COX-2 Inhibitor to Prevent Post-ERCP Pancreatitis

NCT02964403 | Unknown Phase 4

• 1 other identifier: XJTU1AFCT-2016-008
• Study Type: interventional
• Target: 2,700
• Locations: 0 countries
• Sites: N/A

Brief Summary

Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to 30% of procedures. Since 2012, a multicenter RCT was published in NEJM, indomethacin use in high risk patients was considered a "standard" method to prevent PEP. The mechanism of indomethacin is dependent on COX-2 inhibitor. According to data, we design the project. The purpose of this study is to determine whether COX-2 inhibitor is effective on control of Post-ERCP pancreatitis.

Conditions

Pancreatitis, Acute

Keywords

COX-2; ERCP; Pancreatitis

Outcome Measures

Primary Outcomes (1)

• Post-ERCP Pancreatitis

  30 days

Secondary Outcomes (1)

• Moderate-to-severe Pancreatitis

  30 days

Study Arms (2)

Cox-2

EXPERIMENTAL

Cox-2 inhibitor ParecoxibNa 40mg pre-ERCP injection

Drug: Cox-2

Indomethacin

ACTIVE COMPARATOR

Rectal Indomethacin was administrated immediately after ERCP in high-risk patients, while average risk patients did not.

Drug: Indomethacin

Interventions

Cox-2 DRUG

Also known as: ParecoxibNa

Cox-2

Indomethacin DRUG

Also known as: NSAID

Indomethacin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing diagnostic or therapeutic ERCP

You may not qualify if:

• Unwillingness or inability to consent for the study
• Age \< 18 years old
• Intrauterine pregnancy
• Breastfeeding mother
• Standard contraindications to ERCP
• Renal failure (Cr \>1.4mg/dl=120umol/l)
• Acute pancreatitis within 72 hours
• Known pancreatic head mass
• Subject with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram
• ERCP for biliary stent removal or exchange without anticipated pancreatogram;
• Known active cardiovascular or cerebrovascular disease.
• Presence of coagulopathy before the procedure or received anticoagulation therapy within three days before the procedure;

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

MeSH Terms

Conditions

Pancreatitis

Interventions

Cyclooxygenase 1; Indomethacin; Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Prostaglandin-Endoperoxide Synthases; Multienzyme Complexes; Enzymes; Enzymes and Coenzymes; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Central Study Contacts

Zheng Wang, MD

CONTACT

0086-15902993665; wangzheng0923@126.com

Jun Lv

CONTACT

xjyfyllh@163.com; xjyfyllh@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice chief of department of HPB Surgery

Study Record Dates

• First Submitted: October 30, 2016
• First Posted: November 16, 2016
• Study Start: December 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: August 1, 2018
• Last Updated: November 16, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share