Single-balloon EnteroscopySBENCT06280469
Single-operator Versus Two-operator Technique in Single-balloon Enteroscopy
A study testing Single-Balloon Enteroscopy in people with Single-balloon Enteroscopy and Operation, run by Shuhui Liang at 6 sites in China.
Trial summary
Compared to two-operator single-balloon enteroscopy, single-operator procedure not only offer better maneuverability but may also prevent prolonged examination times and potential complications caused by poor coordination between operators. Additionally, it can optimize staffing in the endoscopy suite. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Single-balloon Enteroscopy, Operation
- What is being tested?
- Single-Balloon Enteroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 6 sitesChina
- Study dates
- 1 May 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age greater than eighteen years;
- suspected small bowel disease with planned enteroscopy
Who cannot join
- patients with a history of small bowel surgery;
- patients who fail to perform bowel preparation as required;
- patients with existing esophageal varices at high risk of bleeding;
- patients not requiring a deep small-bowel examination, such as those with lesions clearly localized to the proximal jejunum, or terminal ileum;
- patients who are in extremely poor physical condition and are not suitable for general anesthesia, as defined by an ASA score greater than 3;
- pregnant or lactating women;
- patients unable to provide written informed consent.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu
Zenan Hu, 8617726962599, huzn@lzu.edu.cn
- Recruiting
The Second Hospital & Clinical Medical School, Lanzhou University
Lanzhou, Gansu
Jieqiong Hu, 8613609340785, 35521645@qq.com
- Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shannxi
Fenrong Chen, 8618092333812, fenrong502@163.com
- Recruiting
Xi'an Honghui Hospital
Xi'an, Shannxi
Yupeng Shi, 8613891893748, xjshiyupeng@163.com
- Recruiting
Xijing Hospital of Digestive Diseases
Xi'an, Shannxi
Shuhui Liang, +862084771536, liangsh@fmmu.edu.cn
- Recruiting
The Fifth Affiliated Hospital of Zunyi Medical University
Zhuhai, Guangdong
Guangchun Liang, 8613532288380, 1327247884@qq.com
About this study
Official title: Single-operator Versus Two-operator Technique in Single-balloon Enteroscopy: a Prospective, Multicenter, Non-inferiority Randomized Controlled Trial
Compared to two-operator single-balloon enteroscopy, single-operator procedure not only offer better maneuverability but may also prevent prolonged examination times and potential complications caused by poor coordination between operators. Additionally, it can optimize staffing in the endoscopy suite. However, there are no studies comparing the effects of single-operator and two-operator techniques on single-balloon enteroscopy.
Read the detailed description
Balloon-assisted enteroscopy (BAE) has been used for diagnosing and treating small bowel diseases for over two decades. Insertion depth is a key quality indicator for enteroscopy performance. Although several adjunctive techniques have been introduced to enhance insertion depth, including carbon dioxide insufflation, transparent cap attachment, and water exchange method, operator proficiency consistently remains the most critical determinant of procedural success.
Single-balloon enteroscopy (SBE), through design optimization, offers simplified operation and a shorter learning curve compared with the double-balloon enteroscopy (DBE). Nevertheless, its procedural approach has not been revised. Clinical practice guidelines recommend the conventional two-operator technique originally established for DBE. In this setting, suboptimal coordination between the endoscopist and assistant, particularly with respect to timing and force modulation during overtube advancement and withdrawal, may not only substantially compromise insertion depth but also increases the risk of procedural complications.
Single-operator enteroscopy technique has been previously described reported. Independent control of both the enteroscope and overtube by a single operator theoretically maximizes instrumental flexibility, potentially conferring significant advantages in technical maneuvers and loop reduction. Furthermore, this approach may reduce procedure duration and optimize endoscopy unit staffing efficiency. Nevertheless, whether the single-operator technique compromises enteroscopy performance-particularly insertion depth, a primary determinant of diagnostic yield-has not been rigorously evaluated.
We therefore designed a multicenter, randomized controlled non-inferiority trial to compare single-operator versus two-operator technique with respect to insertion depth and lesion detection rate during single-balloon enteroscopy.
