Small Bowel DiseaseMSESBNCT04152239
Utility of Motorized Spiral Enteroscopy for Suspected Small Bowel Pathology
An observational study of Small Bowel Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Diagnosis and treatment of small bowel pathologies remain challenging due to the long length of the small bowel. Obscure gastrointestinal (GI) bleeding with negative upper and lower GI workup, suspected inflammatory bowel disease, and suspected tumors of the small bowel often require small bowel investigation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Bowel Disease
- What is being tested?
- Motorized spiral enteroscopy (MSE)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 38 participants
- Where
- 1 siteHong Kong
- Study dates
- 22 Oct 2019to 31 Jul 2023
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Consecutive patients with suspected small bowel pathology indicated for deep enteroscopy for diagnostic +/- therapeutic procedure.
Who may be able to join
- Age ≥ 18 years
- Patients with suspected small bowel pathology based on clinical presentation, small bowel imaging or capsule endoscopy indicated for diagnostic and/or therapeutic enteroscopy
- Written informed consent available
Who cannot join
- Contraindications for endoscopy due to comorbidities
- Unable to provide written informed consent
- Patients with known severe GI tract inflammation, intestinal obstruction, gastroesophageal varices that preclude a safe enteroscopy procedure
- Coagulopathy or thrombocytopenia that cannot be corrected by blood product transfusion
- Pregnant patients
- Moribund patients from terminal illnesses
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Prince of Wales Hospital, The Chinese University of Hong Kong
Shatin, New Territories
About this study
Official title: Prospective Evaluation of the Utility of Motorized Spiral Enteroscopy in Patients With Suspected Small Bowel Pathology
Diagnosis and treatment of small bowel pathologies remain challenging due to the long length of the small bowel. Obscure gastrointestinal (GI) bleeding with negative upper and lower GI workup, suspected inflammatory bowel disease, and suspected tumors of the small bowel often require small bowel investigation.
While video capsule endoscopy (VCE) and computed tomography (CT) enteroclysis (CTE) are often the initial diagnostic modalities for suspected small bowel pathologies and can provide structural information of the small bowel mucosa, biopsy or therapy for the detected pathology could not be performed with VCE or CTE. In patients who require biopsy or therapy of the detected small bowel pathology, deep enteroscopy would be the procedure of choice in modern clinical practice before subjecting patient to surgery.
Diagnostic and therapeutic deep enteroscopy can be performed by balloon overtube assisted enteroscopy (eg, double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) or spiral overtube assisted enteroscopy (SE). Despite the difference in equipment design of DBE, SBE, and SE, the concepts for small bowel intubation by pleating the intestine over the endoscope are the same behind these techniques. Depending on the location of the small bowel pathology reported by VCE or CTE, antegrade (oral route), retrograde (anal route), or combined antegrade and retrograde deep enteroscopy for total enteroscopy can be performed.
Read the detailed description
Diagnosis and treatment of small bowel pathologies remain challenging due to the long length of the small bowel. Obscure gastrointestinal (GI) bleeding with negative upper and lower GI workup, suspected inflammatory bowel disease, and suspected tumors of the small bowel often require investigations of the small bowel.
While video capsule endoscopy (VCE) and computed tomography (CT) enteroclysis (CTE) are often the initial diagnostic modalities for suspected small bowel pathologies and can provide structural information of the small bowel mucosa, biopsy or therapy for the detected pathology could not be performed with VCE or CTE. In patients who require biopsy or therapy of the detected small bowel pathology between the ligament of Treitz and ileocecal valve, deep enteroscopy would be the procedure of choice in modern clinical practice before subjecting patient to surgery.
Diagnostic and therapeutic deep enteroscopy can be performed by balloon overtube assisted enteroscopy (eg, double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) or spiral overtube assisted enteroscopy (SE)). Despite the difference in equipment design of DBE, SBE, and SE, the concept for small bowel intubation by pleating the intestine over the endoscope is the same behind these techniques. Depending on the location of the small bowel pathology reported by VCE or CTE, antegrade (oral route), retrograde (anal route), or combined antegrade and retrograde deep enteroscopy for total enteroscopy can be performed. In patients with suitable anatomy, total enteroscopy by antegrade approach alone may be achieved.
