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Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method

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ClinicalTrials.gov Identifier: NCT02916199
Recruitment Status : Completed
First Posted : September 27, 2016
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Sung III Jang, Gangnam Severance Hospital

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.

Condition or disease Intervention/treatment Phase
Common Bile Duct Stone Malignant Hepatobiliary Neoplasm Biliary Stricture Pancreatic Diseases Sphincter of Oddi Dysfunction Device: cannulation of ampulla of Vater Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : October 4, 2016
Actual Primary Completion Date : November 28, 2017
Actual Study Completion Date : November 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: 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

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

Active Comparator: 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

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




Primary Outcome Measures :
  1. Incidence rate of post-endoscopic retrograde cholangiopancreatography [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. Incidence rate of complications including bleeding, perforation and infection [ Time Frame: 1 week ]
  2. Success rate of cannulation [ Time Frame: 1 day ]
  3. Success rate of stone removal [ Time Frame: 1 day ]


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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02916199


Locations
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Korea, Republic of
CHA Bundang Medical Center
Seongnam, Bundang-gu, Korea, Republic of, 13496
Gangnam Severance Hospital
Seoul, Gangnam-gu, Korea, Republic of, 06229
Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, Korea, Republic of, 18450
In Ha University Hospital
Incheon, Jung-gu, Korea, Republic of, 22332
Soon Chun Hyang University Hospital, Cheonan
Cheonan, Namdong-gu, Korea, Republic of, 31151
Gachon University Gil Medical Center
Incheon, Namdong-gu, Korea, Republic of, 21565
Pusan National University Hospital
Busan-si, Seo-gu, Korea, Republic of, 49241
Sponsors and Collaborators
Gangnam Severance Hospital

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Responsible Party: Sung III Jang, Assistant professor, Gangnam Severance Hospital
ClinicalTrials.gov Identifier: NCT02916199     History of Changes
Other Study ID Numbers: 3-2017-0092
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Pancreatic Diseases
Sphincter of Oddi Dysfunction
Digestive System Diseases
Biliary Dyskinesia
Common Bile Duct Diseases
Bile Duct Diseases
Biliary Tract Diseases