Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to learn about Efficacy of the ETGBD parallel insertion with fully covered self-expandable metal stent for preventing acute cholecystitis in patients with low cystic duct insertion.
In this study, we hypothesized that endoscopic transpapillary gallbladder drainage (ETGBD) with parallel insertion of a fully covered self-expanding metal stent(FCSEMS) through an endoscopic biliary drainage tunnel is superior in preventing complications such as cholecystitis when the gallbladder ducts confluence within the distal third of the common bile duct. And we aimed to confirm its efficacy by comparing the frequency, severity, and rate of invasive additional procedures due to cholecystitis complications to provide evidence of clinical utility.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAC-ETGBD (Prevention of Acute Cholecystitis with ETGBD) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic transpapillary gallbladder drainage (ETGBD) | Device | Fully covered self-Expandable metal stent with Endoscopic transpapillary gallbladder drainage (ETGBD) in patient with cystic duct low insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of acute cholecystitis | Diagnosis of Acute cholecystitis will be based on the Tokyo Guidelines 2018 | 2 months from the date of stent placement |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Myeong Hwan Lee, MD. | Contact | +82-10-7733-6494 | dlaudghks01@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Woo Hyun Paik, MD., PhD. | Seoul National University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D041881 | Cholecystitis, Acute |
| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided