTrials.gov Identifier:
NCT03642288
Other Study ID Numbers:
  • Gastrografin-CRE
First Posted:
Aug 22, 2018
Last Update Posted:
Aug 22, 2018
Last Verified:
Aug 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Intestinal Obstruction

Study Results

No Results Posted as of Aug 22, 2018