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

Study Overview

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

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.

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.

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

PROCEDURE: PA-EMR
PROCEDURE: NKF

NKF vs. PA-EMR

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-09-20	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-10-11
First Submitted that Met QC Criteria 2021-09-24	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-10-12
First Posted (ACTUAL) 2021-10-06	Results First Posted N/A	Last Verified 2022-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Single

Arms and Interventions

Participant Group/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-downwa
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

Participant Group/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-downwa

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

Primary Outcome Measures	Measure Description	Time Frame
Success rate of cannulation	Successful bilary cannulation, verified by fluoroscopic images of correct guidewire positioning in the CBD, and contrast media.	1 day

Secondary Outcome Measures	Measure Description	Time Frame
Incidence rate of complications	The rate of complications (if any occur)	1 week
Cannulation time	Time from first contact with cannula to papillae to deep cannulation	1 day
Procedure time	Total procedure time	1 day

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
16 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Cukurova University

Investigators

STUDY_DIRECTOR: Salih Tokmak, Assist. prof, Duzce University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
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.
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.
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.

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