NCT00153686

Brief Summary

To compare the diagnostic yield of mesenteric angiogram with CE in patients with active obscure GIB.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

May 13, 2008

Status Verified

May 1, 2008

Enrollment Period

2.4 years

First QC Date

September 8, 2005

Last Update Submit

May 9, 2008

Conditions

Gastrointestinal Hemorrhage

Keywords

Capsule EndoscopyMesenteric angiogram

Outcome Measures

Primary Outcomes (1)

  • Diagnostic yield of CE and mesenteric angiogram as the primary investigation after negative EGD and colonoscopy.

    12 months

Secondary Outcomes (1)

  • Percentage of patients with definitive diagnoses achieved;Length of stay (days) ;Transfusion requirements;No. of additional investigations (endoscopies, radiological investigation, CE etc);No. of patients requiring surgery ;12-month rebleeding rate

    12 months

Study Arms (2)

Capsule Endoscopy

EXPERIMENTAL

Capsule Endoscopy examination of small intestine

Procedure: capsule endoscopy

Mesenteric Angiogram

OTHER

Mesenteric Angiogram of the small intestine

Procedure: Mesenteric Angiogram

Interventions

capsule endoscopyPROCEDURE

capsule endoscopy of small intestine

Capsule Endoscopy
Mesenteric AngiogramPROCEDURE

Mesenteric Angiogram

Mesenteric Angiogram

Eligibility Criteria

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

You may qualify if:

  • All patients admitted to PWH medical or surgical wards with melena or hematochezia in whom OGD and colonoscopy fail to identify site of bleeding.
  • Normal or non-diagnostic OGD and colonoscopy
  • Informed consent
  • Patients presented with shock will be resuscitated for urgent endoscopy

You may not qualify if:

  • Patients remained in shock despite resuscitation.
  • Moribund patients
  • Terminal malignancy
  • Presence of pacemaker or ICD
  • Suspected or confirmed intestinal obstruction
  • Swallowing difficulties
  • Renal failure that preclude angiographic examination
  • Pregnancy
  • Age \<18
  • Refused consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endoscopy Center, Prince of Wales Hospital

Hong Kong(SAR), China

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Wai K Leung, MD

    CUHK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

June 1, 2005

Primary Completion

November 1, 2007

Study Completion

March 1, 2008

Last Updated

May 13, 2008

Record last verified: 2008-05

Locations

CN(1)