NCT03642288

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

August 22, 2018

Status Verified

August 1, 2018

Enrollment Period

4.2 years

First QC Date

August 20, 2018

Last Update Submit

August 21, 2018

Conditions

CRE-induced SBO

Outcome Measures

Primary Outcomes (1)

  • The rate of successful conservative treatment

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

    5 days

Secondary Outcomes (2)

  • The time to resolution

    2 weeks

  • The length of hospital stays

    2 weeks

Study Arms (2)

CRE-induced SBO

EXPERIMENTAL

Patients with CRE-induced SBO received GG challenge.

Drug: Gastrografin

ASBO

ACTIVE COMPARATOR

Patients with adhesive SBO (ASBO) received GG challenge.

Drug: Gastrografin

Interventions

GastrografinDRUG

Patients with CRE-induced SBO or ASBO both received GG challenge.

ASBOCRE-induced SBO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Diatrizoate Meglumine

Intervention Hierarchy (Ancestors)

MeglumineSorbitolSugar AlcoholsAlcoholsOrganic ChemicalsDiatrizoateTriiodobenzoic AcidsIodobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsHexosaminesAmino SugarsCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Doctor

Study Record Dates

First Submitted

August 20, 2018

First Posted

August 22, 2018

Study Start

April 1, 2014

Primary Completion

June 30, 2018

Study Completion

December 31, 2018

Last Updated

August 22, 2018

Record last verified: 2018-08