DBE was introduced in 2001 and has been the most studied form of modern deep enteroscopy. In a recent systematic review of 12823 procedures, the overall diagnostic yield was found to be 68.1%. The pooled total enteroscopy rate was 44% by the combined anterograde and retrograde approach or antegrade-only approach. The pooled minor and major adverse event (eg, perforation, bleeding, pancreatitis, aspiration pneumonia) rates were 9.1% and 0.72%, respectively. Despite its clinical utility, long procedure time (usually more than 1 to 1.5 hour) and the need for 2-operators are often regarded as drawbacks of DBE. SE was subsequently designed to address this issue with the use of a spiral overtube by manual rotation for efficient small bowel intubation. When compared to balloon overtube assisted enteroscopy, the main advantage of SE is the relative reduction in procedure time. However, the total enteroscopy rate of SE is lower, mainly due to difficult overtube and endoscope passage in retrograde procedures. Adverse events with SE (eg, minor mucosal tears, perforation, etc) have been reported to be 0.3%. Because both DBE and SE have its own shortcomings, the need to further improve the current technology of deep enteroscopy has always been present.
Recently, a motorized spiral enteroscope (MSE) (Olympus Medical, Tokyo, Japan) has become available and has the potential to address the shortcomings of the DBE and SE. MSE is an enteroscope equipped with a short spiral overtube propelled by a endoscopist-controlled motor contained in the handle of the endoscope. The endoscopist controls the left-right and up-down movements by the usual manuvers while the forward or backward advancement of the enteroscope would be contolled by a foot pedal that activates the spiral overtube rotation. The basic principle of small bowel pleating over the endoscope by the use of an overtube to achieve deep small bowel intubation is similar to that of DBE and SE. During the procedure, a visual force gauge allows the operator to monitor the direction of overtube rotation and the resistance applied to the spiral overtube in the small bowel. If excessive rotational resistance is detected, the motor would be stopped automatically to avoid mucosal trauma in the intestine. The initial experience of MSE in patients with small bowel pathology and colonic pathology appears promising with a diagnostic yield of 76 - 88%, therapeutic yield of 76%, a total enteroscopy rate of 70% (combined antegrade and retrograde approaches or antegrade alone approach) and shorter procedure time (< 40 minutes). Based on data from three studies including a total of 110 MSE procedures, no serious adverse event such as perforation has been reported. The overall adverse event rate including erosion, mucosal tear, hematoma, transient swallowing discomfort, etc, was reported to be 20% in a study with 30 patients. Despite its potential to improve the clinical management of patients with small bowel disorders, current data on the diagnostic and therapeutic utility of MSE is from expert European centers and remains limited. Investigators therefore propose this study to evaluate the utility of the MSE in patients with suspected small bowel pathology.
- Conditions
- Small Bowel Disease
- Being tested
- Motorized spiral enteroscopy (MSE)
- Keywords
- enteroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motorized spiral enteroscopy (MSE)Procedure or surgery
Endoscopic Procedures MSE is a 1.6m enteroscope equipped with a single-use short spiral overtube propelled by a user-controlled motor contained in the handle of the endoscope. The endoscopist controls the left-right and up-down movements by the usual manuvers while the forward or backward advancement of the enteroscope would be contolled by a foot pedal that activates the spiral overtube rotation. Antegrade MSE, retrograde MSE, or combined antegrade and retrograde MSE would be performed as clinically indicated for diagnostic +/- therapeutic procedures.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Study group includes consecutive patients with suspected small bowel pathology based on clinical presentation, small bowel imaging or capsule endoscopy indicated for diagnostic and/or therapeutic enteroscopy. Patients fulfilling the inclusion criteria and without exclusion criteria would undergo MSE per study protocol. Receives: Procedure: Motorized spiral enteroscopy (MSE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield
Diagnostic yield: defined as successful identification of the suspected pathology based on clinical presentation, pre-MSE small bowel imaging or capsule endoscopy
Measured: peri-procedure
Secondary outcomes (6)
Technical success
- defined as successful advancement of enteroscope beyond the ligament of Treitz for antegrade procedures, or successful advancement of enteroscope proximal to the ileocecal valve for retrograde procedures
Measured: peri-procedure
Therapeutic yield
Therapeutic yield: defined as successful endoscopic interventions such as treatment for GI bleeding, polypectomy, etc
Measured: peri-procedure
Insertion time
Insertion time: defined as time to the maximal depth of insertion in small bowel
Measured: peri-procedure
Maximal depth of insertion in small bowel
Maximal depth of insertion in small bowel
Measured: peri-procedure
Rate of total enteroscopy
Rate of total enteroscopy achieved by antegrade approach alone or combined antegrade and retrograde approaches if total enteroscopy is indicated by findings on pre-MSE small bowel imaging or capsule endoscopy
Measured: peri-procedure
Adverse events related to procedure
Adverse events related to procedure
Measured: peri-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start22 Oct 2019
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Why it stopped: Equipment was recalled by manufacturer and was no longer available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond Shing Yan Tang, Chinese University of Hong Kong
- Investigators
- Raymond Tang, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152239
- Sponsor's protocol ID
- MSE SB study
- Acronym
- MSESB
- Status last verified
- Aug 2024
- First submitted
- 2 Nov 2019
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Utility of Motorized Spiral Enteroscopy in Patients With Suspected Small Bowel Pathology
- ClinicalTrials.gov ID
- NCT04152239
- Acronym / sponsor ID
- MSESB / MSE SB study
- Conditions
- Small Bowel Disease
- Keywords
- enteroscopy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Equipment was recalled by manufacturer and was no longer available
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 5 Nov 2019 (actual)
- 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.
