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A prospective randomised study on outcomes of a single-session combined balloon and capsule enteroscopies against capsule endoscopy alone in the management of obscure overt gastrointestinal bleeding

A prospective randomised study on outcomes of a single-session combined balloon and capsule enteroscopies against capsule endoscopy alone in the management of obscure overt gastrointestinal bleeding

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000968370
Enrollment
40
Registered
2017-07-05
Start date
2009-12-17
Completion date
2012-01-10
Last updated
2017-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to determine the best approach to investigate and treat the source of bleeding from your small intestine, which may have attributed to your low blood count (ie. anemia). Currently, the source of bleeding in the small intestine can be visualized by two endoscopic techniques. The first is called capsule endoscopy (CE), where the camera is miniaturized into a small capsule with a dimension of 20x8mm. Once swallowed, the CE is able to take pictures of gastrointestinal lining as it is spontaneously moves though the gastrointestinal tract. Whilst the pictures taken from the CE can reveal the potential causes of the gastrointestinal bleeding, it is not able to provide a tissue diagnosis or interventions to stop the bleeding. Furthermore, the locations of the potential bleeding spots are poorly located by estimation of the time taken from ingestion to the time at which the CE reaches the bleeding point. Push-pull enteroscopy is the second established technique used to visualize the small intestine by using a very long endoscope pushing its way along the intestinal tract. To improve the depth of insertion, various types of overtube with balloon(s) attached at the end of the tube are used. We used a single balloon overtube-enteroscope system at our centre. In addition to identify the bleeding focus, the major advantages of push-pull enteroscopy are the ability to obtain biopsy for diagnosis and provide endoscopic treatment to stop the bleeding. The disadvantage of this technique, however, is the inability to visualize the whole small intestine. At best, push-pull enteroscopy can only visualize half of the small intestinal tract.

Interventions

Outcomes of a single-session combined balloon and capsule enteroscopies against capsule endoscopy alone in the management of gastrointestinal bleeding After enrolment, the subjects will be randomised to either (i) Capsule endoscopy (CE) alone [conventional approach] or (ii) combined sequential single balloon enteroscopy (SBE) and CE [combined approach]. For CE alone approach, the patient will undergoes standard CE examination (approximately one hour) with the consultant gastroenterologist aft

Outcomes of a single-session combined balloon and capsule enteroscopies against capsule endoscopy alone in the management of gastrointestinal bleeding After enrolment, the subjects will be randomised to either (i) Capsule endoscopy (CE) alone [conventional approach] or (ii) combined sequential single balloon enteroscopy (SBE) and CE [combined approach]. For CE alone approach, the patient will undergoes standard CE examination (approximately one hour) with the consultant gastroenterologist after bowel preparation and fasting. The data will be downloaded after 8 hours. The need for push-pull enteroscopy will be determined by the findings of the CE. For the “combined sequential SBE_CE” approach, you will be asked to fast from the midnight before the examination and avoid any medication that can cause excessive bleeding, such as aspirin or warfarin. With the assistance of an anaesthetist, deep conscious sedation with proprofol will be administered so that the push-pull enteroscope can be performed by the gastroenterologist. The enteroscopy and the overtube will be inserted into the small intestine as far as possible. At the deepest point of insertion into the small intestine, the enteroscope will be removed with the overtube left in placed. The capsule enteroscope will then be inserted through the overtube into the small intestine. The push-pull enteroscope will be then re-inserted through the overtube so that the small intestinal mucosa can be throughout examined for any abnormalities as the scope slowly withdraw (approximately one hour). The purpose of this study is to determine the best approach to investigate and treat the source of bleeding from your small intestine, which may have attributed to your low blood count (ie. anemia). Currently, the source of bleeding in the small intestine can be visualized by two endoscopic techniques. The first is called capsule endoscopy (CE), where the camera is miniaturized into a small capsule with a dimension of 20x8mm. Once swallowed, the CE is able to take pictures of gastrointestinal lining as it is spontaneously moves though the gastrointestinal tract. Whilst the pictures taken from the CE can reveal the potential causes of the gastrointestinal bleeding, it is not able to provide a tissue diagnosis or interventions to stop the bleeding. Furthermore, the locations of the potential bleeding spots are poorly located by estimation of the time taken from ingestion to the time at which the CE reaches the bleeding point. Push-pull enteroscopy is the second established technique used to visualize the small intestine by using a very long endoscope pushing its way along the intestinal tract. To improve the depth of insertion, various types of overtube with balloon(s) attached at the end of the tube are used. We used a single balloon overtube-enteroscope system at our centre. In addition to identify the bleeding focus, the major advantages of push-pull enteroscopy are the ability to obtain biopsy for diagnosis and provide endoscopic treatment to stop the bleeding. The disadvantage of this technique, however, is the inability to visualize the whole small intestine. At best, push-pull enteroscopy can only visualize half of the small intestinal tract. The procedure is performed under deep sedation using proprofol, the dose is determined by weight of patient and propofol is administered until the procedure is completed. Data from the CE will be collected and downloaded after 8 hours.

Sponsors

Royal Adelaide Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Primary purpose
Diagnosis

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

1) Male or female subjects aged between 18 - 90 years 2) Presenting with obscure GI bleeding and related chronic anaemia, with previously normal upper and lower endoscopic investigations.

Exclusion criteria

Patients who are suspected to be at risk of capsule retention, including those who have evidence of: i) Intestinal stricture on barium study ii) Previous abdominal surgery iii) Active symptoms of subacute small bowel obstruction

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026