Biliary DiseaseNCT05068739
Needle Knife Fistulotomy Versus Partial Ampullary Endoscopic Mucosal Resection for Difficult Biliary Cannulation
A study testing PA-EMR and NKF in people with Biliary Disease and Common Bile Duct Calculi, run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
The aims of this study are to compare the needle knife fistulotomy (NKF) technique versus the partial ampullary endoscopic mucosal resection (PA-EMR) technique in patients with difficult biliary cannulation and to assess the incidence rate of complications between these cannulation methods. Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Biliary Disease, Common Bile Duct Calculi, Biliary Stricture
- What is being tested?
- PA-EMR and NKF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 11 Oct 2022
- 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 16 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient who submitted a written informed consent for this trial, and aged between 18-90 years old
- Patient who have naïve papilla (no previous procedure was performed at ampulla)
- Patient who is suspected to have a 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 p
Who cannot join
- Patient who is pregnant
- Patient with mental retardation
- Patient allergic to contrast agents
- Patient who received sphincterotomy or pancreatobiliary operation previously
- Patient who have ampulla of Vater cancer
- Patient who have difficulty for the approach to ampulla due to abdominal surgery including stomach cancer with Billroth II anastomosis
Show all 13Show fewer
- Patient who have pancreatic diseases as bellow (at least one more);
- acute pancreatitis within 30days before enrollment
- idiopathic acute recurrent pancreatitis
- pancreas divisum
- obstructive chronic pancreatitis
- pancreatic cancer
- Patients with Type-1, non-protruding Type-2 and Type-4 papilla
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Duzce University School of Medicine
Düzce, 81620
About this study
The aims of this study are to compare the needle knife fistulotomy (NKF) technique versus the partial ampullary endoscopic mucosal resection (PA-EMR) technique in patients with difficult biliary cannulation and to assess the incidence rate of complications between these cannulation methods.
Read the detailed description
Cannulation success with standard techniques reported to be around 95% even in expert hands and despite all efforts, it can be challenging that needs an alternate intervention.
NKF is recommended as the initial technique for pre-cutting because the rate of post-ERCP pancreatitis (PEP) is significantly low but there is an ongoing debate about limiting its use in certain types of papillae with a long intra-mural segment
Indeed the shape of the papillae influences the success of bile duct cannulation and the choice of the pre-cutting technique. Type-2 and Type-3 papillae are more difficult to cannulate than Type-1. NKF can be performed as the initial technique for pre-cutting in protruded Type-2 and Type-3 papillae but it has some limitations.
First of all, the incision can be erratic because it is performed without a guidewire and uncontrolled. This can cause a tattered mucosa as the incision progress and the papillae lose anatomic contours. Some amount of bleeding may also unavoidably occur and the field of view further impaired. If the initial incision line is incorrect and additional incision is needed, more crumpled and deformed papillae with irregular margins may be encountered. These undesired results are frequently experienced and prevent a clean-cut, thus further complicate the cannulation. Even perforation can occur.
Recently the investigators described a novel technique, PA-EMR, for difficult biliary cannulation in patients with protruded Type-2, Type-3, and shar-pei papilla. The investigators hypothesized that with this new technique cannulation success will be higher, procedure time will be shorter and the adverse events will be lower versus NKF technique.
- Conditions
- Biliary Disease, Common Bile Duct Calculi, Biliary Stricture, Malignant Hepatobiliary Neoplasm, Pancreatic Disease
- Being tested
- PA-EMR, NKF
- Keywords
- ERCP, cannulation, endoscopic sphincterotomy
- Medical subject headings
- Gallbladder Diseases, Gallstones, Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA-EMRProcedure or surgery
Standard oval-shaped, braided wire polypectomy snare with 10 mm or 20 mm loop diameter will be used. With the duodenoscope in a semi-long position, the tip of the snare will be anchored just below the transverse fold of the ampulla and opened above-downwards fashion until the orifice will be seen. The orifice will be strictly preserved to avoid the risk of PEP and approximately the upper two-thirds of the ampullary mound will be grabbed by the snare. The direction and the depth will be controlled by combined movements of the elevator and wheels of the duodenoscope. After removal of the mucosa, the wall of choledochus will be seen clearly and standard wire-guided cannulation (WGC) will be performed. If cannulation can not be achieved with WGC, an additional incision will be performed to the wall of the choledochus with a needle knife.