- Conditions
- Single-balloon Enteroscopy, Operation
- Being tested
- Single-Balloon Enteroscopy
- Keywords
- single operator, two operator, enteroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Balloon EnteroscopyProcedure or surgery
Also called SBE
Insertion procedure of single-balloon enteroscopy. (1) Insert the scope. (2) Angulate the scope to hold the gut and deflate the balloon. (3) Advance the splinting tube. (4) Inflate the balloon. (5) Withdraw both the scope and splinting tube while releasing the angulation. (6) Withdraw both the scope and splinting tube to shorten the intestine. (7) Repeat these steps until the scope reaches the deep part of the small bowel.
| Study group | Role | What they receive |
|---|---|---|
| Single operator group | Experimental | Enteroscope and splinting tube are operated by one endoscopist. Receives: Procedure: Single-Balloon Enteroscopy |
| Two operator group | Experimental | Enteroscope is operated by one endoscopist and splinting tube is operated by one assistant Receives: Procedure: Single-Balloon Enteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum insertion depth
The maximum insertion position was recognized as reached when the scope could not be advanced further after 30 minutes of attempts
Measured: From enrollment to the completion of enteroscopy
Secondary outcomes (4)
Total enteroscopy
In patients with clinical indications for total enteroscopy, the procedure was defined as: (1) intubation to the ileocecal valve for oral single-balloon enteroscopy (SBE); (2) intubation to the pylorus for anal SBE; or (3) entire small-bowel visualization upon identification of the marker during the initial route via the second route.
Measured: From enrollment to the completion of enteroscopy (oral, anal, or combined dual-route examination)
Positive finding
A positive finding was made only when the lesions found could clearly explain the clinical manifestations.
Measured: From enrollment to the completion of enteroscopy
Advent events
Adverse event was defined as any event that changed the health status of patient.
Measured: From enrollment to the completion of enteroscopy within 30 days
Procedural time
including the full operative time, enteroscope insertion time, enteroscope exit time, and other relevant procedural time segments.
Measured: From enrollment to the completion of enteroscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 May 2024
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shuhui Liang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shuhui Liang, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280469
- Sponsor's protocol ID
- KY20232298-F-2
- Acronym
- SBE
- Status last verified
- Jul 2026
- First submitted
- 19 Feb 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD that underlie results in publication will be shared.
Publications
Araki A, Tsuchiya K, Okada E, Suzuki S, Oshima S, Okamoto R, Kanai T, Watanabe M. Single-operator method for double-balloon endoscopy: a pilot study. Endoscopy. 2008 Nov;40(11):936-8. doi: 10.1055/s-2008-1077545. Epub 2008 Sep 25.
PubMed 18819060Yamamoto H, Ogata H, Matsumoto T, Ohmiya N, Ohtsuka K, Watanabe K, Yano T, Matsui T, Higuchi K, Nakamura T, Fujimoto K. Clinical Practice Guideline for Enteroscopy. Dig Endosc. 2017 Jul;29(5):519-546. doi: 10.1111/den.12883. Epub 2017 Jun 9.
PubMed 28370422
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-operator Versus Two-operator Technique in Single-balloon Enteroscopy: a Prospective, Multicenter, Non-inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06280469
- Acronym / sponsor ID
- SBE / KY20232298-F-2
- Conditions
- Single-balloon Enteroscopy, Operation
- Keywords
- single operator, two operator, enteroscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Shuhui LiangUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Feb 2024 (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.
Compared to two-operator single-balloon enteroscopy, single-operator procedure not only offer better maneuverability but may also prevent prolonged examination times and potential complications caused by poor coordination between operators. Additionally, it can optimize staffing in the endoscopy suite. However, there are no studies comparing the effects of single-operator and two-operator techniques on single-balloon enteroscopy.
Detailed description
Balloon-assisted enteroscopy (BAE) has been used for diagnosing and treating small bowel diseases for over two decades. Insertion depth is a key quality indicator for enteroscopy performance. Although several adjunctive techniques have been introduced to enhance insertion depth, including carbon dioxide insufflation, transparent cap attachment, and water exchange method, operator proficiency consistently remains the most critical determinant of procedural success.
