Combination of Rectal Indomethacin and Pancreatic Duct Stenting Versus Indomethacin Alone in Preventing PEP

Air Force Military Medical University of People's Liberation Army

Status: Completed

Conditions: Healthy

Treatments: Device: Pancreatic duct stenting

Study type: Observational

Funder types: Other

Identifiers

NCT04340687

20191115-2

Details and patient eligibility

About

Rectal indomethacin and pancreatic duct (PD) stenting (PDS) are recommended for the prevention of post-ERCP pancreatitis (PEP). However, the effects of the combination of the two methods on preventing PEP are controversial. We hypothesized that some group of patients with difficult cannulation might benefit from the combination of indomethacin plus PDS (IP) compared with indomethacin alone (IN).

Enrollment: 664 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients underwent diagnostic or therapeutic ERCP
2. With native papilla
3. With difficult cannulation (cannulation time >10min or cannulation attempts >5 times or inadvertently PD cannulation ≥1)
4. Receiving post-ERCP rectal indomethacin

Exclusion criteria

1. Patients with indications of PD cannulation
2. No attempt of cannulation due to inaccessible papilla
3. Non-difficult cannulation

Trial design

664 participants in 2 patient groups

IP group

Description:

All patients recevied pancreatic duct stent during ERCP and one single dose of 100mg rectal indomethacin after ERCP.

Treatment:

Device: Pancreatic duct stenting

IN group

Description:

All patients received one single dose of 100mg rectal indomethacin after ERCP.