Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method

NCT ID: NCT02916199

Last Updated: 2019-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-04
• Study Completion Date: 2017-11-28

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.

Conditions

Common Bile Duct Stone; Malignant Hepatobiliary Neoplasm; Biliary Stricture; Pancreatic Diseases; Sphincter of Oddi Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Needle knife fistulotomy

Device: Needle knife fistulotomy Disease: Common bile duct stone, Malignant biliary stricture, Benign biliary stricture, Benign pancreatic disease, biliary sphincter of Oddi dysfunction Indication: High risk of post-endoscopic retrograde cholangiopancreatography pancreatitis

• Intervention: canulation of ampulla of Vater Intervention: canulation of ampulla of Vater

Group Type: EXPERIMENTAL

cannulation of ampulla of Vater

Intervention Type: DEVICE

Cannulation of ampulla of Vater is a procedure that a guide-wire is passed through ampulla using interventional devices

conventional cannulation

Device: conventional canulation catheter Disease: Common bile duct stone, Malignant biliary stricture, Benign biliary stricture, Benign pancreatic disease, biliary sphincter of Oddi dysfunction Indication: High risk of post-endoscopic retrograde cholangiopancreatography pancreatitis

• Intervention: canulation of ampulla of Vater Intervention: canulation of ampulla of Vater

Group Type: ACTIVE_COMPARATOR

cannulation of ampulla of Vater

Intervention Type: DEVICE

Cannulation of ampulla of Vater is a procedure that a guide-wire is passed through ampulla using interventional devices

Interventions

cannulation of ampulla of Vater

Cannulation of ampulla of Vater is a procedure that a guide-wire is passed through ampulla using interventional devices

Intervention Type: DEVICE

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gangnam Severance Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sung III Jang

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CHA Bundang Medical Center

Seongnam, Bundang-gu, South Korea

Gangnam Severance Hospital

Seoul, Gangnam-gu, South Korea

Dongtan Sacred Heart Hospital

Hwaseong-si, Gyeonggi-do, South Korea

In Ha University Hospital

Incheon, Jung-gu, South Korea

Soon Chun Hyang University Hospital, Cheonan

Cheonan, Namdong-gu, South Korea

Gachon University Gil Medical Center

Incheon, Namdong-gu, South Korea

Pusan National University Hospital

Busan, Seo-gu, South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 31913191 (View on PubMed)

Other Identifiers

3-2017-0092

Identifier Type: -

Identifier Source: org_study_id