Common Bile Duct StoneNCT02916199
Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method
A study testing cannulation of ampulla of Vater in people with Common Bile Duct Stone and Malignant Hepatobiliary Neoplasm, run by Gangnam Severance Hospital at 7 sites in South Korea.
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… Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Common Bile Duct Stone, Malignant Hepatobiliary Neoplasm, Biliary Stricture
- What is being tested?
- cannulation of ampulla of Vater
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 4 Oct 2016to 28 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
- suspected biliary sphincter of Oddi dysfunction
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- young age (18~50 years)
- female
- normal common bile duct diameter (≤9mm)
- normal serum bilirubin level
- Obesity (body mass index > 30)
- Past history of acute pancreatitis
Who cannot join
- 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
Show all 17Show fewer
- 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);
- Patient who have acute pancreatitis within 30days before enrollment
- Patient who have idiopathic acute recurrent pancreatitis
- Patient who have pancreatic divisum
- Patient who have obstructive chronic pancreatitis
- Patient who pancreatic cancer
- Patients who have improper ampulla shape as bellows;
- Small ampulla (ampulla without oral protrusion)
- Flat or crooked or asymmetric ampulla
- Ampulla with peri-ampullary diverticulum type I or II
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Pusan National University Hospital
Busan, Seo-gu, 49241
Soon Chun Hyang University Hospital, Cheonan
Cheonan, Namdong-gu, 31151
Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, 18450
In Ha University Hospital
Incheon, Jung-gu, 22332
Gachon University Gil Medical Center
Incheon, Namdong-gu, 21565
CHA Bundang Medical Center
Seongnam, Bundang-gu, 13496
Gangnam Severance Hospital
Seoul, Gangnam-gu, 06229
About this study
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
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.
Read the 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
- Being tested
- cannulation of ampulla of Vater
- Medical subject headings
- Gallstones, Pancreatic Diseases, Sphincter of Oddi Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cannulation of ampulla of VaterDevice
Cannulation of ampulla of Vater is a procedure that a guide-wire is passed through ampulla using interventional devices
| Study group | Role | What they receive |
|---|---|---|
| Needle knife fistulotomy | Experimental | 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 Receives: Device: cannulation of ampulla of Vater |
| conventional cannulation | Active comparator | 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 Receives: Device: cannulation of ampulla of Vater |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of post-endoscopic retrograde cholangiopancreatography
Measured: 1 week
Secondary outcomes (3)
Incidence rate of complications including bleeding, perforation and infection
Measured: 1 week
Success rate of cannulation
Measured: 1 day
Success rate of stone removal
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study start4 Oct 2016
- Primary completion28 Nov 2017
- Study completion28 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Common Bile Duct StoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung III Jang, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916199
- Sponsor's protocol ID
- 3-2017-0092
- Status last verified
- Jan 2019
- First submitted
- 24 Sep 2016
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31913191
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02916199
- Acronym / sponsor ID
- 3-2017-0092
- Conditions
- Common Bile Duct Stone, Malignant Hepatobiliary Neoplasm, Biliary Stricture, Pancreatic Diseases, Sphincter of Oddi Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 4 Oct 2016 (actual)
- Primary completion
- 28 Nov 2017 (actual)
- Study completion
- 28 Nov 2017 (actual)
- First posted
- 27 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Needle knife fistulotomy | Experimental | Device: cannulation of ampulla of VaterDevice: 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 |
| conventional cannulation | Active comparator | Device: cannulation of ampulla of VaterDevice: 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 |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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);
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cannulation of ampulla of VaterCannulation of ampulla of Vater is a procedure that a guide-wire is passed through ampulla using interventional devices | Device | Needle knife fistulotomy, conventional cannulation |
Primary outcome
Incidence rate of post-endoscopic retrograde cholangiopancreatography
Time frame: 1 week
3 secondary outcomes
Incidence rate of complications including bleeding, perforation and infection
Time frame: 1 week
Success rate of cannulation
Time frame: 1 day
Success rate of stone removal
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Derived from this study: PubMed 31913191Jang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cannulation of ampulla of Vater in people with Common Bile Duct Stone and Malignant Hepatobiliary Neoplasm, run by Gangnam Severance Hospital at 7 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of post-endoscopic retrograde cholangiopancreatography (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02916199, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.