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.
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
- Type of treatment
- Pill or oral medicine, Medical device
- 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
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.
- Conditions
- Overt Obscure Gastrointestinal Bleeding
- 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 group | Role | What they receive |
|---|---|---|
| video capsule endoscopy | Active comparator | Video capsule endoscopy is performed every recruited patient. Receives: Device: video capsule endoscopy |
| double balloon enteroscopy | Active comparator | Double 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.
detection rate of bleeding cause
Measured: 1 day
Secondary outcomes (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.
- First posted1 Aug 2012 (estimated)
- Study startOct 2010
- Primary completionMar 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overt Obscure Gastrointestinal BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- King Chulalongkorn Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satimai Aniwan, M.D., King Chulalongkorn Memorial Hospital
- Investigators
- Vichai Viriyatsahakul, MD, MSc, Principal investigator, Gastroenterology unit, King Chulalongkorn Memorial Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Comparing Urgent Video Capsule Endoscopy With Urgent Double-balloon Enteroscopy in Patients With Massive Overt Obscure Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT01654770
- Acronym / sponsor ID
- SA-001
- Conditions
- Overt Obscure Gastrointestinal Bleeding
- Keywords
- VCE, DBE,OGIB, consecutive, patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- King Chulalongkorn Memorial HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 1 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| video capsule endoscopy | Active comparator | Device: video capsule endoscopyVideo capsule endoscopy is performed every recruited patient. |
| double balloon enteroscopy | Active comparator | Device: double balloon enteroscopyDouble balloon enteroscopy is performed after video capsule endoscopy in every recruited patient. (Tandem study) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| video capsule endoscopy | Device | video capsule endoscopy |
| double balloon enteroscopy | Device | double balloon enteroscopy |
Primary outcome
detection rate of bleeding cause
Time frame: 1 day
1 secondary outcome
rebleeding rate
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
- Derived from this study: PubMed 25713900Aniwan 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vichai Viriyatsahakul, MD, MSc principal investigator
Gastroenterology unit, King Chulalongkorn Memorial Hospital
1 site in 1 country: see every site and its status.
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.