Diagnosis and treatment of small bowel pathologies remain challenging due to the long length of the small bowel. Obscure gastrointestinal (GI) bleeding with negative upper and lower GI workup, suspected inflammatory bowel disease, and suspected tumors of the small bowel often require small bowel investigation.
While video capsule endoscopy (VCE) and computed tomography (CT) enteroclysis (CTE) are often the initial diagnostic modalities for suspected small bowel pathologies and can provide structural information of the small bowel mucosa, biopsy or therapy for the detected pathology could not be performed with VCE or CTE. In patients who require biopsy or therapy of the detected small bowel pathology, deep enteroscopy would be the procedure of choice in modern clinical practice before subjecting patient to surgery.
Diagnostic and therapeutic deep enteroscopy can be performed by balloon overtube assisted enteroscopy (eg, double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) or spiral overtube assisted enteroscopy (SE). Despite the difference in equipment design of DBE, SBE, and SE, the concepts for small bowel intubation by pleating the intestine over the endoscope are the same behind these techniques. Depending on the location of the small bowel pathology reported by VCE or CTE, antegrade (oral route), retrograde (anal route), or combined antegrade and retrograde deep enteroscopy for total enteroscopy can be performed.
Detailed description
Diagnosis and treatment of small bowel pathologies remain challenging due to the long length of the small bowel. Obscure gastrointestinal (GI) bleeding with negative upper and lower GI workup, suspected inflammatory bowel disease, and suspected tumors of the small bowel often require investigations of the small bowel.
While video capsule endoscopy (VCE) and computed tomography (CT) enteroclysis (CTE) are often the initial diagnostic modalities for suspected small bowel pathologies and can provide structural information of the small bowel mucosa, biopsy or therapy for the detected pathology could not be performed with VCE or CTE. In patients who require biopsy or therapy of the detected small bowel pathology between the ligament of Treitz and ileocecal valve, deep enteroscopy would be the procedure of choice in modern clinical practice before subjecting patient to surgery.
Diagnostic and therapeutic deep enteroscopy can be performed by balloon overtube assisted enteroscopy (eg, double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) or spiral overtube assisted enteroscopy (SE)). Despite the difference in equipment design of DBE, SBE, and SE, the concept for small bowel intubation by pleating the intestine over the endoscope is the same behind these techniques. Depending on the location of the small bowel pathology reported by VCE or CTE, antegrade (oral route), retrograde (anal route), or combined antegrade and retrograde deep enteroscopy for total enteroscopy can be performed. In patients with suitable anatomy, total enteroscopy by antegrade approach alone may be achieved.
DBE was introduced in 2001 and has been the most studied form of modern deep enteroscopy. In a recent systematic review of 12823 procedures, the overall diagnostic yield was found to be 68.1%. The pooled total enteroscopy rate was 44% by the combined anterograde and retrograde approach or antegrade-only approach. The pooled minor and major adverse event (eg, perforation, bleeding, pancreatitis, aspiration pneumonia) rates were 9.1% and 0.72%, respectively. Despite its clinical utility, long procedure time (usually more than 1 to 1.5 hour) and the need for 2-operators are often regarded as drawbacks of DBE. SE was subsequently designed to address this issue with the use of a spiral overtube by manual rotation for efficient small bowel intubation. When compared to balloon overtube assisted enteroscopy, the main advantage of SE is the relative reduction in procedure time. However, the total enteroscopy rate of SE is lower, mainly due to difficult overtube and endoscope passage in retrograde procedures. Adverse events with SE (eg, minor mucosal tears, perforation, etc) have been reported to be 0.3%. Because both DBE and SE have its own shortcomings, the need to further improve the current technology of deep enteroscopy has always been present.
