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Use of Touch and no Touch Guide-wire Techniques for Deep Biliary Cannulation: the TNT Study (TNT)

Primary Purpose

Biliary Tract Diseases

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Guide-wire cannulation
Sphincterotome assisted guide-wire cannulation
Sponsored by
Azienda Usl di Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Tract Diseases focused on measuring Biliary cannulation, Endoscopic retrograde cholangiopancreatography, Touch guide-wire techniques, No touch guide-wire techniques

Eligibility Criteria

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

Inclusion Criteria:

  • Age 18 or older
  • Clinical symptoms, laboratory findings and radiological evidences of biliary disease
  • Willing and able to comply with the study procedures and provide written informed consent to participate in the study

Exclusion Criteria:

  • Age <18 yars
  • Patients with previous sphincterotomy
  • Patients with previous papillary endoscopic balloon dilation
  • Presence of a previously placed plastic or metal biliary stent
  • Presence of any esophageal or gastro/duodenal stent
  • Pancreatic or ampullary cancer, proven by imaging and/or cytology and/or histology, are excluded as PEP is very uncommon in these subgroups and tumour-related anatomical variation may alter cannulation technique (consider substratify results for this subgroup, but exclude if duodenal stenosis precludes an attempt on the papilla)
  • Patients with surgically altered anatomy (Bilroth II gastrectomy and Roux en Y anastomosis) are excluded as cannulation technique is fundamentally different from that in normal anatomy
  • Presence of a diverticular papilla
  • Presence of a duodenal stenosis
  • Presence of a pancreas divisum
  • Patients with contraindication to endoscopic procedures
  • Hemodinynamic instability, any acute illness or exacerbation of chronic illness, acute infections.
  • Platelet count less than 50,000/mm3 and INR no greater than 1.5 times upper limit of normal
  • Inability or refusal to give informed consent.
  • Refusal to provide consent

Sites / Locations

  • Azienda Unità Sanitaria Locale

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Touch group

No touch group

Arm Description

Sphincterotome assisted guide-wire cannulation

Guide-wire cannulation

Outcomes

Primary Outcome Measures

Cannulation success rate

Secondary Outcome Measures

Incidences of PEP

Full Information

First Posted
August 5, 2013
Last Updated
March 24, 2017
Sponsor
Azienda Usl di Bologna
Collaborators
Catania Hospital Gastroenterology, Niguarda Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01954602
Brief Title
Use of Touch and no Touch Guide-wire Techniques for Deep Biliary Cannulation: the TNT Study
Acronym
TNT
Official Title
A Multicenter Randomized Trial Comparing the Use of Touch and no Touch Guide-wire Techniques for Deep Biliary Cannulation: the TNT Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (Actual)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Usl di Bologna
Collaborators
Catania Hospital Gastroenterology, Niguarda Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The specific goal of this study is to compare the deep biliary cannulation rate and complication rates associated with use of touch and no touch guide-wire biliary cannulation techniques.
Detailed Description
The most common technique used to achieve primary deep biliary cannulation is the standard contrast-assisted method, in which a catheter or sphincterotome is introduced into the papilla in the direction of the bile duct and a contrast medium injected to confirm that the duct has been cannulated. The biliary guidewire cannulation technique consists of the introduction of a guide-wire into the bile duct instead of contrast injection as the first maneuver. The benefit of this technique, compared with classic contrast cannulation, has been demonstrated in several studies which show similar results and have been analyzed in a recent meta-analysis, including 5 studies and 1762 patients, and demonstrating that the use of the guide-wire technique significantly improved the primary cannulation rate from 74.9% to 85.3%. More importantly, significantly reduced the incidence of PEP from 8.6% to 1.6%. There are several variations of this technique; the tip of the sphincterotome is inserted initially a few millimeters through the papillary orifice and then introduce the guide-wire to the target ("touch technique"). Another variation is direct cannulation with the guide-wire hovering a few millimeters through the catheter or sphincterotome ("no touch technique"). To date, there are no randomized controlled trials comparing the two above described way to access to biliary duct regarding efficacy and rate of complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Diseases
Keywords
Biliary cannulation, Endoscopic retrograde cholangiopancreatography, Touch guide-wire techniques, No touch guide-wire techniques

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Touch group
Arm Type
Active Comparator
Arm Description
Sphincterotome assisted guide-wire cannulation
Arm Title
No touch group
Arm Type
Experimental
Arm Description
Guide-wire cannulation
Intervention Type
Procedure
Intervention Name(s)
Guide-wire cannulation
Intervention Description
Direct guide-wire hovering a few millimeters through the catheter or sphincterotome
Intervention Type
Procedure
Intervention Name(s)
Sphincterotome assisted guide-wire cannulation
Intervention Description
Sphincterotome is inserted initially a few millimeters through the papillary orifice
Primary Outcome Measure Information:
Title
Cannulation success rate
Time Frame
No more than 5 minutes of biliary cannulation or 5 unintended pancreatic duct cannulation with the guidewire, with both techniques
Secondary Outcome Measure Information:
Title
Incidences of PEP
Time Frame
from the intervention until two days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 or older Clinical symptoms, laboratory findings and radiological evidences of biliary disease Willing and able to comply with the study procedures and provide written informed consent to participate in the study Exclusion Criteria: Age <18 yars Patients with previous sphincterotomy Patients with previous papillary endoscopic balloon dilation Presence of a previously placed plastic or metal biliary stent Presence of any esophageal or gastro/duodenal stent Pancreatic or ampullary cancer, proven by imaging and/or cytology and/or histology, are excluded as PEP is very uncommon in these subgroups and tumour-related anatomical variation may alter cannulation technique (consider substratify results for this subgroup, but exclude if duodenal stenosis precludes an attempt on the papilla) Patients with surgically altered anatomy (Bilroth II gastrectomy and Roux en Y anastomosis) are excluded as cannulation technique is fundamentally different from that in normal anatomy Presence of a diverticular papilla Presence of a duodenal stenosis Presence of a pancreas divisum Patients with contraindication to endoscopic procedures Hemodinynamic instability, any acute illness or exacerbation of chronic illness, acute infections. Platelet count less than 50,000/mm3 and INR no greater than 1.5 times upper limit of normal Inability or refusal to give informed consent. Refusal to provide consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elio Jovine, MD
Organizational Affiliation
AUSL Bologna
Official's Role
Study Chair
Facility Information:
Facility Name
Azienda Unità Sanitaria Locale
City
Bologna
ZIP/Postal Code
40100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
10536317
Citation
Rabenstein T, Schneider HT, Nicklas M, Ruppert T, Katalinic A, Hahn EG, Ell C. Impact of skill and experience of the endoscopist on the outcome of endoscopic sphincterotomy techniques. Gastrointest Endosc. 1999 Nov;50(5):628-36. doi: 10.1016/s0016-5107(99)80010-8.
Results Reference
background
PubMed Identifier
2070995
Citation
Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. doi: 10.1016/s0016-5107(91)70740-2.
Results Reference
background
PubMed Identifier
1889699
Citation
Sherman S, Ruffolo TA, Hawes RH, Lehman GA. Complications of endoscopic sphincterotomy. A prospective series with emphasis on the increased risk associated with sphincter of Oddi dysfunction and nondilated bile ducts. Gastroenterology. 1991 Oct;101(4):1068-75.
Results Reference
background
PubMed Identifier
8782497
Citation
Freeman ML, Nelson DB, Sherman S, Haber GB, Herman ME, Dorsher PJ, Moore JP, Fennerty MB, Ryan ME, Shaw MJ, Lande JD, Pheley AM. Complications of endoscopic biliary sphincterotomy. N Engl J Med. 1996 Sep 26;335(13):909-18. doi: 10.1056/NEJM199609263351301.
Results Reference
background
PubMed Identifier
9684657
Citation
Loperfido S, Angelini G, Benedetti G, Chilovi F, Costan F, De Berardinis F, De Bernardin M, Ederle A, Fina P, Fratton A. Major early complications from diagnostic and therapeutic ERCP: a prospective multicenter study. Gastrointest Endosc. 1998 Jul;48(1):1-10. doi: 10.1016/s0016-5107(98)70121-x.
Results Reference
background
PubMed Identifier
28527615
Citation
Bassi M, Luigiano C, Ghersi S, Fabbri C, Gibiino G, Balzani L, Iabichino G, Tringali A, Manta R, Mutignani M, Cennamo V. A multicenter randomized trial comparing the use of touch versus no-touch guidewire technique for deep biliary cannulation: the TNT study. Gastrointest Endosc. 2018 Jan;87(1):196-201. doi: 10.1016/j.gie.2017.05.008. Epub 2017 May 18.
Results Reference
derived

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Use of Touch and no Touch Guide-wire Techniques for Deep Biliary Cannulation: the TNT Study

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