The effectiveness of prophylactic use of different doses of indomethacin to reduce post-ERCP pancreatitis events: a multicenter, randomized, single-blind, dose-controlled, non-inferior clinical study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100051036

Enrollment

Unknown

Registered

2021-09-10

Start date

2021-09-11

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post-ERCP pancreatitis

Interventions

Routine dose group:Rectal indomethacin 100mg

Low dose group:Rectal indomethacin 50mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients aged >=18 years; 2.Preoperative serum amylase was in the normal range; 3.Patients in the study should provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating women; 2. Those with contraindications to ERCP; 3. Those who are allergic to contrast agents and non-steroidal anti-inflammatory drugs; 4. Gastrointestinal bleeding; 5. Patients with recent acute pancreatitis and abnormal serum amylase; 6. Those who have taken non-steroidal anti-inflammatory drugs recently; 7. The patients or their family members cannot understand and cooperate with the conditions and objectives of this study; 8. Patients with mental disorders or diseases.

Design outcomes

Primary

Measure	Time frame
Pancreatitis rate after ERCP;	—

Secondary

Measure	Time frame
Severity of pancreatitis;Hemodiastase;Liver function;Renal function;	—

Countries

China

Contacts

Public ContactZhong Yunshi

Zhongshan Hospital affiliated to Fudan University

zhong.yunshi@zs-hospital.sh.cn+86 13564623481

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026