Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-24 @ 7:10 PM
NCT ID:
NCT02833103
Eligibility Criteria:
Inclusion Criteria:
* Chief complaint of upper right abdominal pain following LC (within 2 weeks to 6 months) at a hospital visit, but not a pain caused by surgical incision, lasting 3 to 5 minutes each time, without a history of other biliary tract operation
* No presence of intestinal obstruction as evidenced by plain abdominal X-ray, with peptic ulcer and duodenal diverticulum ruled out through barium meal examination or gastroscopy
* No other obvious abnormalities as evidenced by abdominal ultrasound B and MRCP, except for bile duct dilation
* Patients with biliary-type sphincter of Oddi dysfunction (SOD) who are classified as SOD type II (biliary-type abdominal pain accompanied by hepatic enzyme elevation or common bile duct (CBD) dilation) and SOD type III (only biliary-type abdominal pain) according to Geenen-Hogan classification criteria
Exclusion Criteria:
* Postoperative biliary calculi, benign biliary stenosis, bile duct infection, overlong residual cystic duct (\> 0.5cm), biliary tumors, etc.
* Peptic ulcer, duodenal diverticulum
* Pancreatitis, pancreatic-type SOD
* Adhesive intestinal obstruction
* Postoperative irritable bowel syndrome (IBS)
* A history of abdominal operation or other surgery
* Pregnant and lactating women
* Use of other drugs from one week after LC to enrollment, including antispasmodic drugs, analgesics, choleretic agents, calcium ion antagonists and GI motility drugs
* A history of allergy to Pinaverium Bromide / Danshu Tablets
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
69 Years
Study:
NCT02833103
Study Brief:
Protocol Section:
NCT02833103