Clinical Trials Directory

Trials / Completed

CompletedNCT04628273

Treatment Strategy of Pancreatic Radiolucent Stone

A Prospective Cohort Study of Large Pancreatic Radiolucent Stone

Status
Completed
Phase
Study type
Observational
Enrollment
52 (actual)
Sponsor
Changhai Hospital · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

Treatment strategy of chronic pancreatitis (CP) patients with large pancreatic radiolucent stone (≥ 5mm) has not been established. We aimed to figure out clinical features and efficacy of endotherapy for large pancreatic radiolucent stone.

Detailed description

1\. Treatment strategy of CP patients with large pancreatic stone: 1. . For patients with large radiolucent stone,ERCP with balloon sphincteroplasty was performed directly to remove radiolucent stone. If ERCP intubation failed, endoscopic ultrasound-guided drainage of pancreatic duct, surgery or medication would be applied. ESWL was performed in the following situations. Frist, MPD strictures was so severe that dilation catheter can not be inserted during ERCP. Second, there was cystic dilatation in MPD and pancreatic radiolucent stone located in cystic dilatation could not be extracted by extraction balloon or basket. In the above cases, the naso-pancreatic catheterwas inserted during ERCP, and then ESWL would be performed with repeated injection of contrast medium. After ESWL, repeated washing and negative pressure drainage were performed, and at last contrast medium was injected again to make sure the stones were cleared. For patients without MPD strictures, the nasopancreatic catheter can be directly removed, otherwise the nasopancreatic duct would be cut off into a stent. 2. . For patients with large radiopaque stone, repeated P-ESWL sessions were performed, and ERCP was routinely performed 48 hours after the last P-ESWL. If ERCP intubation failed, medication or surgery would be recommended. 2\. A prospective cohort study was conducted in CP patients with large radiolucent stone. Patients with large radiopaque stone were matched as the control group, with a ratio of 1:2 according to admission time. 3\. The primary outcome was pain relief. The secondary outcomes were stone clearance, quality of life score, and changes in pancreatic exocrine and endocrine function.

Conditions

Interventions

TypeNameDescription
PROCEDUREencoscopic retrograde cholangio-pancreatography, extracorporeal shock wave lithotripsy

Timeline

Start date
2011-03-01
Primary completion
2018-12-30
Completion
2020-01-30
First posted
2020-11-13
Last updated
2020-12-02

Source: ClinicalTrials.gov record NCT04628273. Inclusion in this directory is not an endorsement.