Angiography Combination Laparoscopy in Patients With Obscure Gastrointestinal Bleeding

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.

Study Overview

• Status: Completed
• Conditions: Surgical Wound
• Intervention / Treatment: Other: rebleeding

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • GuangZhou, Guangdong, China, 510317
      • The Second People's Hospital of Guangdong Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: rebleeding; Those who developed rebleeding during the observation would be crossed over to the other investigation modality.; Other Names: angiography; laparoscopy
Placebo Comparator: 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.	Other: rebleeding; Those who developed rebleeding during the observation would be crossed over to the other investigation modality.; Other Names: angiography; laparoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
rebleeding rates	Secondary outcome measures included long-term rebleeding rates, further hospital admissions for bleeding or anemia, further blood transfusion, and death.	follow-up to 5 years

Collaborators and Investigators

• Sponsor: The Second People's Hospital of GuangDong Province
• Investigators: Study Chair: kaiyun chen, phD, The Second People's Hospital of Guangdong Province

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: February 15, 2014
• First Submitted That Met QC Criteria: February 19, 2014
• First Posted (Estimate): February 24, 2014

Study Record Updates

• Last Update Posted (Estimate): February 24, 2014
• Last Update Submitted That Met QC Criteria: February 19, 2014
• Last Verified: January 1, 2003

More Information

Terms related to this study

• Keywords: laparoscopy; angiography; obscure gastrointestinal bleeding
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Wounds and Injuries; Gastrointestinal Diseases; Hemorrhage; Surgical Wound; Gastrointestinal Hemorrhage
• Other Study ID Numbers: ABT-2004-208; ABT2004208 (Registry Identifier: ABT-2004-208)