Safety and Efficacy of a Newly Developed Baby-sphincterotome for Bile Duct Cannulation

NCT01493076 | Completed

• 1 other identifier: Baby-S 2011
• Study Type: observational
• Target: 1,886
• Locations: 0 countries
• Sites: N/A

Brief Summary

Precut-sphincterotomy is a well established alternative after repeated futile attempts for common bile duct (CBD) cannulation with standard catheters and/or guide-wires fail. Commonly used devices instruments for pre-cutting are the needle-knife and the Erlangen-type precut-sphincterotome. In 1996 a so called "baby-sphincterotome" (Easy-Cut®, MTW, Wesel, Germany) with a pre-shaped-bended (to facilitate biliary access) small-calibre 3-French tip was developed, which enables cannulation and pre-cutting in one step. Here the investigators report on the clinical evaluation of this device.

Conditions

Bile Duct Diseases

Keywords

ERCP; Cannulation; Precut; Mini-spincterotome

Outcome Measures

Primary Outcomes (1)

• Number of Participants with successfull bile duct cannulation

  The baby-sphincterotome was used in patients in whom biliary sphincterotomy was clinically indicated but in whomafter standard techniques to gain biliary access had failed (study population).

  Time-to-Event Outcome Measures from the beginning of the intervention until the end of the endoscopic procedure, participants will be followed for the duration of hospital stay, an expected average of 3-5 days

Secondary Outcomes (1)

• Postinterventional compilation rate (bleeding, pancreatitis)

  Immediate or delayed complications. Time-to-Event Outcome Measures: from the beginning of the intervention till signs bleeding or panceatitis will occur. Participants will be followed for the duration of hospital stay, an expected average of 3-5 days

Study Arms (1)

Baby-S group

The baby-sphincterotome was in patients in whom biliary sphincterotomy was clinically indicated but in whom after standard techniques to gain biliary access had failed (study population).

Device: Primary cannulation/precut sphincterotomie with the Baby-S

Interventions

Primary cannulation/precut sphincterotomie with the Baby-S DEVICE

At the papilla the ankle for cannulation was optimized due to changes of the position of the sphincterotome, its lay in the working channel and the tension of the "Albaran"-lever and the cutting wire. After successful cannulation, the catheter with the sphincterotome inside was slightly pushed into the duct. If necessary, the baby-sphincterotome was replaced with a guide wire and than conventional endoscopic sphincterotomie was completed with a standard traction-type sphincterotome.

Also known as: Easy-Cut®, MTW, Wesel, Germany

Baby-S group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Use of the baby-sphincterotome for cannulation and pre-cut in cases of failed selective wire-guided bile duct access.

You may qualify if:

• Evidence for bile duct obstruction with a visible stone or tumor, dilated common bile duct \> 7 mm (or \> 9 mm in cholecystectomised patients) by ultrasonography and CT-scan or MRCP/EUS, an elevated serum bilirubin level \> 1.4 mg/dl, and serum alkaline phosphatase \> 200 U/l with clinical suspicion of obstruction without evidence for cholestatic liver disease.

You may not qualify if:

• Patients with severe coagulation disorders or distorted anatomy of the major papilla (malignant infiltration of the papilla, papillary porus not identifiable, impacted stone) and patients with former gastro-duodenal resection (e.g. BII-anatomy) were excluded

Sponsors & Collaborators

• Ruhr University of Bochum: lead

Related Publications (2)

• Foutch PG. A prospective assessment of results for needle-knife papillotomy and standard endoscopic sphincterotomy. Gastrointest Endosc. 1995 Jan;41(1):25-32. doi: 10.1016/s0016-5107(95)70272-5.

  PMID: 7698621 BACKGROUND

• Seifert H, Binmoeller KF, Schmitt T, Dietrich CF, Zipf A, Caspary WF, Wehrmann T. [A new papillotome for cannulation, pre-cut or conventional papillotomy]. Z Gastroenterol. 1999 Dec;37(12):1151-5. German.

  PMID: 10666838 BACKGROUND

MeSH Terms

Conditions

Bile Duct Diseases

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Andrea Riphaus, MD, PhD

  Ruhr University Bochum, Department of Medicine

  PRINCIPAL INVESTIGATOR

• Riphaus Andrea, MD, PhD

  Department of Medicine, Ruhr University Bochum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant medical director

Study Record Dates

• First Submitted: November 20, 2011
• First Posted: December 15, 2011
• Study Start: June 1, 2000
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 15, 2011

Record last verified: 2011-12