Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method

Pancreatic Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02916199
• Other study ID #: 3-2017-0092
• Status: Completed
• Phase: N/A
• Start date: October 4, 2016
• Est. completion date: November 28, 2017

Study information

• Verified date: January 2019
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: November 28, 2017
• Est. primary completion date: November 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Hospital	Busan-si	Seo-gu
Korea, Republic of	Soon Chun Hyang University Hospital, Cheonan	Cheonan	Namdong-gu
Korea, Republic of	Dongtan Sacred Heart Hospital	Hwaseong-si	Gyeonggi-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon	Namdong-gu
Korea, Republic of	In Ha University Hospital	Incheon	Jung-gu
Korea, Republic of	CHA Bundang Medical Center	Seongnam	Bundang-gu
Korea, Republic of	Gangnam Severance Hospital	Seoul	Gangnam-gu

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of post-endoscopic retrograde cholangiopancreatography		1 week
Secondary	Incidence rate of complications including bleeding, perforation and infection		1 week
Secondary	Success rate of cannulation		1 day
Secondary	Success rate of stone removal		1 day