Clinical trial NCT06265311: IDUS in CBD Stone Recurrence High Risk Patients
Official title: Practical Value of IDUS in Patients With High Risk of Recurrence of Common Bile Duct Stones After ERCP Lithotomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Choledocholithiasis
Cholangiopancreatography, Endoscopic Retrograde
Ultrasonography
Keywords: Choledocholithiasis
Cholangiopancreatography, Endoscopic Retrograde
Ultrasonography
Bile Ducts
Lead sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: recurrence of bile duct stone or cholangitis
timeFrame: 48 weeks
measure: need for a nasobiliary tube
timeFrame: 2 weeks
measure: need for stents
timeFrame: 4 weeks
Secondary outcomes:
measure: operation time
timeFrame: intraoperative
measure: radiation time
timeFrame: 4 weeks
measure: hospitalization cost
timeFrame: 8 weeks
measure: Questionnaire of Symptoms and conditions after ERCP
timeFrame: 8 weeks
measure: White blood cell count
timeFrame: 12 weeks
measure: Red blood cell count
timeFrame: 12 weeks
measure: Platelet count
timeFrame: 12 weeks
measure: total bilirubin, direct bilirubin
timeFrame: 12 weeks
measure: Liver function test (ALT, AST)
timeFrame: 12 weeks
measure: albumin
timeFrame: 12 weeks
measure: total protein
timeFrame: 12 weeks
measure: Gamma-glutamyl transferase (GGT) test
timeFrame: 12 weeks
measure: An alkaline phosphatase (ALP) test
timeFrame: 12 weeks
measure: whether have a resection of gallbladder checklist
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shang General Hospital
Study officials:
affiliation: Shanghai Municipal Traditional Chinese Medicine Hospital
name: Hang Zhao, PhD
role: PRINCIPAL_INVESTIGATOR
References: