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Needle Knife Fistulotomy Versus Partial Ampullary Endoscopic Mucosal Resection for Difficult Biliary Cannulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05068739
Recruitment Status : Recruiting
First Posted : October 6, 2021
Last Update Posted : October 6, 2021
Cukurova University
Information provided by (Responsible Party):
Salih Tokmak, Duzce University

Tracking Information
First Submitted Date  ICMJE September 20, 2021
First Posted Date  ICMJE October 6, 2021
Last Update Posted Date October 6, 2021
Actual Study Start Date  ICMJE June 1, 2021
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2021)
Success rate of cannulation [ Time Frame: 1 day ]
Successful bilary cannulation, verified by fluoroscopic images of correct guidewire positioning in the CBD, and contrast media.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2021)
  • Incidence rate of complications [ Time Frame: 1 week ]
    The rate of complications (if any occur)
  • Cannulation time [ Time Frame: 1 day ]
    Time from first contact with cannula to papillae to deep cannulation
  • Procedure time [ Time Frame: 1 day ]
    Total procedure time
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Needle Knife Fistulotomy Versus Partial Ampullary Endoscopic Mucosal Resection for Difficult Biliary Cannulation
Official Title  ICMJE Needle Knife Fistulotomy Versus Partial Ampullary Endoscopic Mucosal Resection for Difficult Biliary Cannulation
Brief Summary The aims of this study are to compare the needle knife fistulotomy (NKF) technique versus the partial ampullary endoscopic mucosal resection (PA-EMR) technique in patients with difficult biliary cannulation and to assess the incidence rate of complications between these cannulation methods.
Detailed Description

Cannulation success with standard techniques reported to be around 95% even in expert hands and despite all efforts, it can be challenging that needs an alternate intervention.

NKF is recommended as the initial technique for pre-cutting because the rate of post-ERCP pancreatitis (PEP) is significantly low but there is an ongoing debate about limiting its use in certain types of papillae with a long intra-mural segment

Indeed the shape of the papillae influences the success of bile duct cannulation and the choice of the pre-cutting technique. Type-2 and Type-3 papillae are more difficult to cannulate than Type-1. NKF can be performed as the initial technique for pre-cutting in protruded Type-2 and Type-3 papillae but it has some limitations.

First of all, the incision can be erratic because it is performed without a guidewire and uncontrolled. This can cause a tattered mucosa as the incision progress and the papillae lose anatomic contours. Some amount of bleeding may also unavoidably occur and the field of view further impaired. If the initial incision line is incorrect and additional incision is needed, more crumpled and deformed papillae with irregular margins may be encountered. These undesired results are frequently experienced and prevent a clean-cut, thus further complicate the cannulation. Even perforation can occur.

Recently the investigators described a novel technique, PA-EMR, for difficult biliary cannulation in patients with protruded Type-2, Type-3, and shar-pei papilla. The investigators hypothesized that with this new technique cannulation success will be higher, procedure time will be shorter and the adverse events will be lower versus NKF technique.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Biliary Disease
  • Common Bile Duct Calculi
  • Biliary Stricture
  • Malignant Hepatobiliary Neoplasm
  • Pancreatic Disease
Intervention  ICMJE
  • Procedure: PA-EMR
    Standard oval-shaped, braided wire polypectomy snare with 10 mm or 20 mm loop diameter will be used. With the duodenoscope in a semi-long position, the tip of the snare will be anchored just below the transverse fold of the ampulla and opened above-downwards fashion until the orifice will be seen. The orifice will be strictly preserved to avoid the risk of PEP and approximately the upper two-thirds of the ampullary mound will be grabbed by the snare. The direction and the depth will be controlled by combined movements of the elevator and wheels of the duodenoscope. After removal of the mucosa, the wall of choledochus will be seen clearly and standard wire-guided cannulation (WGC) will be performed. If cannulation can not be achieved with WGC, an additional incision will be performed to the wall of the choledochus with a needle knife.
  • Procedure: NKF
    The needle knife will be placed at the junction of the upper one-third and lower two-thirds of the papillary roof (bulging portion). Minimal, superficial incisions will be made in the 11-12 o'clock direction. The length of the fistulotomy will be at the endoscopist's discretion, depending on the shape of the papilla. The cut will be extended until bile juice, the pinkish bile duct mucosa, and/or the bulging of the white sphincter of the Oddi's muscle is visible.
Study Arms  ICMJE
  • Experimental: PA-EMR (Partial ampullary endoscopic mucosal resection)
    Partial ampullary endoscopic mucosal resection
    Intervention: Procedure: PA-EMR
  • Active Comparator: NKF(Needle knife fistulotomy)
    Needle knife fistulotomy
    Intervention: Procedure: NKF
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 24, 2021)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient who submitted a written informed consent for this trial, and aged between 18-90 years old
  • Patient who have naïve papilla (no previous procedure was performed at ampulla)
  • Patient who is suspected to have a biliary obstruction or biliary disease
  • Patient who is needed to have endoscopic retrograde cholangiopancreatography for treatment of biliary obstruction
  • Patient who have risks of post-endoscopic retrograde cholangiopancreatography p

Exclusion Criteria:

  • Patient who is pregnant
  • Patient with mental retardation
  • Patient allergic to contrast agents
  • Patient who received sphincterotomy or pancreatobiliary operation previously
  • Patient who have ampulla of Vater cancer
  • Patient who have difficulty for the approach to ampulla due to abdominal surgery including stomach cancer with Billroth II anastomosis
  • Patient who have pancreatic diseases as bellow (at least one more);

    • acute pancreatitis within 30days before enrollment
    • idiopathic acute recurrent pancreatitis
    • pancreas divisum
    • obstructive chronic pancreatitis
    • pancreatic cancer
  • Patients with Type-1, non-protruding Type-2 and Type-4 papilla
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 90 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Salih Tokmak, Asisst. prof 05052532668 ext 6437
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT05068739
Other Study ID Numbers  ICMJE NKF vs. PA-EMR
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Salih Tokmak, Duzce University
Study Sponsor  ICMJE Duzce University
Collaborators  ICMJE Cukurova University
Investigators  ICMJE
Study Director: Salih Tokmak, Assist. prof Duzce University
PRS Account Duzce University
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP