Single Balloon EnteroscopyNCT01942863
Effect of Water Exchange Method on Single-balloon Enteroscopy
A study testing water exchange single balloon enteroscopy, CO2 insufflation single balloon enteroscopy and Procedural Requirements in people with Single Balloon Enteroscopy, run by Air Force Military Medical University, China at 2 sites in China.
Trial summary
Enteroscopy, including double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) and spiral enteroscopy (SE) currently, have shown good performances in small bowel diagnostics and seem to be useful in the clinical routine. However, enteroscopy is a time-consuming procedure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Single Balloon Enteroscopy
- What is being tested?
- water exchange single balloon enteroscopy, CO2 insufflation single balloon enteroscopy and Procedural Requirements
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesChina
- Study dates
- Dec 2013to Aug 2015
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suspected small-bowel disease
Who cannot join
- Prior small-bowel surgery
- Total examination of small bowel not planned when image modalities showed
- lesions obviously located on duodenum, proximal jejunum or distal ileum
- High-risk esophageal varices
- Pregnancy or lactation
- Inability to tolerate sedation or general anesthesia because of comorbidities
- Inability to provide informed consent
Trial locations and contacts
2 sites in 1 country.
China2 sites
Endoscopy Center of Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710032
Xijing hospital of Digestive Diseases
Xi'an, Shaanxi, 710032
About this study
Official title: Effect of Water Exchange Method on Intubation Depth and Diagnostic Yield in Patients Undergoing Single-balloon Enteroscopy: a Prospective, Randomized, Controlled, Patient-blind Trial.
Enteroscopy, including double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) and spiral enteroscopy (SE) currently, have shown good performances in small bowel diagnostics and seem to be useful in the clinical routine. However, enteroscopy is a time-consuming procedure. During common practice, large volumes of air need to be insufflated for good visualization. It leads to significant distention of the small bowel during the examination, which makes further intubation more technically challenging because of the formation of distended bowel loops and acute angulations and limits the maximal intubation length. According to the published data, the oral insertion depth of different kinds of enteroscopy is limited to approximately 240 cm. The total examination rate range form 18% to 86% for DBE and 0% to 11% for SBE.
It is thought that the intubation depth in small bowel determines the diagnostic yield and the following treatment. The deeper the enteroscopy is advanced into the small bowel, the more lesions may be found and treated. In order to improve the intubation depth of balloon enteroscopy, several methods, such as carbon dioxide insufflation and decompression side tube-equipped device, have been tried and showed positive effects. CO2 insufflation could also reduce severe pain during DBE and residual gas retention after the procedure because of rapid absorption. However, it is not known how much CO2 insufflation can decrease the distention of small bowel and the formation of bowel loops.
Read more
Recently, the use of water infusion in lieu of air insufflation has been shown to facilitate completion of colonoscopy, even in potentially difficult patients with prior abdominal or pelvic surgery. Water exchange method obviates excessive lengthening of the colon and the formation of acute angulation, which may cause less pain and easier intubation during scope insertion. Recently, water exchange method was also tried in two patients undergoing SBE via antegrade route in our center. Distal ileum 8cm near to ICV and the cecum was reached respectively (unpublished data), indicating water exchange be a useful method for deep intubation of SBE.
Here a prospective, randomized, controlled trial was designed to investigate whether, compared with CO2 insufflation method, water exchange method could increase the intubation depth and diagnostic yield in patients undergoing SBE.
- Conditions
- Single Balloon Enteroscopy
- Being tested
- water exchange single balloon enteroscopy, CO2 insufflation single balloon enteroscopy, Procedural Requirements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
water exchange single balloon enteroscopyProcedure or surgery
Oral enteroscopy was performed first, followed by the anal route on the same day or later. For oral route, SBE was first advanced beyond Treitz ligation with CO2 insufflation. Then the water exchange method was used for further insertion. Briefly, residual air in the lumen was suctioned, and 37°C water was infused with a peristaltic pump through the biopsy channel to obtain lumen visualization. Turbid luminal water due to residual feces was suctioned and replaced by clean water until the small bowel lumen was clearly visualized again. Thus, infused water was removed predominantly during the insertion phase. The total volume of water was not restricted. For anal route, water exchange or CO2 insufflation method was used from the beginning of insertion respectively.
