Prevention of pancreatic inflammation after endoscopy of the pancreas and bile duct with anti-inflammatory

Acute pancreatitis prevention after endoscopic retrograde cholangiopancreatography (ERCP) with anti-inflammatory

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-6zkm5k

Enrollment

Unknown

Registered

2015-12-29

Start date

2014-03-30

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

acute pancreatitis

Interventions

Experimental group: 137 patients referred to undergo endoscopy of the pancreas and bile duct (i.e., endoscopic retrograde cholangiopancreatography) will receive intravenous infusion containing 100mL o

Drug

D27.505.954.158

D02.241.223.701.480

Eligibility

Age

18 Years to 95 Years

Inclusion criteria

Inclusion criteria: Eligible subjects were all adults who were scheduled to undergo ERCP at our institution.

Exclusion criteria

Exclusion criteria: Exclusion criteria were patients with known contraindication to ketoprofen use, active pancreatitis at the time of ERCP, previous ERCP and refusal to enter in the study.

Design outcomes

Primary

Measure	Time frame
Acute post-ERCP pancreatitis, defined by the complaint of abdominal pain, said by phone contact 48 hours after the procedure - in the post-ERCP evaluation form (attached) - associated with increased serum amylase and lipase, at least three times the upper limit of normal or imaging (abdominal ultrasound, abdominal CT scan or abdominal MRI) typical of acute pancreatitis. ;We registered 10 cases of acute pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP), 5 cases in the experimental group and 5 in the control group (p equal to 1). It was also observed 38 cases of abdominal pain without acute pancreatitis, 23 cases in the control group and 15 cases in the experimental group (p equal to 0.33).	—

Measure

Time frame

Acute post-ERCP pancreatitis, defined by the complaint of abdominal pain, said by phone contact 48 hours after the procedure - in the post-ERCP evaluation form (attached) - associated with increased serum amylase and lipase, at least three times the upper limit of normal or imaging (abdominal ultrasound, abdominal CT scan or abdominal MRI) typical of acute pancreatitis. ;We registered 10 cases of acute pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP), 5 cases in the experimental group and 5 in the control group (p equal to 1). It was also observed 38 cases of abdominal pain without acute pancreatitis, 23 cases in the control group and 15 cases in the experimental group (p equal to 0.33).

—

Secondary

Measure	Time frame
Adverse effects of ketoprofen and frequency of complications (infection, perforation, bleeding) after the procedure, evaluated by post-endoscopic retrograde cholangiopancreatography (ERCP) evaluation (attached).;There were no adverse effects related to the use of ketoprofen. Four cases of infection were observed: 1 case in the experimental group and 3 cases in the control group (p equal to 0.62). Perforation occurred in 1 case in the control group only (p equal to 1). Bleeding was observed in 8 cases, 4 cases in each group (p equal to 1).	—

Measure

Time frame

Adverse effects of ketoprofen and frequency of complications (infection, perforation, bleeding) after the procedure, evaluated by post-endoscopic retrograde cholangiopancreatography (ERCP) evaluation (attached).;There were no adverse effects related to the use of ketoprofen. Four cases of infection were observed: 1 case in the experimental group and 3 cases in the control group (p equal to 0.62). Perforation occurred in 1 case in the control group only (p equal to 1). Bleeding was observed in 8 cases, 4 cases in each group (p equal to 1).

—

Countries

Brazil

Contacts

Public ContactFernanda de Quadros Onófrio

Universidade Federal de Ciências da Saúde de Porto Alegre

fqonofrio@gmail.com+55(51)80226194

Outcome results

None listed

Source: REBEC (via WHO ICTRP)