Trial Outcomes & Findings for Topical Pancreatic Duct Lidocaine for Prevention of Post-ERCP Pancreatitis (NCT NCT00953199)

Results Overview

The primary outcome of interest will be development of acute pancreatitis defined as new or worsening abdominal pain post-ERCP associated with an increase in serum amylase at least 3 times the upper limit of normal.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

506 participants

Primary outcome timeframe

24-48 hours post-procedure

Results posted on

2017-10-03

Participant Flow

March 2010 -May 2013, recruited from the endoscopy unit

Participant milestones

Participant milestones
Measure	Lidocaine Lidocaine Hydrochloride: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with lidocaine 2% (5 ml) used at ERCP. Lidocaine will only be used once, and thus a maximum dose of 100 mg will be employed. If the patient requires more contrast agent, this will be used without the addition of lidocaine.	Normal Saline Normal Saline: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with normal saline 0.9% (5 ml) used at ERCP (standard of care).
Overall Study STARTED	254	252
Overall Study COMPLETED	254	252
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Topical Pancreatic Duct Lidocaine for Prevention of Post-ERCP Pancreatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lidocaine n=254 Participants Lidocaine Hydrochloride: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with lidocaine 2% (5 ml) used at ERCP. Lidocaine will only be used once, and thus a maximum dose of 100 mg will be employed. If the patient requires more contrast agent, this will be used without the addition of lidocaine.	Normal Saline n=252 Participants Normal Saline: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with normal saline 0.9% (5 ml) used at ERCP (standard of care).	Total n=506 Participants Total of all reporting groups
Age, Continuous	56 years n=5 Participants	55.6 years n=7 Participants	55.8 years n=5 Participants
Sex: Female, Male Female	128 Participants n=5 Participants	126 Participants n=7 Participants	254 Participants n=5 Participants
Sex: Female, Male Male	126 Participants n=5 Participants	126 Participants n=7 Participants	252 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24-48 hours post-procedure

The primary outcome of interest will be development of acute pancreatitis defined as new or worsening abdominal pain post-ERCP associated with an increase in serum amylase at least 3 times the upper limit of normal.

Outcome measures

Outcome measures
Measure	Lidocaine n=254 Participants Lidocaine Hydrochloride: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with lidocaine 2% (5 ml) used at ERCP. Lidocaine will only be used once, and thus a maximum dose of 100 mg will be employed. If the patient requires more contrast agent, this will be used without the addition of lidocaine.	Normal Saline n=252 Participants Normal Saline: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with normal saline 0.9% (5 ml) used at ERCP (standard of care).
Post ERCP Pancreatitis is the Primary Outcome.	26 participants	20 participants

SECONDARY outcome

Timeframe: measurement is taken 2 hrs after ERCP

serum amylase levels are measure by a blood draw

Outcome measures

Outcome measures
Measure	Lidocaine n=254 Participants Lidocaine Hydrochloride: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with lidocaine 2% (5 ml) used at ERCP. Lidocaine will only be used once, and thus a maximum dose of 100 mg will be employed. If the patient requires more contrast agent, this will be used without the addition of lidocaine.	Normal Saline n=252 Participants Normal Saline: 1:1 combination of contrast dye Diatrizoate 60% (5 ml) diluted with normal saline 0.9% (5 ml) used at ERCP (standard of care).
Serum Amylase Levels	130 units/liter Interval 30.0 to 1826.0	128 units/liter Interval 30.0 to 4000.0

Adverse Events

Lidocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Saline

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

Abraham Mathew MD

Penn State Hershey Medical center

Phone: 717 531 3834

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place