Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT05068739
Recruitment Status : Recruiting
First Posted : October 6, 2021
Last Update Posted : October 6, 2021
Sponsor:
Collaborator:
Cukurova University
Information provided by (Responsible Party):
Salih Tokmak, Duzce University

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.

Condition or disease Intervention/treatment Phase
Biliary Disease Common Bile Duct Calculi Biliary Stricture Malignant Hepatobiliary Neoplasm Pancreatic Disease Procedure: PA-EMR Procedure: NKF Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Needle Knife Fistulotomy Versus Partial Ampullary Endoscopic Mucosal Resection for Difficult Biliary Cannulation
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: PA-EMR (Partial ampullary endoscopic mucosal resection)
Partial ampullary endoscopic mucosal resection
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.

Active Comparator: NKF(Needle knife fistulotomy)
Needle knife fistulotomy
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Incidence rate of complications [ Time Frame: 1 week ]
    The rate of complications (if any occur)

  2. Cannulation time [ Time Frame: 1 day ]
    Time from first contact with cannula to papillae to deep cannulation

  3. Procedure time [ Time Frame: 1 day ]
    Total procedure time



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05068739


Contacts
Layout table for location contacts
Contact: Salih Tokmak, Asisst. prof 05052532668 ext 6437 salihtokmak@duzce.edu.tr

Locations
Layout table for location information
Turkey
Duzce University School of Medicine Recruiting
Duzce, Turkey, 81620
Contact: Salih Tokmak    +905052532698    salihtokmak@duzce.edu.tr   
Sponsors and Collaborators
Duzce University
Cukurova University
Investigators
Layout table for investigator information
Study Director: Salih Tokmak, Assist. prof Duzce University
Publications:
Layout table for additonal information
Responsible Party: Salih Tokmak, Asisstant Professor, Duzce University
ClinicalTrials.gov Identifier: NCT05068739    
Other Study ID Numbers: NKF vs. PA-EMR
First Posted: October 6, 2021    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Salih Tokmak, Duzce University:
ERCP
cannulation
endoscopic sphincterotomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Diseases
Gallbladder Diseases
Gallstones
Calculi
Pathological Conditions, Anatomical
Digestive System Diseases
Biliary Tract Diseases
Cholelithiasis
Cholecystolithiasis