Trial Outcomes & Findings for Rectal Indomethacin to Prevent Post ESWL-pancreatitis (NCT NCT02797067)

Last Updated: 2022-05-26

Results Overview

Patients were identified as post-ESWL pancreatitis if meeting two out of three criteria: pain consistent with acute pancreatitis; amylase or lipase\>3 times normal limit; characteristic findings on imaging, in according to the Revised Atlanta International consensus.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1370 participants

Primary outcome timeframe

up to 1 months

Results posted on

2022-05-26

Participant Flow

Participant milestones

Participant milestones
Measure	Indomethacin Subjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL. indomethacin suppository: 100mg rectal indomethacin 30min before ESWL	Glycerin Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL. Glycerin Suppository: 30min before ESWL
Overall Study STARTED	685	685
Overall Study COMPLETED	685	685
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rectal Indomethacin to Prevent Post ESWL-pancreatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Indomethacin n=685 Participants Subjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL. indomethacin suppository: 100mg rectal indomethacin 30min before ESWL	Glycerin n=685 Participants Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL. Glycerin Suppository: 30min before ESWL	Total n=1370 Participants Total of all reporting groups
Age, Continuous	44.85 years STANDARD_DEVIATION 12.32 • n=99 Participants	45.84 years STANDARD_DEVIATION 12.43 • n=107 Participants	45.35 years STANDARD_DEVIATION 12.38 • n=206 Participants
Sex: Female, Male Female	194 Participants n=99 Participants	197 Participants n=107 Participants	391 Participants n=206 Participants
Sex: Female, Male Male	491 Participants n=99 Participants	488 Participants n=107 Participants	979 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	685 Participants n=99 Participants	685 Participants n=107 Participants	1370 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) White	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants

PRIMARY outcome

Timeframe: up to 1 months

Outcome measures

Outcome measures
Measure	Indomethacin n=685 Participants Subjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL. indomethacin suppository: 100mg rectal indomethacin 30min before ESWL	Glycerin n=685 Participants Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL. Glycerin Suppository: 30min before ESWL
the Incidence of Post-ESWL Pancreatitis	60 Participants	84 Participants

SECONDARY outcome

Timeframe: up to 1 months

Asymptomatic hyperamylasemia was defined as an increase in serum amylase compared with pre-ESWL levels and beyond the upper limit of the normal range but showing no related symptoms. Serum amylase will be measured in all study patients at 3 and 24 hours after the procedure and subsequently at clinical discretion. Other post-ESWL complications including bleeding, infection, steinstrasse and perforation. Bleeding is related to clinical evidence，the level of hemoglobin ( measured at 24 hours after the procedure and at clinical discretion) and treatments. Infection is related to temperature and treatment. Steinstrasse is related to abdominal pain degree and the combination of other complications. Perforation is related to treatment.

Outcome measures

Outcome measures
Measure	Indomethacin n=685 Participants Subjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL. indomethacin suppository: 100mg rectal indomethacin 30min before ESWL	Glycerin n=685 Participants Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL. Glycerin Suppository: 30min before ESWL
the Incidence and Severity of Asymptomatic Hyperamylasemia and Other Post-ESWL Complications Infection	5 Participants	13 Participants
the Incidence and Severity of Asymptomatic Hyperamylasemia and Other Post-ESWL Complications Steinstrasse	0 Participants	1 Participants
the Incidence and Severity of Asymptomatic Hyperamylasemia and Other Post-ESWL Complications Perforation	0 Participants	1 Participants
the Incidence and Severity of Asymptomatic Hyperamylasemia and Other Post-ESWL Complications Asymptomatic Hyperamylasemia	189 Participants	197 Participants
the Incidence and Severity of Asymptomatic Hyperamylasemia and Other Post-ESWL Complications Hematuria	18 Participants	25 Participants
the Incidence and Severity of Asymptomatic Hyperamylasemia and Other Post-ESWL Complications Hematemesis	9 Participants	14 Participants
the Incidence and Severity of Asymptomatic Hyperamylasemia and Other Post-ESWL Complications Melena	19 Participants	16 Participants

SECONDARY outcome

Timeframe: up to 1 months

Post-ESWL complications are also stratified as mild, moderate and severe depending mainly on the length of hospitalization and the need for invasive treatment.

Outcome measures

Outcome measures
Measure	Indomethacin n=685 Participants Subjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL. indomethacin suppository: 100mg rectal indomethacin 30min before ESWL	Glycerin n=685 Participants Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL. Glycerin Suppository: 30min before ESWL
the Severity of Post-ESWL Pancreatitis Measured as Consensus Definitions for the Major Complications of ERCP（Endoscopic Retrograde Cholangiopancreatography ） Mild	59 Participants	79 Participants
the Severity of Post-ESWL Pancreatitis Measured as Consensus Definitions for the Major Complications of ERCP（Endoscopic Retrograde Cholangiopancreatography ） Moderate	1 Participants	5 Participants
the Severity of Post-ESWL Pancreatitis Measured as Consensus Definitions for the Major Complications of ERCP（Endoscopic Retrograde Cholangiopancreatography ） Severe	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 1 months

Potential risk factors including sex, steatorrhea, pancreas divisum, frequent attack of acute pancreatitis (≥ 1/year), diabetes, CBD（common bile duct） stenosis, alcohol consumption, multiple stones, position (the 30°-right supine position) and shock wave frequency ≥100/min.These will be assess to determine whether the treatment effect differ in these pre-specified factors.

Outcome measures

Outcome data not reported

Adverse Events

Indomethacin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Glycerin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Yangyang Qian

Changhai Hospital

Phone: 13818040017

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place