Efficacy of Prophylactic Epinephrine Solution Injection in Prevention of Delayed Post-sphincterotomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorWen-Hsin Huang

About this trial

Bleeding is the most frequently reported serious complication of endoscopic sphincterotomy, and severe bleeding has occurred in about 1% to 2% of patients. Endoscopic injection of epinephrine is the most commonly used, effective, and least expensive method for the management of post- sphincterotomy bleeding. However, the efficacy of prophylactic saline-epinephrine solution injection to prevent delayed EST bleeding when transient bleeding During ERCP has not been established.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 20 years or older.

Ability to give informed consent.

An naive major papilla.

Transient bleeding after endoscopic sphincterotomy

Disqualifiers

Prior endoscopic sphincterotomy.

Thrombocytopenia (platelets <50,000/mm3).

Liver cirrhosis (Child A-C)

CKD stage 4-5 and dialysis.

Trial design

Design model

Parallel

Treatments tested in this trial

  • epinephrine solution injection

    Procedure/Surgery

    epinephrine solution injection at least 1 ml to the post- sphincterotomy wound

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Epinephrine solution injection groupExperimental treatment 1 intervention
Group B: non-injection groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

post EST bleeding rate

delay post-sphincterotomy bleeding rate

Time frame
30 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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Wen-Hsin Huang

Lead sponsor

China Medical University Hospital

Sponsor institution