Trials / Unknown
UnknownNCT03416205
A Prospective Study of Treating Duodenal Papillary Sphincter in Different Ways During ERCP
A Prospective Study of Treating Duodenal Papillary Sphincter in Different Ways During ERCP: Comparison of EST, EPBD, and sEST+EPBD in Endoscopic Choledocholithiasis Treatment.
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 450 (estimated)
- Sponsor
- Zhujiang Hospital · Academic / Other
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Endoscopic retrograde cholangiopancreatography (ERCP) is commonly performed to remove bile duct stones.Endoscopic sphincterotomy (EST), endoscopic papillary balloon dilation (EPBD), and endoscopic sphincterotomy plus balloon dilation (sEST+EPBD) are 3 methods used to enlarge the papillary orifice, but their efficacy and safety remains controversial. This study aimed to compare these methods for treating common bile duct (CBD) stones.
Detailed description
Investigators first divided the patients with different sizes of common bile duct stones into two groups. The bile duct stone diameter of group A is less than 1.0cm while group B is more than 1.0cm and less than 1.5cm. Each group compared Endoscopic sphincterotomy (EST), endoscopic papillary balloon dilation (EPBD), and endoscopic sphincterotomy plus balloon dilation (sEST+EPBD) in ERCP. Through the postoperative comparison of relevant inspection test indicators, the recovery of patients, whether the occurrence of complications, including infection,bleeding,pancreatitis,perforation , and 1 year stone recurrence rate,Investigators assess the advantages and disadvantages in three different strategies in different sizes of common bile duct stones , and finally get a relatively objective evaluation to guide our daily ERCP work on the choice of duodenal papillary sphincter treatment strategy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Erbao electric knife | Erbao electric knife is used to cut the Duodenal sphincter |
| DEVICE | Three-cavity incision knife | Three-cavity incision knife is used to cut the Duodenal sphincter |
| DEVICE | Columnar expansion balloon | Columnar expansion balloon is used to expand the the Duodenal sphincter |
Timeline
- Start date
- 2017-07-20
- Primary completion
- 2021-09-01
- Completion
- 2021-09-01
- First posted
- 2018-01-31
- Last updated
- 2018-03-19
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03416205. Inclusion in this directory is not an endorsement.