CO2 insufflation single balloon enteroscopyProcedure or surgery
Conventional enteroscopy was performed as CO2 insufflated during insertion. Oral enteroscopy was performed first, followed by the anal route on the same day or later.
Procedural RequirementsOther
SBE was advanced as deeply as possible and complete small bowel visualization was attempted. When the following conditions were met, tattooing at the deepest position with India ink was performed and the endoscope was withdrawn: no further endoscopic advancement could be achieved, detection of a significant lesion and no other lesions suspected, severe stricture, obvious sedation and SBE-related adverse events happened which required termination of further intubation.
| Study group | Role | What they receive |
|---|---|---|
| water exchange single balloon enteroscopy | Experimental | Not described Receives: Procedure: water exchange single balloon enteroscopy; Other: Procedural Requirements |
| CO2 insufflation single balloon enteroscopy | Active comparator | Not described Receives: Procedure: CO2 insufflation single balloon enteroscopy; Other: Procedural Requirements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete enteroscopy rates
Definition of total visualization of small bowel: cecum was reached via antegrade route or antrum was reached via retrograde route; submucosal india ink was observed form 2rd SBE.
Measured: up to one year
Secondary outcomes (4)
Oral insertion depth
Depth of maximal insertion is measured as follow:
- Counting folds on withdrawal---fold-counting method;
- shorten scope on Treitz ligation and deepest site.
Measured: up to one year
Diagnostic yield
Inflammatory changes Ulcer Angiodysplasia Tumor Diverticulum Others
Measured: up to one year
Procedural time
- Antegrade insertion time: From mouth to Treitz ligation From Treitz ligation to deepest point
- Retrograde insertion time:
From anus to cecum From cecum to marked or deepest site
Measured: up to one year
Adverse events
Pancreatitis Perforation Bleeding Aspiration pneumonia Post-procedural pain score accessed by 100-mm VAS (1h, 3h, 6h, 24h) Others
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startDec 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single Balloon EnteroscopyStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanglin Pan, Air Force Military Medical University, China
- Investigators
- Shuhui Liang, M.D., Principal investigator, Associated professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942863
- Sponsor's protocol ID
- 20131106-6
- Status last verified
- Mar 2016
- First submitted
- 2 Aug 2013
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Water Exchange Method on Intubation Depth and Diagnostic Yield in Patients Undergoing Single-balloon Enteroscopy: a Prospective, Randomized, Controlled, Patient-blind Trial.
- ClinicalTrials.gov ID
- NCT01942863
- Acronym / sponsor ID
- 20131106-6
- Conditions
- Single Balloon Enteroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 16 Sep 2013 (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.
Enteroscopy, including double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) and spiral enteroscopy (SE) currently, have shown good performances in small bowel diagnostics and seem to be useful in the clinical routine. However, enteroscopy is a time-consuming procedure. During common practice, large volumes of air need to be insufflated for good visualization. It leads to significant distention of the small bowel during the examination, which makes further intubation more technically challenging because of the formation of distended bowel loops and acute angulations and limits the maximal intubation length. According to the published data, the oral insertion depth of different kinds of enteroscopy is limited to approximately 240 cm. The total examination rate range form 18% to 86% for DBE and 0% to 11% for SBE.
It is thought that the intubation depth in small bowel determines the diagnostic yield and the following treatment. The deeper the enteroscopy is advanced into the small bowel, the more lesions may be found and treated. In order to improve the intubation depth of balloon enteroscopy, several methods, such as carbon dioxide insufflation and decompression side tube-equipped device, have been tried and showed positive effects. CO2 insufflation could also reduce severe pain during DBE and residual gas retention after the procedure because of rapid absorption. However, it is not known how much CO2 insufflation can decrease the distention of small bowel and the formation of bowel loops.
Recently, the use of water infusion in lieu of air insufflation has been shown to facilitate completion of colonoscopy, even in potentially difficult patients with prior abdominal or pelvic surgery. Water exchange method obviates excessive lengthening of the colon and the formation of acute angulation, which may cause less pain and easier intubation during scope insertion. Recently, water exchange method was also tried in two patients undergoing SBE via antegrade route in our center. Distal ileum 8cm near to ICV and the cecum was reached respectively (unpublished data), indicating water exchange be a useful method for deep intubation of SBE.
Here a prospective, randomized, controlled trial was designed to investigate whether, compared with CO2 insufflation method, water exchange method could increase the intubation depth and diagnostic yield in patients undergoing SBE.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| water exchange single balloon enteroscopy | Experimental | Procedure: water exchange single balloon enteroscopy, Other: Procedural Requirements |
| CO2 insufflation single balloon enteroscopy | Active comparator | Procedure: CO2 insufflation single balloon enteroscopy, Other: Procedural Requirements |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Suspected small-bowel disease
Key exclusion criteria (7 listed)
- Prior small-bowel surgery
- Total examination of small bowel not planned when image modalities showed
- lesions obviously located on duodenum, proximal jejunum or distal ileum
- High-risk esophageal varices
- Pregnancy or lactation
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 |
|---|---|---|
| water exchange single balloon enteroscopyOral enteroscopy was performed first, followed by the anal route on the same day or later. For oral route, SBE was first advanced beyond Treitz ligation with CO2 insufflation. Then the water exchange method was used for further insertion. Briefly, residual air in the lumen was suctioned, and 37°C water was infused with a peristaltic pump through the biopsy channel to obtain lumen visualization. Turbid luminal water due to residual feces was suctioned and replaced by clean water until the small bowel lumen was clearly visualized again. Thus, infused water was removed predominantly during the insertion phase. The total volume of water was not restricted. For anal route, water exchange or CO2 insufflation method was used from the beginning of insertion respectively. | Procedure or surgery | water exchange single balloon enteroscopy |
| CO2 insufflation single balloon enteroscopyConventional enteroscopy was performed as CO2 insufflated during insertion. Oral enteroscopy was performed first, followed by the anal route on the same day or later. | Procedure or surgery | CO2 insufflation single balloon enteroscopy |
| Procedural RequirementsSBE was advanced as deeply as possible and complete small bowel visualization was attempted. When the following conditions were met, tattooing at the deepest position with India ink was performed and the endoscope was withdrawn: no further endoscopic advancement could be achieved, detection of a significant lesion and no other lesions suspected, severe stricture, obvious sedation and SBE-related adverse events happened which required termination of further intubation. | Other | CO2 insufflation single balloon enteroscopy, water exchange single balloon enteroscopy |
Primary outcome
Complete enteroscopy rates
Time frame: up to one year
Definition of total visualization of small bowel: cecum was reached via antegrade route or antrum was reached via retrograde route; submucosal india ink was observed form 2rd SBE.
4 secondary outcomes
Oral insertion depth
Time frame: up to one year
Diagnostic yield
Time frame: up to one year
Procedural time
Time frame: up to one year
Adverse events
Time frame: up to 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 25 Mar 2016.
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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.
Shuhui Liang, M.D. principal investigator
Associated professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing water exchange single balloon enteroscopy, CO2 insufflation single balloon enteroscopy and Procedural Requirements in people with Single Balloon Enteroscopy, run by Air Force Military Medical University, China at 2 sites in China.
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 7 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 25 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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.
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?
Complete enteroscopy rates (time frame: up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2016.