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Overt Obscure Gastrointestinal BleedingPhase 4NCT01654770

A Prospective Study Comparing Urgent Video Capsule Endoscopy With Urgent Double-balloon Enteroscopy

A Phase 4 study testing video capsule endoscopy and double balloon enteroscopy in people with Overt Obscure Gastrointestinal Bleeding, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Overt obscure gastrointestinal bleeding (OGIB) is a distinct clinical entity with significantly worse outcomes compared with colonic bleeding and upper GI bleeding. The mortality rate for patients with acute small bowel bleeding was 10%.1 Recently, a meta-analysis of 10 studies showed that VCE and DBE have an… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Overt Obscure Gastrointestinal Bleeding
What is being tested?
video capsule endoscopy and double balloon enteroscopy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteThailand
Study dates
Oct 2010to Mar 2012
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The consecutive patients with massive overt OGIB defined as a visible gastrointestinal bleeding (GIB) (eg, melena or hemotochezia) of unknown origin that persists after an initial negative esophagogastroduodenoscopy (EGD) and colonoscopy were recruited. Massive was defined as the need for at least 3 units of blood transfusion. All patients underwent an EGD and colonoscopy within the first 48 hrs of hospitalization.

Who cannot join

  • Exclusion Criteria pregnancy, patients with a suspected intestinal obstruction or stricture, cardiac pacemaker implantation or other electromedical device implantation, diabetic gastroparesis, a history of gastrectomy and small bowel surgery.

Trial locations and contacts

1 site in 1 country.

Thailand1 site
  • Gastroenterology Unit, King Chulalongkorn Memorial Hospital

    Patumwan, Bangkok, 10330

Other trials in Thailand

About this study

Official title: A Prospective Study Comparing Urgent Video Capsule Endoscopy With Urgent Double-balloon Enteroscopy in Patients With Massive Overt Obscure Gastrointestinal Bleeding

Overt obscure gastrointestinal bleeding (OGIB) is a distinct clinical entity with significantly worse outcomes compared with colonic bleeding and upper GI bleeding. The mortality rate for patients with acute small bowel bleeding was 10%.1 Recently, a meta-analysis of 10 studies showed that VCE and DBE have an equivalent diagnosis yields in patients with obscure GIB (62% for VCE and 56% for DBE).2 The limitation of this meta-analysis study was that the included studies examined patients with occult OGIB and overt OGIB. Comparing with occult OGIB, patients with overt OGIB are more likely to present a significant lesion that causes a recurrent bleeding which subsequently increases risk of morbidity and mortality.3 According to emergency endoscopy concept from upper and lower GIB, patients with overt OGIB have been demonstrated the usefulness of urgent VCE and urgent DBE in a diagnosis tool with an impact on clinical management.4-7 Although previous studies showed promising data about the use of urgent enteroscopy, the debate about using VCE or DBE first in patients with massive overt OGIB is still uncertain. Thus in this study, we conducted the prospective study to compare urgent VCE with urgent DBE in patients with massive overt OGIB.

Read the detailed description

Overt obscure gastrointestinal bleeding (OGIB) is a distinct clinical entity with significantly worse outcomes compared with colonic bleeding and upper GI bleeding. The mortality rate for patients with acute small bowel bleeding was 10%.1 Recently, a meta-analysis of 10 studies showed that VCE and DBE have an equivalent diagnosis yields in patients with obscure GIB (62% for VCE and 56% for DBE).2 The limitation of this meta-analysis study was that the included studies examined patients with occult OGIB and overt OGIB. Comparing with occult OGIB, patients with overt OGIB are more likely to present a significant lesion that causes a recurrent bleeding which subsequently increases risk of morbidity and mortality.3 According to emergency endoscopy concept from upper and lower GIB, patients with overt OGIB have been demonstrated the usefulness of urgent VCE and urgent DBE in a diagnosis tool with an impact on clinical management.4-7 Although previous studies showed promising data about the use of urgent enteroscopy, the debate about using VCE or DBE first in patients with massive overt OGIB is still uncertain. Thus in this study, we conducted the prospective study to compare urgent VCE with urgent DBE in patients with massive overt OGIB.

Objective The objective of this study was to compare the diagnostic yield between urgent VCE and urgent DBE in patients with massive overt OGIB.

Patients and Methods Patients Between October 2010 and March 2012, patients referred to a tertiary, King Memorial Chulalongkorn University Hospital to evaluate GIB. The consecutive patients with massive overt OGIB defined as a visible gastrointestinal bleeding (GIB) (eg, melena or hemotochezia) of unknown origin that persists after an initial negative esophagogastroduodenoscopy (EGD) and colonoscopy were recruited. Massive was defined as the need for at least 3 units of blood transfusion. All patients underwent an EGD and colonoscopy within the first 48 hrs of hospitalization. In case that the causes of gastrointestinal bleeding had not been identified, informed consent was obtained from all enrolled patients.

