ERCP, Pancreatic Diseases, Bile Duct Diseases
Conditions
Keywords
ERCP, Drotaverine hydrochloride, Hyoscine-N-butylbromide
Brief summary
The aim of the present study was to evaluate the use of drotaverine hydrochloride versus hyoscine-N-butylbromide in reducing duodenal motility during diagnostic and therapeutic ERCP.
Detailed description
ERCP is an important endoscopic technique in the diagnosis and treatment of pancreatic and biliary diseases. Duodenal peristalsis can make cannulation of the papilla and the necessary therapeutic procedures difficult. Intravenous hyoscine-N-butylbromide is often used during ERCP to inhibit duodenal motility and enhance cannulation in China. However, the pharmaceutical agent is occasionally associated with serious complications such as cardiovascular events or anaphylactic shock. Hyoscine-N-butylbromide may also affect the ocular, urinary, and salivary systems. Drotaverine hydrochloride is an analogue of papaverine with smooth muscle relaxant properties. It is a non-anticholinergic antispasmodic, which selectively inhibits phosphodiesterase IV and is accompanied by a mild calcium channel-blocking effect. Adverse effects with drotaverine hydrochloride, such as hypotension, vertigo, nausea, and palpitation, are mostly mild. It can be supposed that intravenous drotaverine hydrochloride might be a feasible antimotility alternative to intravenous hyoscine-N-butylbromide in ERCP. But there is no clear evidence to recommend the use of drotaverine hydrochloride as an antispasmodic during ERCP. The aim of the present study was to evaluate the use of drotaverine hydrochloride versus hyoscine-N-butylbromide in reducing duodenal motility during diagnostic and therapeutic ERCP. The effects of drotaverine hydrochloride on facilitative cannulation and its adverse effects were also compared to hyoscine-N-butylbromide.
Interventions
Drotaverine hydrochloride 40mg was administered intravenously 15 minutes before ERCP
Hyoscine-N-butylbromide 20mg was administered intravenously 15 minutes before ERCP.
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* All patients undergoing ERCP above the age of 18 years
Exclusion criteria
* Patient with Billroth II gastrectomy * Known previous sphincterotomy * Active acute pancreatitis before ERCP * Ongoing acute cholangitis before ERCP * Hypotension (systolic blood pressure \< 100 mmHg) * Second-degree and third-degree atrioventricular block * Heart failure * Glaucoma * Obstructive uropathy * Impaired renal function (serum creatinine \> 133μmol/L) * Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Grades of the Number of Duodenal Contractions | Intra-procedure | a duodenal motility grade was determined as follows: 0 = no motility; 1 = less than five contractions/minute; 2 = 5 to 10/minute; 3 = 11 to 15/minute; 4 = continuous. |
Secondary
| Measure | Time frame |
|---|---|
| Cannulation Time | Intra-procedure |
| Percentage of Successful Selective Cannulation | Intra-procedure |
| Frequency of Post-ERCP Complications | 48 hours after ERCP |
| Side Effects | Intra-procedure and 24 hours after ERCP |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental Drotaverine hydrochloride | 325 |
| Active Comparator Hyoscine-N-butylbromide | 325 |
| Total | 650 |
Baseline characteristics
| Characteristic | Active Comparator | Experimental | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 128 Participants | 120 Participants | 248 Participants |
| Age, Categorical Between 18 and 65 years | 197 Participants | 205 Participants | 402 Participants |
| Age Continuous | 59.20 years STANDARD_DEVIATION 16.14 | 56.98 years STANDARD_DEVIATION 15.75 | 58.09 years STANDARD_DEVIATION 15.97 |
| Region of Enrollment China | 325 participants | 325 participants | 650 participants |
| Sex: Female, Male Female | 173 Participants | 139 Participants | 312 Participants |
| Sex: Female, Male Male | 152 Participants | 186 Participants | 338 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 319 | 0 / 319 |
| serious Total, serious adverse events | 0 / 319 | 0 / 319 |
Outcome results
Primary
The Grades of the Number of Duodenal Contractions
a duodenal motility grade was determined as follows: 0 = no motility; 1 = less than five contractions/minute; 2 = 5 to 10/minute; 3 = 11 to 15/minute; 4 = continuous.
Time frame: Intra-procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | The Grades of the Number of Duodenal Contractions | 1.13 scores on a scale | Standard Deviation 0.89 |
| Active Comparator | The Grades of the Number of Duodenal Contractions | 1.17 scores on a scale | Standard Deviation 0.82 |
Secondary
Cannulation Time
Time frame: Intra-procedure
Secondary
Frequency of Post-ERCP Complications
Time frame: 48 hours after ERCP
Secondary
Percentage of Successful Selective Cannulation
Time frame: Intra-procedure
Secondary
Side Effects
Time frame: Intra-procedure and 24 hours after ERCP