Recently, a motorized spiral enteroscope (MSE) (Olympus Medical, Tokyo, Japan) has become available and has the potential to address the shortcomings of the DBE and SE. MSE is an enteroscope equipped with a short spiral overtube propelled by a endoscopist-controlled motor contained in the handle of the endoscope. The endoscopist controls the left-right and up-down movements by the usual manuvers while the forward or backward advancement of the enteroscope would be contolled by a foot pedal that activates the spiral overtube rotation. The basic principle of small bowel pleating over the endoscope by the use of an overtube to achieve deep small bowel intubation is similar to that of DBE and SE. During the procedure, a visual force gauge allows the operator to monitor the direction of overtube rotation and the resistance applied to the spiral overtube in the small bowel. If excessive rotational resistance is detected, the motor would be stopped automatically to avoid mucosal trauma in the intestine. The initial experience of MSE in patients with small bowel pathology and colonic pathology appears promising with a diagnostic yield of 76 - 88%, therapeutic yield of 76%, a total enteroscopy rate of 70% (combined antegrade and retrograde approaches or antegrade alone approach) and shorter procedure time (< 40 minutes). Based on data from three studies including a total of 110 MSE procedures, no serious adverse event such as perforation has been reported. The overall adverse event rate including erosion, mucosal tear, hematoma, transient swallowing discomfort, etc, was reported to be 20% in a study with 30 patients. Despite its potential to improve the clinical management of patients with small bowel disorders, current data on the diagnostic and therapeutic utility of MSE is from expert European centers and remains limited. Investigators therefore propose this study to evaluate the utility of the MSE in patients with suspected small bowel pathology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Procedure: Motorized spiral enteroscopy (MSE)Study group includes consecutive patients with suspected small bowel pathology based on clinical presentation, small bowel imaging or capsule endoscopy indicated for diagnostic and/or therapeutic enteroscopy. Patients fulfilling the inclusion criteria and without exclusion criteria would undergo MSE per study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with suspected small bowel pathology indicated for deep enteroscopy for diagnostic +/- therapeutic procedure.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Patients with suspected small bowel pathology based on clinical presentation, small bowel imaging or capsule endoscopy indicated for diagnostic and/or therapeutic enteroscopy
- Written informed consent available
Key exclusion criteria (6 listed)
- Contraindications for endoscopy due to comorbidities
- Unable to provide written informed consent
- Patients with known severe GI tract inflammation, intestinal obstruction, gastroesophageal varices that preclude a safe enteroscopy procedure
- Coagulopathy or thrombocytopenia that cannot be corrected by blood product transfusion
- Pregnant patients
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 |
|---|---|---|
| Motorized spiral enteroscopy (MSE)Endoscopic Procedures MSE is a 1.6m enteroscope equipped with a single-use short spiral overtube propelled by a user-controlled motor contained in the handle of the endoscope. The endoscopist controls the left-right and up-down movements by the usual manuvers while the forward or backward advancement of the enteroscope would be contolled by a foot pedal that activates the spiral overtube rotation. Antegrade MSE, retrograde MSE, or combined antegrade and retrograde MSE would be performed as clinically indicated for diagnostic +/- therapeutic procedures. | Procedure or surgery | Study group |
Primary outcome
Diagnostic yield
Time frame: peri-procedure
Diagnostic yield: defined as successful identification of the suspected pathology based on clinical presentation, pre-MSE small bowel imaging or capsule endoscopy
6 secondary outcomes
Technical success
Time frame: peri-procedure
Therapeutic yield
Time frame: peri-procedure
Insertion time
Time frame: peri-procedure
Maximal depth of insertion in small bowel
Time frame: peri-procedure
Rate of total enteroscopy
Time frame: peri-procedure
Adverse events related to procedure
Time frame: peri-procedure
Results and safety
The study was stopped early (reason given: Equipment was recalled by manufacturer and was no longer available). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
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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.
Raymond Tang, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Bowel Disease, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 21 Aug 2024. 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 Hong Kong. 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 was stopped early (reason given: Equipment was recalled by manufacturer and was no longer available). Results are not available in the source record.
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?
Diagnostic yield (time frame: peri-procedure). 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 21 Aug 2024.