Clinical trial NCT02916199: Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method
Official title: Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method in Patients With High Risk of Post-endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Common Bile Duct Stone
Malignant Hepatobiliary Neoplasm
Biliary Stricture
Pancreatic Diseases
Sphincter of Oddi Dysfunction
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 207
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study are to evaluate the feasibility of needle knife fistulotomy (NKF) as an initial procedure for biliary access in patients with biliary disease who are at increased risk for post-endoscopic retrograde endoscopic retrograde cholangiopancreatography (PEP) and to assess the incidence rate of complications including PEP between NKF and conventional cannulation methods.

Detailed description: Endoscopic retrograde endoscopic retrograde cholangiopancreatography (ERCP) is widely used for the diagnosis and treatment of pancreatic and biliary tract disease. However, post-ERCP pancreatitis (PEP) is the most common adverse event following the procedure, ranging from 2% to 10% in nonselective cases, and it can cause substantial morbidity, mortality, or high medical costs. Recent advances in cannulation technique and accessories for biliary cannulation have contributed to reduce the incidence of PEP, but biliary cannulation can fail in 5% to 20% of cases of ERCP. Suprapapillary needle-knife fistulotomy (NKF), with or without large-diameter balloon dilation, has been used as a rescue method in cases of difficult biliary cannulation, and NKF was recommended as an initial approach to selective biliary cannulation in cases of repetitive unintentional pancreatic cannulation.9 Moreover, difficult biliary cannulation is known to be a risk factor for PEP, and it has been reported that NKF is associated with a low risk of PEP. Thus, we hypothesized that NKF may reduce the risk of PEP in patients who are at increased risk for PEP.

Eligibility criteria: Inclusion Criteria:

* Patient who submitted a written informed consent for the this trial, and 18 \~ 90 years old
* Patient who have naïve ampulla (no previous procedure was performed at ampulla)
* Patient who is suspected to have 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 pancreatitis among bellows (at least one more);

  1. suspected biliary sphincter of Oddi dysfunction
  2. young age (18\~50 years)
  3. female
  4. normal common bile duct diameter (≤9mm)
  5. normal serum bilirubin level
  6. Obesity (body mass index \> 30)
  7. Past history of acute pancreatitis

Exclusion Criteria:

* Patient who is below 18 year old
* Patient who is pregnant
* Patient with mental retardation
* Patient is sensitive to contrast agents
* Patient who received sphincterotomy or pancreatobiliary operation previously
* Patient who have ampulla of Vater cancer
* Patient who have difficulty for 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);

  1. Patient who have acute pancreatitis within 30days before enrollment
  2. Patient who have idiopathic acute recurrent pancreatitis
  3. Patient who have pancreatic divisum
  4. Patient who have obstructive chronic pancreatitis
  5. Patient who pancreatic cancer
* Patients who have improper ampulla shape as bellows;

  1. Small ampulla (ampulla without oral protrusion)
  2. Flat or crooked or asymmetric ampulla
  3. Ampulla with peri-ampullary diverticulum type I or II

Primary outcomes:
measure: Incidence rate of post-endoscopic retrograde cholangiopancreatography
timeFrame: 1 week
Secondary outcomes:
measure: Incidence rate of complications including bleeding, perforation and infection
timeFrame: 1 week
measure: Success rate of cannulation
timeFrame: 1 day
measure: Success rate of stone removal
timeFrame: 1 day
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center
state: Bundang-gu
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
state: Gangnam-gu
city: Hwaseong-si
country: Korea, Republic of
facility: Dongtan Sacred Heart Hospital
state: Gyeonggi-do
city: Incheon
country: Korea, Republic of
facility: In Ha University Hospital
state: Jung-gu
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital, Cheonan
state: Namdong-gu
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Namdong-gu
city: Busan-si
country: Korea, Republic of
facility: Pusan National University Hospital
state: Seo-gu
Study officials:
References:
citation: Jang SI, Kim DU, Cho JH, Jeong S, Park JS, Lee DH, Kwon CI, Koh DH, Park SW, Lee TH, Lee HS. Primary Needle-Knife Fistulotomy Versus Conventional Cannulation Method in a High-Risk Cohort of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis. Am J Gastroenterol. 2020 Apr;115(4):616-624. doi: 10.14309/ajg.0000000000000480.