Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06280469
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-02-19
Brief Title:
Single-operator Versus Double-operator in Single-Balloon Enteroscopy
Sponsor:
Shuhui Liang
Organization:
Xijing Hospital of Digestive Diseases
Study Overview
Official Title:
Single-operator Versus Double-operator in Single-Balloon Enteroscopya Prospective Multicenter Non-inferiority Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SBE
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 614 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 needsCurrentlythe 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 curveCompared 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 enteroscopyTherefore 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None