Single-operator Versus Double-operator in Single-Balloon Enteroscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-12-31

Brief Summary

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Compared with two-person in single-balloon enteroscopy, one-person single-balloon enteroscopy has the advantages of better observation and treatment of lesions, shorter examination time, saving resources in the endoscopy room, and reducing the postoperative discomfort of the examined person, etc. However, there is no comparative study of one-person and two-person in single-balloon enteroscopy.

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Detailed Description

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The incidence rate of chronic small bowel disease in China is 6.14%. Due to the deep location, large length, tortuous shape and large free degree, the diagnosis and treatment of small bowel disease has always been a major challenge in the clinical work of gastroenterology. Although capsule endoscopy can realize the observation of the whole small intestinal mucosa, it cannot effectively observe in real time the suspicious lesions, much less treatment, and its many difficulties still need to be resolved. Enteroscopy allows for real-time, direct visualization of the small intestine and provide effective treatment, which is an important tool for the diagnosis and treatment of small intestinal diseases. The depth of small bowel insertion and whole small bowel examination rate are important indicators for evaluating enteroscopy. However, due to objective factors, such as lesion location and luminal stenosis, the depth of insertion is a better indicator of the quality of enteroscopy, which is more in line with clinical needs.Currently,the single-balloon enteroscopy, which is now more common in clinical practice, have been designed and optimized for relative ease of operation and a shorter learning curve.Compared with two-person in single-balloon enteroscopy, one-person single-balloon enteroscopy has the advantages of better observation and treatment of lesions, shorter examination time, saving resources in the endoscopy room, and reducing the postoperative discomfort of the examined person, etc. However, there is no comparative study of one-person and two-person in single-balloon enteroscopy.Therefore, we propose to conduct a multicenter, noninferiority, randomized controlled study to explore the effect of single and double operation on single balloon small bowel insertion depth, total small bowel examination rate, and lesion detection rate.

Conditions

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Single-balloon Enteroscopy Operation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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pilot group

endoscope and overtube equipped with a balloon are operated by one endoscopist.

Group Type EXPERIMENTAL

Single-Balloon Enteroscopy

Intervention Type DEVICE

The inflated balloon is supposed to fix the intestine to the endoscope system.Pushing the endoscope deeper into the small bowel with the balloon and enteroscope.

control group

endoscope is operated by one endoscopist and overtube equipped with a balloon is operated by one assistant

Group Type EXPERIMENTAL

Single-Balloon Enteroscopy

Intervention Type DEVICE

The inflated balloon is supposed to fix the intestine to the endoscope system.Pushing the endoscope deeper into the small bowel with the balloon and enteroscope.

Interventions

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Single-Balloon Enteroscopy

The inflated balloon is supposed to fix the intestine to the endoscope system.Pushing the endoscope deeper into the small bowel with the balloon and enteroscope.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* age greater than eighteen years;
* Suspected small bowel disease with proposed enteroscopy

Exclusion Criteria

* patients with a history of small bowel surgery;
* patients who fail to perform bowel preparation as required;
* patients at high risk for esophageal varices with risk of bleeding;
* patients who have not planned a deep small bowel examination before enteroscopy, such as a lesion clearly located in the duodenum, 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;
* Inability to provide written informed consent.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No