Angiography Combination Laparoscopy in Patients With Obscure Gastrointestinal Bleeding

NCT02069262 | Completed DMC

• 2 other identifiers: ABT-2004-208ABT2004208
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

There were many approaches for patients with obscure gastrointestinal bleeding (OGIB). Capsule endoscopy (CE), double-balloon endoscopy, deep small-bowel spiral enteroscopy, laparoscopy, computed tomography and angiography have been recommended as investigation. However, of these techniques, the evaluation and management of patients with OGIB remains a formidable challenge. We compared the diagnostic yield and long-term outcomes of patients with OGIB randomized to angiogram combination laparoscopy or angiogram alone.

Conditions

Surgical Wound

Keywords

obscure gastrointestinal bleeding; laparoscopy; angiography

Outcome Measures

Primary Outcomes (1)

• diagnostic yield of angiography combination laparoscopy and mesenteric angiography alone in identifying the source of bleeding

  The primary outcome of this study was the diagnostic yield of angiography combination laparoscopy and mesenteric angiography alone in identifying the source of bleeding.

  5 years after initial examination

Secondary Outcomes (1)

• rebleeding rates

  follow-up to 5 years

Study Arms (2)

angiography combination laparoscopy

EXPERIMENTAL

All patients were randomized to receive either mesenteric angiography alone or angiography combination laparoscopy in a 1:1 ratio. Randomization was performed computer-generated list using a randomly permuted block design. To ensure concealed randomization, the randomization code was put in opaque envelope and kept by researchers not performing angiography or angiography combination laparoscopy. Both patients and investigators were unaware of the randomization sequence. Those who developed rebleeding during the observation would be crossed over to the other investigation modality. Patients with negative findings on the initial assigned investigation but who developed rebleeding would undergo further investigation to localize the site of bleeding.

Other: rebleeding

angiography alone

PLACEBO COMPARATOR

All patients were randomized to receive either mesenteric angiography alone or angiography combination laparoscopy in a 1:1 ratio. Randomization was performed computer-generated list using a randomly permuted block design. To ensure concealed randomization, the randomization code was put in opaque envelope and kept by researchers not performing angiography or angiography combination laparoscopy. Both patients and investigators were unaware of the randomization sequence.

Other: rebleeding

Interventions

rebleeding OTHER

Those who developed rebleeding during the observation would be crossed over to the other investigation modality.

Also known as: angiography, laparoscopy

angiography alone; angiography combination laparoscopy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- melena or hematochezia receive at least 2 times upper gastrointestinal endoscopy nondiagnostic upper GI endoscopy were also offered at least 2 times colonoscopy endoscopies were performed by experienced endoscopists.

You may not qualify if:

• \- \< 18 years, pregnant moribund conditions terminal malignancy contrast allergy impaired renal function (serum creatinine \> 150 µmol/l)

Sponsors & Collaborators

• The Second People's Hospital of GuangDong Province: lead

Study Sites (1)

The Second People's Hospital of GuangDong Province

Guangzhou, Guangdong, 510317, China

Location

MeSH Terms

Conditions

Surgical Wound

Interventions

Cerebral Angiography; Laparoscopy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Angiography; Radiography; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques, Neurological; Investigative Techniques; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• kaiyun chen, phD

  The Second People's Hospital of GuangDong Province

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 15, 2014
• First Posted: February 24, 2014
• Study Start: January 1, 2003
• Primary Completion: November 1, 2008
• Study Completion: January 1, 2014
• Last Updated: February 24, 2014

Record last verified: 2003-01

Locations

CN (1)