Clinical trial NCT06280469: Single-operator Versus Double-operator in Single-Balloon Enteroscopy
Official title: Single-operator Versus Double-operator in Single-Balloon Enteroscopy：a Prospective, Multicenter, Non-inferiority, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Single-balloon Enteroscopy
Operation
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum insertion depth
timeFrame: up to 2 years
Secondary outcomes:
measure: Total enteroscopy rate
timeFrame: up to 2 years
measure: Positive findings
timeFrame: up to 2 years
measure: Advent events
timeFrame: up to 2 years
measure: procedural time
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases
Study officials:
References:
citation: Li X, Zhao YJ, Dai J, Li XB, Xue HB, Zhang Y, Xiong GS, Ohtsuka K, Gao YJ, Liu Q, Song Y, Fang JY, Ge ZZ. Carbon dioxide insufflation improves the intubation depth and total enteroscopy rate in single-balloon enteroscopy: a randomised, controlled, double-blind trial. Gut. 2014 Oct;63(10):1560-5. doi: 10.1136/gutjnl-2013-306069. Epub 2014 Mar 13.