Exclusion criteria were pregnancy, patients with a suspected intestinal obstruction or stricture, cardiac pacemaker implantation or other electromedical device implantation, diabetic gastroparesis, a history of gastrectomy and small bowel surgery.

This study was a prospective study comparing between urgent VCE and urgent DBE. VCE and DBE were performed within the first 72 hrs of hospitalization. VCE was carried out 12 hrs before DBE. The independent operators performed VCE and DBE. The VCE results were blinded to the DBE endoscopists. A positive finding was considered that finding could explain the cause of bleeding and/or resulted in a correct therapeutic management including taking biopsy sampling. A negative finding was considered when the cause of bleeding was not detected and there was no recurrence of bleeding during the follow up period. The results of CE and DBE were evaluated whether or not the total small bowel was visualization. The diagnosis yield and the impact on clinical outcome were assessed.

CE procedure CE was performed at the bedside according to the manufacturer's instruction (MiroCam, Intromedic Co., Seoul, Republic of Korea). The technical description of CE has been documented.8 The capsule has a complementary metal oxide semiconductor sensor with an image acquisition rate of 3 frames per second. As a result of a power saving measure, the recorder incorporates two external electrodes and a single skin electrode for electric data conduction across the body which avoids the need for radiofrequency transmission.8 Patients ingested 2L of polyethylene glycol (PEG) for small bowel preparation. Patients were allowed to drink clear liquid at 2 hrs after swallowing the capsule. No any medication (prokinetic drugs, simethicone) was given during the examination. The small bowel transit time was defined as the time between the passage of the capsule through the pylorus and the arrival of the capsule in the cecum. The boundary between the jejunum and ileum was defined as the half-time of small bowel transit. 9 The positive finding on VCE were defined as either the visualization of a lesion including angioectasia, mass and ulcer or the presence of blood and/or blood clots in the small bowel lumen. The terms of negative findings were defined as no abnormalities or non-specific findings such as red spots, erosion and visible submucosal vein.

DBE procedure The standard DBE system (Fujinon Inc, Saitama, Japan) was used in the examination. The system consists of the high resolution endoscope (Fujinon EN-450T5/20) with a 200-cm working length, 8.5 mm of outer diameter and a 145-cm flexible overtube with 12 mm of outer diameter. The endoscope's working channel has a 2.2 mm in diameter. Two latex balloons were attached at the tips of both the enteroscope and the overtube and were inflated and deflated with the air from a pressure controlled system. The technique has been described in the detail previously by Yamamoto et al.10 The initial oral approach was usually selected. Whilst, the anal approach was performed initially in patients suspected ileum lesion who presented with hematochezia. The anal approach was performed in the same session when the initial route was negative. In case that the other approach was considered, the small bowel mucosa was marked by submucosal India ink injection using injection catheter at the most distal part during the oral approach and the most proximal part during the anal approach. DBE was performed under conscious sedation with midazolam and/or meperidine administration and cardiorespiratory monitoring by the experience endoscopists.

If the bleeding cause was detected, the endoscopic treatment was used to achieve hemostasis including argon plasma coagulation (APC), injection or clipping. Biopsy was taken whenever possible. In case that tumor was found, India ink was marked into submucosa around it.

Being tested
video capsule endoscopy, double balloon enteroscopy
Keywords
VCE, DBE,OGIB, consecutive, patients

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • video capsule endoscopyDevice

  • double balloon enteroscopyDevice

Study groups in NCT01654770
Study groupRoleWhat they receive
video capsule endoscopyActive comparatorVideo capsule endoscopy is performed every recruited patient.
Receives: Device: video capsule endoscopy
double balloon enteroscopyActive comparatorDouble balloon enteroscopy is performed after video capsule endoscopy in every recruited patient. (Tandem study)
Receives: Device: double balloon enteroscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. detection rate of bleeding cause

    Measured: 1 day

Secondary outcomes (1)
  1. rebleeding rate

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2012 (estimated)
  2. Study startOct 2010
  3. Primary completionMar 2011
  4. Study completionMar 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01654770
Sponsor's protocol ID
SA-001
Status last verified
Jul 2012
First submitted
30 Jul 2012
Last updated
1 Aug 2012
Results posted
No
Data monitoring committee
No

Publications

  • Aniwan S, Viriyautsahakul V, Angsuwatcharakon P, Kongkam P, Treeprasertsuk S, Rerknimitr R, Kullavanijaya P. Comparison of urgent video capsule endoscopy and urgent double-balloon endoscopy in massive obscure gastrointestinal bleeding. Hepatogastroenterology. 2014 Oct;61(135):1990-4.

    PubMed 25713900

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing video capsule endoscopy and double balloon enteroscopy in people with Overt Obscure Gastrointestinal Bleeding, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

detection rate of bleeding cause (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01654770, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2012.

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