search
Back to results

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

Primary Purpose

CRE-induced SBO

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gastrografin
Sponsored by
Jinling Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CRE-induced SBO

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    CRE-induced SBO

    ASBO

    Arm Description

    Patients with CRE-induced SBO received GG challenge.

    Patients with adhesive SBO (ASBO) received GG challenge.

    Outcomes

    Primary Outcome Measures

    The rate of successful conservative treatment
    The rate of patients who need for operative intervention within 48 hours of randomization.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    August 20, 2018
    Last Updated
    August 21, 2018
    Sponsor
    Jinling Hospital, China
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03642288
    Brief Title
    The Use of Gastrografin in Chronic Radiation Enteropathy With Small Bowel Obstruction
    Official Title
    The Use of Gastrografin in Chronic Radiation Enteropathy With Small Bowel Obstruction：A Retrospective Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2014 (Actual)
    Primary Completion Date
    June 30, 2018 (Actual)
    Study Completion Date
    December 31, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Jinling Hospital, China

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    CRE-induced SBO

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Non-Randomized
    Enrollment
    112 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CRE-induced SBO
    Arm Type
    Experimental
    Arm Description
    Patients with CRE-induced SBO received GG challenge.
    Arm Title
    ASBO
    Arm Type
    Active Comparator
    Arm Description
    Patients with adhesive SBO (ASBO) received GG challenge.
    Intervention Type
    Drug
    Intervention Name(s)
    Gastrografin
    Intervention Description
    Patients with CRE-induced SBO or ASBO both received GG challenge.
    Primary Outcome Measure Information:
    Title
    The rate of successful conservative treatment
    Description
    The rate of patients who need for operative intervention within 48 hours of randomization.
    Time Frame
    5 days
    Secondary Outcome Measure Information:
    Title
    The time to resolution
    Description
    The time to resolution of ASIO (flatus and bowel motion).
    Time Frame
    2 weeks
    Title
    The length of hospital stays
    Description
    The length of hospital stays (in hours, calculated from the hospital admission to resolution of intestinal obstruction).
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs