Trial Outcomes & Findings for Rectal Indomethacin to Prevent Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis (NCT NCT01774604)
NCT ID: NCT01774604
Last Updated: 2016-11-04
Results Overview
Number of patients who developed pancreatitis following ERCP based on Atlanta Classification
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
449 participants
Primary outcome timeframe
From randomization to 30 days after ERCP
Results posted on
2016-11-04
Participant Flow
All patients who presented to Dartmouth-Hitchcock Medical Center for Endoscopic Retrograde Cholangiopancreatography (ERCP) for any reason between March 2013 and December 2014
Participant milestones
| Measure |
Indomethacin
Indomethacin 100 mg Per Rectum (PR) x 1 in peri-procedural period
Indomethacin: 100 mg Indomethacin PR x 1
|
Placebo
Placebo suppositories (#2)
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
223
|
226
|
|
Overall Study
COMPLETED
|
223
|
226
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rectal Indomethacin to Prevent Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
Baseline characteristics by cohort
| Measure |
Indomethacin
n=223 Participants
Indomethacin 100 mg PR x 1 in peri-procedural period
Indomethacin: 100 mg Indomethacin PR x 1
|
Placebo
n=226 Participants
Placebo suppositories (#2)
Placebo
|
Total
n=449 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.9 years
STANDARD_DEVIATION 23.7 • n=99 Participants
|
64.3 years
STANDARD_DEVIATION 15.1 • n=107 Participants
|
64.6 years
STANDARD_DEVIATION 19.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=99 Participants
|
118 Participants
n=107 Participants
|
236 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=99 Participants
|
108 Participants
n=107 Participants
|
213 Participants
n=206 Participants
|
|
Indication
Acute Cholangitis
|
12 participants
n=99 Participants
|
13 participants
n=107 Participants
|
25 participants
n=206 Participants
|
|
Indication
Choledocholithiasis
|
59 participants
n=99 Participants
|
52 participants
n=107 Participants
|
111 participants
n=206 Participants
|
|
Indication
Malignant Biliary Obstruction
|
53 participants
n=99 Participants
|
50 participants
n=107 Participants
|
103 participants
n=206 Participants
|
|
Indication
Biliary Stent Change
|
25 participants
n=99 Participants
|
25 participants
n=107 Participants
|
50 participants
n=206 Participants
|
|
Indication
Biliary Leak
|
11 participants
n=99 Participants
|
12 participants
n=107 Participants
|
23 participants
n=206 Participants
|
|
Indication
Increased Liver Tests/Jaundice
|
13 participants
n=99 Participants
|
9 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
Indication
Pancreatic Stricture
|
3 participants
n=99 Participants
|
5 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Indication
Suspected Sphincter of Oddi Dysfunction (SOD)
|
6 participants
n=99 Participants
|
8 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Indication
Pancreatic Leak/Disruption
|
11 participants
n=99 Participants
|
12 participants
n=107 Participants
|
23 participants
n=206 Participants
|
|
Indication
Pancreatic Duct Stone
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Indication
Recurrent Acute Pancreatitis
|
5 participants
n=99 Participants
|
2 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Indication
Ampullectomy
|
6 participants
n=99 Participants
|
5 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Indication
Other
|
16 participants
n=99 Participants
|
31 participants
n=107 Participants
|
47 participants
n=206 Participants
|
|
History of post-ERCP Pancreatitis
Yes
|
9 participants
n=99 Participants
|
9 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
History of post-ERCP Pancreatitis
No
|
214 participants
n=99 Participants
|
217 participants
n=107 Participants
|
431 participants
n=206 Participants
|
|
History of Previous Sphincterotomy
Yes
|
72 participants
n=99 Participants
|
71 participants
n=107 Participants
|
143 participants
n=206 Participants
|
|
History of Previous Sphincterotomy
No
|
151 participants
n=99 Participants
|
155 participants
n=107 Participants
|
306 participants
n=206 Participants
|
|
Previous ERCP
Yes
|
81 participants
n=99 Participants
|
79 participants
n=107 Participants
|
160 participants
n=206 Participants
|
|
Previous ERCP
No
|
142 participants
n=99 Participants
|
147 participants
n=107 Participants
|
289 participants
n=206 Participants
|
|
Difficult Cannulation
Yes
|
46 participants
n=99 Participants
|
42 participants
n=107 Participants
|
88 participants
