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

NCT05068739 | Completed

• 1 other identifier: NKF vs. PA-EMR
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Disease; Common Bile Duct Calculi; Biliary Stricture; Malignant Hepatobiliary Neoplasm; Pancreatic Disease

Keywords

ERCP; cannulation; endoscopic sphincterotomy

Outcome Measures

Primary Outcomes (1)

• Success rate of cannulation

  Successful bilary cannulation, verified by fluoroscopic images of correct guidewire positioning in the CBD, and contrast media.

  1 day

Secondary Outcomes (3)

• Incidence rate of complications

  1 week

• Cannulation time

  1 day

• Procedure time

  1 day

Study Arms (2)

PA-EMR (Partial ampullary endoscopic mucosal resection)

EXPERIMENTAL

Partial ampullary endoscopic mucosal resection

Procedure: PA-EMR

NKF(Needle knife fistulotomy)

ACTIVE COMPARATOR

Needle knife fistulotomy

Procedure: NKF

Interventions

PA-EMR PROCEDURE

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.

PA-EMR (Partial ampullary endoscopic mucosal resection)

NKF PROCEDURE

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.

NKF(Needle knife fistulotomy)

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duzce University: lead
• Cukurova University: collaborator

Study Sites (1)

Duzce University School of Medicine

Düzce, 81620, Turkey (Türkiye)

Location

Related Publications (4)

• Testoni PA, Mariani A, Aabakken L, Arvanitakis M, Bories E, Costamagna G, Deviere J, Dinis-Ribeiro M, Dumonceau JM, Giovannini M, Gyokeres T, Hafner M, Halttunen J, Hassan C, Lopes L, Papanikolaou IS, Tham TC, Tringali A, van Hooft J, Williams EJ. Papillary cannulation and sphincterotomy techniques at ERCP: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2016 Jul;48(7):657-83. doi: 10.1055/s-0042-108641. Epub 2016 Jun 14.

  PMID: 27299638 BACKGROUND

• Haraldsson E, Lundell L, Swahn F, Enochsson L, Lohr JM, Arnelo U; Scandinavian Association for Digestive Endoscopy (SADE) Study Group of Endoscopic Retrograde Cholangio-Pancreaticography. Endoscopic classification of the papilla of Vater. Results of an inter- and intraobserver agreement study. United European Gastroenterol J. 2017 Jun;5(4):504-510. doi: 10.1177/2050640616674837. Epub 2016 Oct 17.

  PMID: 28588881 BACKGROUND

• Katsinelos P, Lazaraki G, Chatzimavroudis G, Zavos C, Kountouras J. The endoscopic morphology of major papillae influences the selected precut technique for biliary access. Gastrointest Endosc. 2015 Apr;81(4):1056. doi: 10.1016/j.gie.2014.11.018. No abstract available.

  PMID: 25805488 BACKGROUND

• Sriram PV, Rao GV, Nageshwar Reddy D. The precut--when, where and how? A review. Endoscopy. 2003 Aug;35(8):S24-30. doi: 10.1055/s-2003-41528. No abstract available.

  PMID: 12929050 BACKGROUND

MeSH Terms

Conditions

Gallbladder Diseases; Gallstones; Pancreatic Diseases

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis; Cholecystolithiasis; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Salih Tokmak, Assist. prof

  Duzce University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asisstant Professor

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 6, 2021
• Study Start: June 1, 2021
• Primary Completion: June 21, 2022
• Study Completion: October 11, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)