Cholangiopancreatography, Endoscopic Retrograde, Choledocholithiasis, Ultrasonography
Conditions
Keywords
Choledocholithiasis, Cholangiopancreatography, Endoscopic Retrograde, Ultrasonography, Bile Ducts
Brief summary
This study is designed to observed CBD stones cases with high recurrence risks applying IDUS or not during ERCP. Patients with CBD stone high recurrence risks were enrolled in this study, and prospectively randomized into IUDS group and control group during lithotomy. Operation time, radiation time, hospitalization cost, retain of nasobiliary tube, deployment of stent were recorded. Symptoms and conditions after ERCP were also followed up including blood amylase, routine blood test, abdominal pain, post-ERCP pancreatitis, resection of gallbladder, recurrence of CBD stone and onset of cholangitis.
Detailed description
Patients with CBD stone high recurrence risks were enrolled in this study, and prospectively randomized into IUDS group and control group during lithotomy. High risks were defined as diameter of CBD\>1.5cm, number of calculi\>2, and lithotripsy. Operation time, radiation time, hospitalization cost, retain of nasobiliary tube, deployment of stent were recorded. Symptoms and conditions after ERCP were also followed up including blood amylase, routine blood test, abdominal pain, post-ERCP pancreatitis, resection of gallbladder, recurrence of CBD stone and onset of cholangitis.
Interventions
PROCEDUREIDUS examination
for patients with high risks of bile duct stones recurrence using IDUS during ERCP
Sponsors
Shanghai Municipal Hospital of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 1.Clinical diagnosis of common bile duct stones 2.At least one of the following, diameter of CBD\>1.5cm, or number of calculi\>2, or lithotripsy during ercp
Exclusion criteria
* 1\. Clinical diagnosis of liver or biliary malignant tumor. 2. Clinical diagnosis of duodenal malignant tumor 3. Failure or unexpected termination of ERCP 4. Surgery history of gallbladder or bile duct.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| recurrence of bile duct stone or cholangitis | 48 weeks | patients will be followed up for 48 weeks to record the recurrence of CBD stones or cholangitis |
| need for a nasobiliary tube | 2 weeks | it's a Yes or No categorical variable to describe if the patient was placed a nasobiliary tube during ERCP |
| need for stents | 4 weeks | it's a Yes or No categorical variable to describe if stents were deployed during ERCP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| operation time | intraoperative | the time from tracheal intubation to the end of ERCP was recorded |
| radiation time | 4 weeks | radiation time of each patient was recorded |
| hospitalization cost | 8 weeks | hospitalization cost of each patient was recorded |
| Questionnaire of Symptoms and conditions after ERCP | 8 weeks | Questionnaire of symptoms and conditions after ERCP were recorded. Degree of abdominal pain and distension were recorded with a highest level of three points respectively. |
| White blood cell count | 12 weeks | Routine blood test |
| Red blood cell count | 12 weeks | Routine blood test |
| Platelet count | 12 weeks | Routine blood test |
| total bilirubin, direct bilirubin | 12 weeks | Liver function test |
| Liver function test (ALT, AST) | 12 weeks | — |
| albumin | 12 weeks | Liver function test |
| total protein | 12 weeks | Liver function test |
| Gamma-glutamyl transferase (GGT) test | 12 weeks | Liver function test |
| An alkaline phosphatase (ALP) test | 12 weeks | Liver function |
| whether have a resection of gallbladder checklist | 48 weeks | whether the patient has a resection of gallbladder after ERCP |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORHang Zhao, PhD
Shanghai Municipal Traditional Chinese Medicine Hospital
Outcome results
None listed