Prevention of Post-sphincterotomy Bleeding

NCT ID: NCT06107504

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-07-31

Brief Summary

Background and Aim: Endoscopic retrograde cholangiopancreatography (ERCP) and sphincterotomy (EST) are standard treatments for choledocholithiasis. However, 10% of post-EST bleeding was reported. Currently, there are no effective methods or medications for the prevention of post-EST bleeding. This study aimed to investigate whether the local administration of TXA and sucralfate can reduce the post-EST bleeding event.

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.

Detailed Description

Endoscopic retrograde cholangiopancreatography (ERCP) is an advanced endoscopic procedure combining endoscopy and fluoroscopy to diagnose and treat diseases of the pancreaticobiliary ductal system, including choledocholithiasis, biliary strictures, and cholangitis. ERCP is associated with a higher rate of complications than other endoscopic procedures, including post-ERCP pancreatitis (PEP), bleeding, perforation, and biliary tract infection. The incidence rate of ERCP-related complications has been reported at approximately 10 percent, with mortality rates ranging from 0.1 to 1.4 percent. Despite recent technological advancements and safety precautions, the ERCP procedure-related death rates have remained high.

Among all complications, delayed bleeding after sphincterotomy (EST) is a nightmare for both clinical physicians and endoscopists. Post-EST bleeding results in Tarry-bloody stool and anemia, increasing the mortality rate and hospital stay. While non-steroidal anti-inflammatory drugs (NSAIDs), pancreatic stents, and intravenous fluids can help prevent post-ERCP pancreatitis, there is no effective methodology or medication for bleeding prevention currently. Therefore, developing a prevention method for post-EST bleeding is urgent and important.

Tranexamic acid (TXA) is a well-known antifibrinolytic agent that inhibits fibrin degradation by binding to tissue plasminogen, thereby preventing blood clot lysis and reducing bleeding. A recent study evaluating the effect of topical tranexamic acid (TXA) powder on bleeding peptic ulcers demonstrated that the precise endoscopic administration of TXA powder can enhance the stop-bleeding effect.

Sucralfate, a complex of aluminum hydroxide and sucrose octa sulfate, can bind to the wound base. This protective barrier can prevent the wound from further environmental injury. Sucralfate has been widely used for wounds and ulcer treatment, e.g., skin wounds, oral ulcers, and peptic ulcers. With the protective effect of the papilla mucosa, sucralfate can cover the EST wound and has the potential to avoid further environmental damage. In combination with TXA powder in stabilizing the clotting, we expect the post-EST bleeding event will reduce. Therefore, this study aimed to investigate whether the combination therapy of topical administration of TXA and sucralfate after EST can reduce the post-EST bleeding event.

Conditions

Post-ERCP Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Sucralfate

Intervention Type: DRUG

2g of sucralfate powder and 1g of tranexamic acid powder will be sprayed after EST

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sucralfate

2g of sucralfate powder and 1g of tranexamic acid powder will be sprayed after EST

Intervention Type: DRUG

Other Intervention Names

Tranexamic acid

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Paitnets with no schedules for sphincterotomy
• Paitnets with unsuccessful CBD cannulation
• Patients with allergy to sucralfate

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cheng-Kung University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hsueh-Chien Chiang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Cheng-Kung University Hospital

Tainan City, Other (Non U.s.), Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Hsueh-Chien Chiang, M.D.

Role: CONTACT

scion456scion@gmail.com

2353535 ext. 9118

Xi-Zhang Lin, M.D.

Role: CONTACT

linxz@mail.ncku.edu.tw

2353535 ext. 9118

Facility Contacts

Hsueh-Chien Chiang, M.D.

Role: primary

scion456scion@gmail.com

2353535

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Other Identifiers

B-BR-112-038

Identifier Type: -

Identifier Source: org_study_id