IDUS in CBD Stone Recurrence High Risk Patients
- Conditions
- UltrasonographyCholangiopancreatography, Endoscopic RetrogradeCholedocholithiasis
- Interventions
- Procedure: IDUS examination
- Registration Number
- NCT06265311
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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
-
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IDUS examination during ERCP IDUS examination CBD stones cases with high recurrence risks apply IDUS during ERCP
- Primary Outcome Measures
Name Time Method 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
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 stents 4 weeks it's a Yes or No categorical variable to describe if stents were deployed during ERCP
- Secondary Outcome Measures
Name Time Method Platelet count 12 weeks Routine blood test
Liver function test (ALT, AST) 12 weeks 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.
albumin 12 weeks Liver function test
Gamma-glutamyl transferase (GGT) test 12 weeks Liver function test
White blood cell count 12 weeks Routine blood test
Red blood cell count 12 weeks Routine blood test
total bilirubin, direct bilirubin 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
total protein 12 weeks Liver function test
Trial Locations
- Locations (1)
Shang General Hospital
🇨🇳Shanghai, China