Suspected Biliary Dysfunction of sphincter
Conditions
Interventions
Group 1:Endoscopic sphincterotomy
Group 2:Endoscopic sphincterotomy and endoscopic papillary balloon dilation
Group 3:Endoscopic sphincterotomy and endoscopic metal biliary endoprothesis
Sponsors
Shanghai East Hospital, Tongji University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Must have an episode of abdominal pain in the upper abdomen and/or upper right abdomen, and meet all the following conditions: (1)Builds up to a steady level and lasting 30 minutes or longer; (2)Occurring at different intervals (not daily); (3)Severe enough to interrupt daily activities or lead to an emergency department visit; (4)Not significantly (<20%) related to bowel movements; (5)Not significantly (<20%) relieved by postural; (6)Elevated liver enzymes or dilated bile duct, but not both; (7)Absence of bile duct stones or other structural abnormalities. 2. Support the diagnostic criteria: pain accompanied by one or more of the following: (1)Nausea and vomiting; (2)Radiation to the back and/or right infrasubscapular region; (3)Waking from sleep; (4)Normal amylase/lipase; (5)Abnormal sphincter of Oddi manometry; (6)Hepatobiliary scintigraphy.
Exclusion criteria
Exclusion criteria: 1. Upper abdominal and/or right upper abdominal pain due to acute pancreatitis, cholecystitis, gallstones, bile duct stones, liver abscesses, ileus, ulcers, abdominal tumors, and other causes; 2. Accompanied by blood diseases, severe infection and severe liver (ALT>3 x ULN), kidney (Scr>2ULN), abnormal cardiac function (NYHA III or IV); 3. Consciousness disorder, mental illness, cognitive decline and other diseases that may affect informed consent and evaluation of research results; 4. History of malignant tumor or concomitant tumor found after this visit; 5. Pregnant and lactating women or women who have fertility requirements within 12 months; 6. Concomitant immunodeficiency disease or autoimmune disease; 7. The life expectancy is less than 2 years or the study cannot be completed for other reasons; 8. Patients who participated in other clinical trials within 6 months; 9. Patients who have received endoscopic intervention within six months after onset of the disease; 10. There are metal implants or other reasons in the body that cannot tolerate magnetic resonance examination; 11. Unwilling to sign informed consent or unable to be followed up regularly; 12. Other conditions determined by the researcher not suitable for inclusion in the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recurrent abdominal pain intensity and disability (RAPID) instrument; | — |
Secondary
| Measure | Time frame |
|---|---|
| visual analogy score (VAS) of pain releasing;liver function;the diameter of common bile duct; | — |
Countries
China
Contacts
Public ContactZhu Feng
Shanghai East Hospital, Tongji University School of Medicine
Outcome results
None listed