NKFProcedure or surgery
The needle knife will be placed at the junction of the upper one-third and lower two-thirds of the papillary roof (bulging portion). Minimal, superficial incisions will be made in the 11-12 o'clock direction. The length of the fistulotomy will be at the endoscopist's discretion, depending on the shape of the papilla. The cut will be extended until bile juice, the pinkish bile duct mucosa, and/or the bulging of the white sphincter of the Oddi's muscle is visible.
| Study group | Role | What they receive |
|---|---|---|
| PA-EMR (Partial ampullary endoscopic mucosal resection) | Experimental | Partial ampullary endoscopic mucosal resection Receives: Procedure: PA-EMR |
| NKF(Needle knife fistulotomy) | Active comparator | Needle knife fistulotomy Receives: Procedure: NKF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of cannulation
Successful bilary cannulation, verified by fluoroscopic images of correct guidewire positioning in the CBD, and contrast media.
Measured: 1 day
Secondary outcomes (3)
Incidence rate of complications
The rate of complications (if any occur)
Measured: 1 week
Cannulation time
Time from first contact with cannula to papillae to deep cannulation
Measured: 1 day
Procedure time
Total procedure time
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 posted6 Oct 2021
- Study start1 Jun 2021
- Primary completion21 Jun 2022
- Study completion11 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Biliary DiseaseStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Collaborators
- Cukurova University
- Responsible party
- Principal investigator, Salih Tokmak, Duzce University
- Investigators
- Salih Tokmak, Assist. prof, Study director, Duzce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068739
- Sponsor's protocol ID
- NKF vs. PA-EMR
- Status last verified
- Oct 2022
- First submitted
- 20 Sep 2021
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Testoni PA, Mariani A, Aabakken L, Arvanitakis M, Bories E, Costamagna G, Deviere J, Dinis-Ribeiro M, Dumonceau JM, Giovannini M, Gyokeres T, Hafner M, Halttunen J, Hassan C, Lopes L, Papanikolaou IS, Tham TC, Tringali A, van Hooft J, Williams EJ. Papillary cannulation and sphincterotomy techniques at ERCP: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2016 Jul;48(7):657-83. doi: 10.1055/s-0042-108641. Epub 2016 Jun 14.
PubMed 27299638Haraldsson E, Lundell L, Swahn F, Enochsson L, Lohr JM, Arnelo U; Scandinavian Association for Digestive Endoscopy (SADE) Study Group of Endoscopic Retrograde Cholangio-Pancreaticography. Endoscopic classification of the papilla of Vater. Results of an inter- and intraobserver agreement study. United European Gastroenterol J. 2017 Jun;5(4):504-510. doi: 10.1177/2050640616674837. Epub 2016 Oct 17.
PubMed 28588881Katsinelos P, Lazaraki G, Chatzimavroudis G, Zavos C, Kountouras J. The endoscopic morphology of major papillae influences the selected precut technique for biliary access. Gastrointest Endosc. 2015 Apr;81(4):1056. doi: 10.1016/j.gie.2014.11.018. No abstract available.
PubMed 25805488Sriram PV, Rao GV, Nageshwar Reddy D. The precut--when, where and how? A review. Endoscopy. 2003 Aug;35(8):S24-30. doi: 10.1055/s-2003-41528. No abstract available.
PubMed 12929050
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Needle Knife Fistulotomy Versus Partial Ampullary Endoscopic Mucosal Resection for Difficult Biliary Cannulation
- ClinicalTrials.gov ID
- NCT05068739
- Acronym / sponsor ID
- NKF vs. PA-EMR
- Conditions
- Biliary Disease, Common Bile Duct Calculi, Biliary Stricture, Malignant Hepatobiliary Neoplasm, Pancreatic Disease
- Keywords
- ERCP, cannulation, endoscopic sphincterotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Collaborators
- Cukurova University
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 11 Oct 2022 (actual)
- First posted
- 6 Oct 2021 (actual)
- 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 aims of this study are to compare the needle knife fistulotomy (NKF) technique versus the partial ampullary endoscopic mucosal resection (PA-EMR) technique in patients with difficult biliary cannulation and to assess the incidence rate of complications between these cannulation methods.
Detailed description
Cannulation success with standard techniques reported to be around 95% even in expert hands and despite all efforts, it can be challenging that needs an alternate intervention.
NKF is recommended as the initial technique for pre-cutting because the rate of post-ERCP pancreatitis (PEP) is significantly low but there is an ongoing debate about limiting its use in certain types of papillae with a long intra-mural segment
Indeed the shape of the papillae influences the success of bile duct cannulation and the choice of the pre-cutting technique. Type-2 and Type-3 papillae are more difficult to cannulate than Type-1. NKF can be performed as the initial technique for pre-cutting in protruded Type-2 and Type-3 papillae but it has some limitations.
First of all, the incision can be erratic because it is performed without a guidewire and uncontrolled. This can cause a tattered mucosa as the incision progress and the papillae lose anatomic contours. Some amount of bleeding may also unavoidably occur and the field of view further impaired. If the initial incision line is incorrect and additional incision is needed, more crumpled and deformed papillae with irregular margins may be encountered. These undesired results are frequently experienced and prevent a clean-cut, thus further complicate the cannulation. Even perforation can occur.