Single-balloon enteroscopy (SBE), through design optimization, offers simplified operation and a shorter learning curve compared with the double-balloon enteroscopy (DBE). Nevertheless, its procedural approach has not been revised. Clinical practice guidelines recommend the conventional two-operator technique originally established for DBE. In this setting, suboptimal coordination between the endoscopist and assistant, particularly with respect to timing and force modulation during overtube advancement and withdrawal, may not only substantially compromise insertion depth but also increases the risk of procedural complications.
Single-operator enteroscopy technique has been previously described reported. Independent control of both the enteroscope and overtube by a single operator theoretically maximizes instrumental flexibility, potentially conferring significant advantages in technical maneuvers and loop reduction. Furthermore, this approach may reduce procedure duration and optimize endoscopy unit staffing efficiency. Nevertheless, whether the single-operator technique compromises enteroscopy performance-particularly insertion depth, a primary determinant of diagnostic yield-has not been rigorously evaluated.
We therefore designed a multicenter, randomized controlled non-inferiority trial to compare single-operator versus two-operator technique with respect to insertion depth and lesion detection rate during single-balloon enteroscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single operator group | Experimental | Procedure: Single-Balloon EnteroscopyEnteroscope and splinting tube are operated by one endoscopist. |
| Two operator group | Experimental | Procedure: Single-Balloon EnteroscopyEnteroscope is operated by one endoscopist and splinting tube is operated by one assistant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age greater than eighteen years;
- suspected small bowel disease with planned enteroscopy
Key exclusion criteria (7 listed)
- patients with a history of small bowel surgery;
- patients who fail to perform bowel preparation as required;
- patients with existing esophageal varices at high risk of bleeding;
- patients not requiring a deep small-bowel examination, such as those with lesions clearly localized to the proximal jejunum, or terminal ileum;
- patients who are in extremely poor physical condition and are not suitable for general anesthesia, as defined by an ASA score greater than 3;
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 |
|---|---|---|
| Single-Balloon EnteroscopyAlso: SBEInsertion procedure of single-balloon enteroscopy. (1) Insert the scope. (2) Angulate the scope to hold the gut and deflate the balloon. (3) Advance the splinting tube. (4) Inflate the balloon. (5) Withdraw both the scope and splinting tube while releasing the angulation. (6) Withdraw both the scope and splinting tube to shorten the intestine. (7) Repeat these steps until the scope reaches the deep part of the small bowel. | Procedure or surgery | Single operator group, Two operator group |
Primary outcome
Maximum insertion depth
Time frame: From enrollment to the completion of enteroscopy
The maximum insertion position was recognized as reached when the scope could not be advanced further after 30 minutes of attempts
4 secondary outcomes
Total enteroscopy
Time frame: From enrollment to the completion of enteroscopy (oral, anal, or combined dual-route examination)
Positive finding
Time frame: From enrollment to the completion of enteroscopy
Advent events
Time frame: From enrollment to the completion of enteroscopy within 30 days
Procedural time
Time frame: From enrollment to the completion of enteroscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 18819060Araki A, Tsuchiya K, Okada E, Suzuki S, Oshima S, Okamoto R, Kanai T, Watanabe M. Single-operator method for double-balloon endoscopy: a pilot study. Endoscopy. 2008 Nov;40(11):936-8. doi: 10.1055/s-2008-1077545. Epub 2008 Sep 25.
- Background: PubMed 28370422Yamamoto H, Ogata H, Matsumoto T, Ohmiya N, Ohtsuka K, Watanabe K, Yano T, Matsui T, Higuchi K, Nakamura T, Fujimoto K. Clinical Practice Guideline for Enteroscopy. Dig Endosc. 2017 Jul;29(5):519-546. doi: 10.1111/den.12883. Epub 2017 Jun 9.
- Individual participant dataSharing planned: Yes. IPD that underlie results in publication will be shared.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-Balloon Enteroscopy in people with Single-balloon Enteroscopy and Operation, run by Shuhui Liang at 6 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 2 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuhui Liang (86-20-84771536, liangsh@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum insertion depth (time frame: From enrollment to the completion of enteroscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06280469, which also lists 2 linked publications.
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 9 Sep 2026.