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One of the major elements of successful endoscopic retrograde cholangiopancreatography ( ERCP) is the timely and uncomplicated cannulation of the common bile duct (CBD) . Various factors may adversely affect the cannulation procedure of the CBD leading to complications (acute pancreatitis after ERCP, perforation of the duodenum , bleeding ). Endoscopic sphincterotomy is frequently required for interventional procedures (eg stone extraction). During sphincterotomy, incision of the orifice of the papilla will be performed by using a sphincterotome. Complications due to sphincterotomy are known: Bleeding, increased rates of acute pancreatitis, small bowel perforation and scarring with consecutive stenosis of the papilla. As an alternative to sphincterotomy, balloon dilatation using balloon catheters can be performed. As a result, bleeding complications and scarring as late effects might be prevented. Current data is limited in terms of the risk of acute pancreatitis after ERCP when using a balloon catheter.
This study aims to evaluate the incidence of acute pancreatitis and other complications after ERCP. Balloon dilatation of the papilla will be prospectively compared with endoscopic sphincterotomy in a randomized multicenter setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| endoscopic sphincterotomy | Active Comparator | performing endoscopic sphincterotomy of papilla of Vater during ERCP Device: standard sphincterotome |
|
| balloon dilatation for 3 minutes | Active Comparator | Balloon dilatation of papilla of Vater for 3 minutes during ERCP using 10mm balloon Device: standard dilation balloon catheter (10mm size) |
|
| balloon dilatation for 6 minutes | Active Comparator | Balloon dilatation of papilla of Vater for 6 minutes during ERCP using 10mm balloon Device: standard dilation balloon catheter (10 mm size) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic sphincterotomy | Procedure | sphincterotomy during ERCP |
| |
| Measure | Description | Time Frame |
|---|---|---|
| acute pancreatitis | Definition of acute pancreatitis: Serum lipase or amylase obtained 2 to 6 hours following ERCP + onset of abdominal pain after ERCP persisting for 24h+ need for analgesia | one to 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| severity of pancreatitis using the Imrie score system (according to Imrie et al.) | assessment of severity by Imrie score: mild pancreatitis defined by Imrie score <3, severe pancreatitis if Imrie score >=3 | one to 10 days |
| endoscopic perforation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tobias Meister, PDDr.med. | Contact | +495551971244 | tobias.meister@helios-kliniken.de |
| Name | Affiliation | Role |
|---|---|---|
| Tobias Meister, PDDr.med. | Helios Albert-Schweitzer-Hospital | Study Director |
| Volker Ellenrieder, ProfDr.med. | University Medical Center Göttingen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology, University Medical Center | Recruiting | Göttingen | Lower Saxony | 37075 | Germany |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016717 | Sphincterotomy, Endoscopic |
| ID | Term |
|---|---|
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D016099 | Endoscopy, Gastrointestinal |
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| balloon dilatation for 3 minutes |
| Procedure |
balloon dilatation during ERCP using 10mm balloon |
|
| balloon dilatation for 6 minutes | Procedure | balloon dilatation during ERCP using 10mm balloon |
|
signs of perforation after ERCP, proven by CT scan or surgery
| one to two days |
| major bleeding | any bleeding events associated with ERCP. Drop of Hemoglobin of > 2g/dl and signs of bleeding | one to two days |
| HELIOS Albert-Schweitzer Hospital Northeim | Recruiting | Northeim | Lower Saxony | 37154 | Germany |
|
| HELIOS Klinikum Erfurt | Recruiting | Erfurt | Thuringia | 99089 | Germany |
|
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |
| D000074432 | Sphincterotomy |
| D000074433 | Myotomy |