Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000968370
Ethics application status
Approved
Date submitted
3/05/2017
Date registered
5/07/2017
Date last updated
5/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 291836 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obscure overt gastrointestinal bleeding 303082 0
Condition category
Condition code
Oral and Gastrointestinal 302540 302540 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 302577 302577 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 297950 0
Diagnosis / Prognosis
Intervention code [2] 298342 0
Treatment: Devices
Comparator / control treatment
CE conventional approach
Control group
Active

Outcomes
Primary outcome [1] 301959 0
The primary outcomes were (i) the abnormalities detected by SBE and CE
Timepoint [1] 301959 0
During the procedure the abnormalities will be detected.
Primary outcome [2] 301960 0
and (ii) the management impact of combined SBE followed by CE approach.

Timepoint [2] 301960 0
7 days following procedure the management impact can be assessed by accessing medical records.
Clinical outcome indicators: (i) unit of blood transfusion required after the procedure (ii) the number of investigation needed after the procedure (iii) recurrence of GI bleeding
Secondary outcome [1] 334408 0
Secondary outcomes: (i) safety profile
Timepoint [1] 334408 0
The safety profile is assessed via a phone call to the patient and review of medical records within 24 hours following the procedure.
Secondary outcome [2] 334409 0
(ii) Need for repeating investigation
Timepoint [2] 334409 0
The need for repeating investigation is assessed by a review of medical records within 6 months following the procedure.
Secondary outcome [3] 334410 0
(iii) Impact on the need for the amount of blood transfusion after the enterscopies.
Timepoint [3] 334410 0
Assessment of the impact on the need and amount of blood transfusion after the enteroscopies is assessed by a review of medical records within 6 months following the procedure.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
17/12/2009
Date of last participant enrolment
Anticipated
Actual
10/01/2012
Date of last data collection
Anticipated
Actual
1/01/2013
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 296333 0
Hospital
Name [1] 296333 0
Royal Adelaide Hospital
Country [1] 296333 0
New Zealand
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Royal Adelaide Hospital, North Terrace, Adelaide, 5000, South Australia, Australia
Country
Australia
Secondary sponsor category [1] 295262 0
None
Name [1] 295262 0
Address [1] 295262 0
Country [1] 295262 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297563 0
CALHN Research Ethics Committee
Ethics committee address [1] 297563 0
Ethics committee country [1] 297563 0
Date submitted for ethics approval [1] 297563 0
Approval date [1] 297563 0
16/12/2009
Ethics approval number [1] 297563 0

Summary
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.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 74454 0
A/Prof Nam Nguyen
Address 74454 0
Level 7, North Wing, Department of Gastroenterology, Royal Adelaide Hospital, Adelaide, SA, 5000, Australia
Country 74454 0
Australia
Phone 74454 0
+61 8 8222 5214
Fax 74454 0
Email 74454 0
quocnam.nguyen@sa.gov.au
Contact person for public queries
Name 74455 0
A/Prof Nam Nguyen
Address 74455 0
Level 7, North Wing, Department of Gastroenterology, Royal Adelaide Hospital, Adelaide, SA, 5000, Australia
Country 74455 0
Australia
Phone 74455 0
+61 8 8222 5214
Fax 74455 0
Email 74455 0
quocnam.nguyen@sa.gov.au
Contact person for scientific queries
Name 74456 0
A/Prof Nam Nguyen
Address 74456 0
Level 7, North Wing, Department of Gastroenterology, Royal Adelaide Hospital, Adelaide, SA, 5000, Australia
Country 74456 0
Australia
Phone 74456 0
+61 8 8222 5214
Fax 74456 0
Email 74456 0
quocnam.nguyen@sa.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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