Angiography Combination Laparoscopy in Patients With Obscure Gastrointestinal Bleeding

NCT ID: NCT02069262

Last Updated: 2014-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2014-01-31

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.

Detailed Description

Consecutive patients who presented with OGIB to the second people's hospital of GuangDong province between January 2003 and November 2008 were recruited. This study was approved by the ethical committee of the Second people's Hospital of GuangDong Province and was designed according to the CONSORT (Consolidated Standards of Reporting Trials) guidelines. All patients gave written informed consent before beginning the study. As a standard protocol, all patients presented with melena or hematochezia would receive at least 2 times upper gastrointestinal endoscopy before admission. Patients who had nondiagnostic upper GI endoscopy were also offered at least 2 times colonoscopy before admission. All gastrointestinal endoscopies were performed by experienced endoscopists (hanning Wang). OGIB were defined as patients who had nondiagnostic upper endoscopy and colonoscopy.

Patients who were < 18 years, pregnant, in moribund conditions, or with terminal malignancy were excluded. Patients with contrast allergy and impaired renal function (serum creatinine > 150 µmol/l) were also not eligible for this study. 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.

Conditions

Surgical Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

angiography combination laparoscopy

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.

Group Type: EXPERIMENTAL

rebleeding

Intervention Type: OTHER

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

angiography alone

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.

Group Type: PLACEBO_COMPARATOR

rebleeding

Intervention Type: OTHER

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

Interventions

rebleeding

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

Intervention Type: OTHER

Other Intervention Names

angiography; laparoscopy

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second People's Hospital of GuangDong Province

OTHER

Sponsor Role: lead

Responsible Party

KaiYun Chen

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

kaiyun chen, phD

Role: STUDY_CHAIR

The Second People's Hospital of GuangDong Province

Locations

The Second People's Hospital of GuangDong Province

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

ABT2004208

Identifier Type: REGISTRY

Identifier Source: secondary_id

ABT-2004-208

Identifier Type: -

Identifier Source: org_study_id