Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01654770 |
| Other study ID # |
SA-001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
July 30, 2012 |
| Last updated |
July 31, 2012 |
| Start date |
October 2010 |
| Est. completion date |
March 2012 |
Study information
| Verified date |
July 2012 |
| Source |
King Chulalongkorn Memorial Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Thailand: Ethical Committee |
| Study type |
Interventional
|
Clinical 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 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.
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.
