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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
80
for patients with high risks of bile duct stones recurrence using IDUS during ERCP
Shang General Hospital
Shanghai, China
RECRUITINGrecurrence of bile duct stone or cholangitis
patients will be followed up for 48 weeks to record the recurrence of CBD stones or cholangitis
Time frame: 48 weeks
need for a nasobiliary tube
it's a Yes or No categorical variable to describe if the patient was placed a nasobiliary tube during ERCP
Time frame: 2 weeks
need for stents
it's a Yes or No categorical variable to describe if stents were deployed during ERCP
Time frame: 4 weeks
operation time
the time from tracheal intubation to the end of ERCP was recorded
Time frame: intraoperative
radiation time
radiation time of each patient was recorded
Time frame: 4 weeks
hospitalization cost
hospitalization cost of each patient was recorded
Time frame: 8 weeks
Questionnaire of Symptoms and conditions after ERCP
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.
Time frame: 8 weeks
White blood cell count
Routine blood test
Time frame: 12 weeks
Red blood cell count
Routine blood test
Time frame: 12 weeks
Platelet count
Routine blood test
Time frame: 12 weeks
total bilirubin, direct bilirubin
Liver function test
Time frame: 12 weeks
Liver function test (ALT, AST)
Time frame: 12 weeks
albumin
Liver function test
Time frame: 12 weeks
total protein
Liver function test
Time frame: 12 weeks
Gamma-glutamyl transferase (GGT) test
Liver function test
Time frame: 12 weeks
An alkaline phosphatase (ALP) test
Liver function
Time frame: 12 weeks
whether have a resection of gallbladder checklist
whether the patient has a resection of gallbladder after ERCP
Time frame: 48 weeks
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