Prevention of Post-sphincterotomy Bleeding by Endoscopic Tranexamic Acid and Sucralfate Administration: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Methods: This is a randomized clinical trial. Patients with choledocholithiasis scheduled for ERCP with EST at National Cheng Kung University Hospital and Siriraj Hospital were enrolled. The study will recruit 120 patients. After randomization, 60 patients will be classified into the intervention group and 60 into the control group. The participants will receive standard ERCP and EST for common bile duct stone removal. If immediate polypectomy bleeding occurs, the investigators will apply standard endoscopic therapy by either local injection of diluted epinephrine or heater probe coagulation. After then, the investigators will spray 2g of sucralfate powder and 1g of tranexamic acid through duodenoscopy precisely on the post-EST wound in the intervention group. All enrolled patients will be monitored for delayed bleeding for 14 days after the ERCP.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 95
Healthy Volunteers: f
View:

• Patients aged ≥ 18 years who accept ERCP and sphincterotomy for common bile duct (CBD) stone extraction

Locations
Other Locations
Taiwan
National Cheng-Kung University Hospital
RECRUITING
Tainan City
Contact Information
Primary
Hsueh-Chien Chiang, M.D.
scion456scion@gmail.com
2353535
Backup
Xi-Zhang Lin, M.D.
linxz@mail.ncku.edu.tw
2353535
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2025-07-31
Participants
Target number of participants: 120
Treatments
Experimental: Intervention group
After the EST and stone extraction, we will randomly assign the patients to either a control or an intervention group. After EST, if immediate bleeding occurs, we will apply standard endoscopic therapy by either local injection of diluted epinephrine or heater probe coagulation. After then, we will spray 1g of sucralfate powder and 0.5g of tranexamic acid powder through a duodenoscope precisely on the EST wound in the intervention group.
No_intervention: Control group
After the EST and stone extraction, we will randomly assign the patients to either a control or an intervention group. After EST, if immediate bleeding occurs, we will apply standard endoscopic therapy by either local injection of diluted epinephrine or heater probe coagulation.
Related Therapeutic Areas
Sponsors
Leads: National Cheng-Kung University Hospital

This content was sourced from clinicaltrials.gov