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Endoscopic Sphincterotomy vs. Balloon Dilation for Assessment of Pancreatitis

Primary Purpose

Pancreatitis

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
endoscopic sphincterotomy
balloon dilatation for 3 minutes
balloon dilatation for 6 minutes
Sponsored by
Helios Albert-Schweitzer-Klinik Northeim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatitis focused on measuring endoscopic sphincterotomy, balloon dilation, adverse events, pancreatitis, bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • independent indication for ERCP
  • age ≥ 18 years
  • patient is able to understand informed consent

Exclusion Criteria:

  • S/p sphincterotomy
  • pancreatic or CBD-stent in situ
  • pregnant patient
  • known chronic pancreatitis
  • acute pancreatitis prior to intervention

Sites / Locations

  • Department of Gastroenterology, University Medical CenterRecruiting
  • HELIOS Albert-Schweitzer Hospital NortheimRecruiting
  • HELIOS Klinikum ErfurtRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

endoscopic sphincterotomy

balloon dilatation for 3 minutes

balloon dilatation for 6 minutes

Arm Description

performing endoscopic sphincterotomy of papilla of Vater during ERCP Device: standard sphincterotome

Balloon dilatation of papilla of Vater for 3 minutes during ERCP using 10mm balloon Device: standard dilation balloon catheter (10mm size)

Balloon dilatation of papilla of Vater for 6 minutes during ERCP using 10mm balloon Device: standard dilation balloon catheter (10 mm size)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
endoscopic perforation
signs of perforation after ERCP, proven by CT scan or surgery
major bleeding
any bleeding events associated with ERCP. Drop of Hemoglobin of > 2g/dl and signs of bleeding

Full Information

First Posted
January 20, 2015
Last Updated
February 10, 2019
Sponsor
Helios Albert-Schweitzer-Klinik Northeim
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1. Study Identification

Unique Protocol Identification Number
NCT02346448
Brief Title
Endoscopic Sphincterotomy vs. Balloon Dilation for Assessment of Pancreatitis
Official Title
Endoscopic Sphincterotomy vs. Balloon Dilation for Assessment of Pancreatitis: A Prospective Randomized Multicenter Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helios Albert-Schweitzer-Klinik Northeim

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis
Keywords
endoscopic sphincterotomy, balloon dilation, adverse events, pancreatitis, bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
endoscopic sphincterotomy
Arm Type
Active Comparator
Arm Description
performing endoscopic sphincterotomy of papilla of Vater during ERCP Device: standard sphincterotome
Arm Title
balloon dilatation for 3 minutes
Arm Type
Active Comparator
Arm Description
Balloon dilatation of papilla of Vater for 3 minutes during ERCP using 10mm balloon Device: standard dilation balloon catheter (10mm size)
Arm Title
balloon dilatation for 6 minutes
Arm Type
Active Comparator
Arm Description
Balloon dilatation of papilla of Vater for 6 minutes during ERCP using 10mm balloon Device: standard dilation balloon catheter (10 mm size)
Intervention Type
Procedure
Intervention Name(s)
endoscopic sphincterotomy
Intervention Description
sphincterotomy during ERCP
Intervention Type
Procedure
Intervention Name(s)
balloon dilatation for 3 minutes
Intervention Description
balloon dilatation during ERCP using 10mm balloon
Intervention Type
Procedure
Intervention Name(s)
balloon dilatation for 6 minutes
Intervention Description
balloon dilatation during ERCP using 10mm balloon
Primary Outcome Measure Information:
Title
acute pancreatitis
Description
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
Time Frame
one to 10 days
Secondary Outcome Measure Information:
Title
severity of pancreatitis using the Imrie score system (according to Imrie et al.)
Description
assessment of severity by Imrie score: mild pancreatitis defined by Imrie score <3, severe pancreatitis if Imrie score >=3
Time Frame
one to 10 days
Title
endoscopic perforation
Description
signs of perforation after ERCP, proven by CT scan or surgery
Time Frame
one to two days
Title
major bleeding
Description
any bleeding events associated with ERCP. Drop of Hemoglobin of > 2g/dl and signs of bleeding
Time Frame
one to two days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: independent indication for ERCP age ≥ 18 years patient is able to understand informed consent Exclusion Criteria: S/p sphincterotomy pancreatic or CBD-stent in situ pregnant patient known chronic pancreatitis acute pancreatitis prior to intervention
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tobias Meister, PDDr.med.
Phone
+495551971244
Email
tobias.meister@helios-kliniken.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Meister, PDDr.med.
Organizational Affiliation
Helios Albert-Schweitzer-Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Volker Ellenrieder, ProfDr.med.
Organizational Affiliation
University Medical Center Göttingen
Official's Role
Study Director
Facility Information:
Facility Name
Department of Gastroenterology, University Medical Center
City
Göttingen
State/Province
Lower Saxony
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Volker Ellenrieder, Professor
Phone
+49551390
Email
Volker.Ellenrieder@med.uni-goettingen.de
Facility Name
HELIOS Albert-Schweitzer Hospital Northeim
City
Northeim
State/Province
Lower Saxony
ZIP/Postal Code
37154
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tobias Meister, PDDr.med.
Phone
+495551971244
Email
tobias.meister@helios-kliniken.de
Facility Name
HELIOS Klinikum Erfurt
City
Erfurt
State/Province
Thuringia
ZIP/Postal Code
99089
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens Scharf, Professor
Phone
+49361 7810
Email
jens-gerd.scharf@helios-kliniken.de
First Name & Middle Initial & Last Name & Degree
Jens Scharf, Professor

12. IPD Sharing Statement

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Endoscopic Sphincterotomy vs. Balloon Dilation for Assessment of Pancreatitis

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