n=206 Participants
|
|
Difficult Cannulation
No
|
177 participants
n=99 Participants
|
184 participants
n=107 Participants
|
361 participants
n=206 Participants
|
|
Precut Biliary Sphincterotomy
Yes
|
11 participants
n=99 Participants
|
16 participants
n=107 Participants
|
27 participants
n=206 Participants
|
|
Precut Biliary Sphincterotomy
No
|
212 participants
n=99 Participants
|
210 participants
n=107 Participants
|
422 participants
n=206 Participants
|
|
Therapeutic Biliary Sphincterotomy
Yes
|
106 participants
n=99 Participants
|
114 participants
n=107 Participants
|
220 participants
n=206 Participants
|
|
Therapeutic Biliary Sphincterotomy
No
|
117 participants
n=99 Participants
|
112 participants
n=107 Participants
|
229 participants
n=206 Participants
|
|
Therapeutic Pancreatic Sphincterotomy
Yes
|
12 participants
n=99 Participants
|
5 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
Therapeutic Pancreatic Sphincterotomy
No
|
211 participants
n=99 Participants
|
221 participants
n=107 Participants
|
432 participants
n=206 Participants
|
|
Minor Duct Sphincterotomy
Yes
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Minor Duct Sphincterotomy
No
|
218 participants
n=99 Participants
|
222 participants
n=107 Participants
|
440 participants
n=206 Participants
|
|
Balloon Dilation of Biliary Sphincter
Yes
|
21 participants
n=99 Participants
|
20 participants
n=107 Participants
|
41 participants
n=206 Participants
|
|
Balloon Dilation of Biliary Sphincter
No
|
202 participants
n=99 Participants
|
206 participants
n=107 Participants
|
408 participants
n=206 Participants
|
|
Wire Cannulation of Pancreatic Duct
Yes
|
90 participants
n=99 Participants
|
89 participants
n=107 Participants
|
179 participants
n=206 Participants
|
|
Wire Cannulation of Pancreatic Duct
No
|
133 participants
n=99 Participants
|
137 participants
n=107 Participants
|
270 participants
n=206 Participants
|
|
Pancreatography
Yes
|
50 participants
n=99 Participants
|
49 participants
n=107 Participants
|
99 participants
n=206 Participants
|
|
Pancreatography
No
|
173 participants
n=99 Participants
|
177 participants
n=107 Participants
|
350 participants
n=206 Participants
|
|
Pancreatic Acinarization
Yes
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Pancreatic Acinarization
No
|
218 participants
n=99 Participants
|
222 participants
n=107 Participants
|
440 participants
n=206 Participants
|
|
Biliary Strent Placement
Yes
|
89 participants
n=99 Participants
|
84 participants
n=107 Participants
|
173 participants
n=206 Participants
|
|
Biliary Strent Placement
No
|
134 participants
n=99 Participants
|
142 participants
n=107 Participants
|
276 participants
n=206 Participants
|
|
Pancreatic Stent Placement
Yes
|
36 participants
n=99 Participants
|
35 participants
n=107 Participants
|
71 participants
n=206 Participants
|
|
Pancreatic Stent Placement
No
|
187 participants
n=99 Participants
|
191 participants
n=107 Participants
|
378 participants
n=206 Participants
|
|
Trainee Involvement
Yes
|
152 participants
n=99 Participants
|
168 participants
n=107 Participants
|
320 participants
n=206 Participants
|
|
Trainee Involvement
No
|
71 participants
n=99 Participants
|
58 participants
n=107 Participants
|
129 participants
n=206 Participants
|
|
Concomitant Endoscopic Ultrasound with Fine Needle Aspiration (EUS/FNA)
Yes
|
41 participants
n=99 Participants
|
40 participants
n=107 Participants
|
81 participants
n=206 Participants
|
|
Concomitant Endoscopic Ultrasound with Fine Needle Aspiration (EUS/FNA)
No
|
182 participants
n=99 Participants
|
186 participants
n=107 Participants
|
368 participants
n=206 Participants
|
|
Periprocedural Fluid Volume
|
705 Milliliters
STANDARD_DEVIATION 335 • n=99 Participants
|
703 Milliliters
STANDARD_DEVIATION 355 • n=107 Participants
|
704 Milliliters
STANDARD_DEVIATION 345 • n=206 Participants
|
PRIMARY outcome
Timeframe: From randomization to 30 days after ERCPPopulation: Patient who randomized into the study and received either rectal indomethacin or placebo
Number of patients who developed pancreatitis following ERCP based on Atlanta Classification
Outcome measures
| Measure |
Indomethacin
n=223 Participants
Indomethacin 100 mg PR x 1 in peri-procedural period
Indomethacin: 100 mg Indomethacin PR x 1
|
Placebo
n=226 Participants
Placebo suppositories (#2)
Placebo
|
|---|---|---|
|
Number of Patients Who Developed Acute Pancreatitis
|
16 participants
|
11 participants
|
SECONDARY outcome
Timeframe: From randomization to 30 days after ERCPPopulation: Assess the number of patients who developed severe acute pancreatitis
Number of patients with severe acute pancreatitis based on the Atlanta Classification
Outcome measures
| Measure |
Indomethacin
n=223 Participants
Indomethacin 100 mg PR x 1 in peri-procedural period
Indomethacin: 100 mg Indomethacin PR x 1
|
Placebo
n=226 Participants
Placebo suppositories (#2)
Placebo
|
|---|---|---|
|
Number of Patients Who Developed Severe Pancreatitis
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: From randomization to 30 days after ERCPNumber of patients with moderately severe pancreatitis based on Atlanta Classification
Outcome measures
| Measure |
Indomethacin
n=223 Participants
Indomethacin 100 mg PR x 1 in peri-procedural period
Indomethacin: 100 mg Indomethacin PR x 1
|
Placebo
n=226 Participants
Placebo suppositories (#2)
Placebo
|
|---|---|---|
|
Number of Patients Who Developed Moderately Severe Pancreatitis
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: From randomization to 30 days after ERCPNumber of patient who developed mild acute pancreatitis based on the Atlanta Classification
Outcome measures
| Measure |
Indomethacin
n=223 Participants
Indomethacin 100 mg PR x 1 in peri-procedural period
Indomethacin: 100 mg Indomethacin PR x 1
|
Placebo
n=226 Participants
Placebo suppositories (#2)
Placebo
|
|---|---|---|
|
Number of Patients Who Developed Mild Pancreatitis
|
16 participants
|
9 participants
|
SECONDARY outcome
Timeframe: From randomization to 30 days after ERCPNumber of patients who developed any type of gastrointestinal bleeding from time of ERCP to 30 days post procedure
Outcome measures
| Measure |
Indomethacin
n=223 Participants
Indomethacin 100 mg PR x 1 in peri-procedural period
Indomethacin: 100 mg Indomethacin PR x 1
|
Placebo
n=226 Participants
Placebo suppositories (#2)
Placebo
|
|---|---|---|
|
Number of Patients Who Developed Gastrointestinal Bleeding
|
4 participants
|
6 participants
|
SECONDARY outcome
Timeframe: From randomization to 30 days after ERCPNumber of patients who died from any cause from the time of ERCP until 30 days post-procedure
Outcome measures
| Measure |
Indomethacin
n=223 Participants
Indomethacin 100 mg PR x 1 in peri-procedural period
Indomethacin: 100 mg Indomethacin PR x 1
|
Placebo
n=226 Participants
Placebo suppositories (#2)
Placebo
|
|---|---|---|
|
Number of Patient Deaths
|
0 participants
|
3 participants
|
SECONDARY outcome
Timeframe: From randomization until 30 days after ERCPNumber of patients admitted to the hospital for any cause following ERCP
Outcome measures
| Measure |
Indomethacin
n=223 Participants
Indomethacin 100 mg PR x 1 in peri-procedural period
Indomethacin: 100 mg Indomethacin PR x 1
|
Placebo
n=226 Participants
Placebo suppositories (#2)
Placebo
|
|---|---|---|
|
Number of Patients With 30 Days Hospital Re-admission
|
31 participants
|
20 participants
|
Adverse Events
Indomethacin
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Indomethacin
n=223 participants at risk
Indomethacin 100 mg PR x 1 in peri-procedural period
Indomethacin: 100 mg Indomethacin PR x 1
|
Placebo
n=226 participants at risk
Placebo suppositories (#2)
Placebo
|
|---|---|---|
|
Gastrointestinal disorders
Severe Acute Pancreatitis Leading to Death
|
0.00%
0/223 • From randomization to 30 days after ERCP
|
0.44%
1/226 • Number of events 1 • From randomization to 30 days after ERCP
|
|
Gastrointestinal disorders
Secondary Bacterial Peritonitis due to Multifocal Hepatocellular Carcinoma Leading to Death
|
0.00%
0/223 • From randomization to 30 days after ERCP
|
0.44%
1/226 • Number of events 1 • From randomization to 30 days after ERCP
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration Post-Procedure Leading to Death
|
0.00%
0/223 • From randomization to 30 days after ERCP
|
0.44%
1/226 • Number of events 1 • From randomization to 30 days after ERCP
|
Other adverse events
| Measure |
Indomethacin
n=223 participants at risk
Indomethacin 100 mg PR x 1 in peri-procedural period
Indomethacin: 100 mg Indomethacin PR x 1
|
Placebo
n=226 participants at risk
Placebo suppositories (#2)
Placebo
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal Bleeding
|
1.8%
4/223 • Number of events 4 • From randomization to 30 days after ERCP
|
2.7%
6/226 • Number of events 6 • From randomization to 30 days after ERCP
|
Additional Information
John M. Levenick
Penn State Hershey Medical Center/Dartmouth-Hitchcock Medical Center
Phone: 603-667-1332
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place