Recently the investigators described a novel technique, PA-EMR, for difficult biliary cannulation in patients with protruded Type-2, Type-3, and shar-pei papilla. The investigators hypothesized that with this new technique cannulation success will be higher, procedure time will be shorter and the adverse events will be lower versus NKF technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PA-EMR (Partial ampullary endoscopic mucosal resection) | Experimental | Procedure: PA-EMRPartial ampullary endoscopic mucosal resection |
| NKF(Needle knife fistulotomy) | Active comparator | Procedure: NKFNeedle knife fistulotomy |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patient who submitted a written informed consent for this trial, and aged between 18-90 years old
- Patient who have naïve papilla (no previous procedure was performed at ampulla)
- Patient who is suspected to have a 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 p
Key exclusion criteria (13 listed)
- Patient who is pregnant
- Patient with mental retardation
- Patient allergic to contrast agents
- Patient who received sphincterotomy or pancreatobiliary operation previously
- Patient who have ampulla of Vater cancer
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 |
|---|---|---|
| PA-EMRStandard oval-shaped, braided wire polypectomy snare with 10 mm or 20 mm loop diameter will be used. With the duodenoscope in a semi-long position, the tip of the snare will be anchored just below the transverse fold of the ampulla and opened above-downwards fashion until the orifice will be seen. The orifice will be strictly preserved to avoid the risk of PEP and approximately the upper two-thirds of the ampullary mound will be grabbed by the snare. The direction and the depth will be controlled by combined movements of the elevator and wheels of the duodenoscope. After removal of the mucosa, the wall of choledochus will be seen clearly and standard wire-guided cannulation (WGC) will be performed. If cannulation can not be achieved with WGC, an additional incision will be performed to the wall of the choledochus with a needle knife. | Procedure or surgery | PA-EMR (Partial ampullary endoscopic mucosal resection) |
| NKFThe needle knife will be placed at the junction of the upper one-third and lower two-thirds of the papillary roof (bulging portion). Minimal, superficial incisions will be made in the 11-12 o'clock direction. The length of the fistulotomy will be at the endoscopist's discretion, depending on the shape of the papilla. The cut will be extended until bile juice, the pinkish bile duct mucosa, and/or the bulging of the white sphincter of the Oddi's muscle is visible. | Procedure or surgery | NKF(Needle knife fistulotomy) |
Primary outcome
Success rate of cannulation
Time frame: 1 day
Successful bilary cannulation, verified by fluoroscopic images of correct guidewire positioning in the CBD, and contrast media.
3 secondary outcomes
Incidence rate of complications
Time frame: 1 week
Cannulation time
Time frame: 1 day
Procedure time
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 12 Oct 2022.
- Background: PubMed 27299638Testoni PA, Mariani A, Aabakken L, Arvanitakis M, Bories E, Costamagna G, Deviere J, Dinis-Ribeiro M, Dumonceau JM, Giovannini M, Gyokeres T, Hafner M, Halttunen J, Hassan C, Lopes L, Papanikolaou IS, Tham TC, Tringali A, van Hooft J, Williams EJ. Papillary cannulation and sphincterotomy techniques at ERCP: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2016 Jul;48(7):657-83. doi: 10.1055/s-0042-108641. Epub 2016 Jun 14.
- Background: PubMed 28588881Haraldsson E, Lundell L, Swahn F, Enochsson L, Lohr JM, Arnelo U; Scandinavian Association for Digestive Endoscopy (SADE) Study Group of Endoscopic Retrograde Cholangio-Pancreaticography. Endoscopic classification of the papilla of Vater. Results of an inter- and intraobserver agreement study. United European Gastroenterol J. 2017 Jun;5(4):504-510. doi: 10.1177/2050640616674837. Epub 2016 Oct 17.
- Background: PubMed 25805488Katsinelos P, Lazaraki G, Chatzimavroudis G, Zavos C, Kountouras J. The endoscopic morphology of major papillae influences the selected precut technique for biliary access. Gastrointest Endosc. 2015 Apr;81(4):1056. doi: 10.1016/j.gie.2014.11.018. No abstract available.
- Background: PubMed 12929050Sriram PV, Rao GV, Nageshwar Reddy D. The precut--when, where and how? A review. Endoscopy. 2003 Aug;35(8):S24-30. doi: 10.1055/s-2003-41528. No abstract available.
- 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.
Salih Tokmak, Assist. prof study director
Duzce University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PA-EMR and NKF in people with Biliary Disease and Common Bile Duct Calculi, run by Duzce University at 1 site in Turkey (Türkiye).
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 5 inclusion and 13 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 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Success rate of cannulation (time frame: 1 day). 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 NCT05068739, which also lists 4 linked publications.
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 12 Oct 2022.