ERCP SurgeryENKPTNCT07048977
Early NK Precut vs TPS in Difficult Cannulation: A RCT (ENKPT Trial)
A study testing Needle-Knife Precut Papillotomy over Pancreatic Stent and Transpancreatic Sphincterotomy in people with ERCP Surgery, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Hello. This study is about a special kind of endoscopy called ERCP, which is used to treat bile duct infections, gallstones, and blockages that cause jaundice. Normally, doctors use a standard method to insert a tube into the bile duct during the procedure. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- ERCP Surgery
- What is being tested?
- Needle-Knife Precut Papillotomy over Pancreatic Stent and Transpancreatic Sphincterotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2021to 28 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 20 years old and needed ERCP intervention for obstructive jaundice. They presented the "difficult CBD cannulation".
Who cannot join
- Patients with successful CBD cannulation within 5 minutes of standard attempts and fewer than three passages of the guidewire into the main pancreatic duct (MPD)
- Previous sphincterotomy,
- Peripapillary diverticula,
- Active pancreatitis,
- Prior gastric surgery,
- Current use of antiplatelet agents,
Show all 10Show fewer
- Coagulopathy,
- Peri-ampullary tumor-related obstruction,
- Pregnancy,
- Refused or were unable to give informed consent
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Others, 833
About this study
Official title: Comparison of Early Needle-knife Precut Papillotomy Over a Pancreatic Stent and Transpancreatic Sphincterotomy in Difficult Cannulation: A Prospective Randomized Controlled Trial
Hello. This study is about a special kind of endoscopy called ERCP, which is used to treat bile duct infections, gallstones, and blockages that cause jaundice. Normally, doctors use a standard method to insert a tube into the bile duct during the procedure. However, even skilled doctors sometimes have trouble - in about 10% to 20% of patients, it's difficult to get the tube in.
When this happens, doctors use advanced techniques called "precut" methods to help make the procedure successful. One of these is called "early needle-knife precut," which is done after trying for 5 minutes without success. Studies have shown this method can reduce the chance of getting pancreatitis (inflammation of the pancreas) afterward.
Read more
There are two common types of these advanced techniques:
Needle-knife precut over a pancreatic stent, which gently opens the area using a small cut over a temporary plastic tube.
Transpancreatic sphincterotomy, which also helps open the duct through a different approach.
Both methods can help the procedure succeed and have similar safety results. However, not many studies have compared these two methods early on in the procedure when a pancreatic stent is used.
This study wants to compare them in a safe and scientific way. If you or your family member agrees to join, the doctor will explain everything clearly. Joining is completely voluntary, and saying "no" will not affect the medical care you receive.
Read the detailed description
Purpose of the Study
This research compares two different advanced techniques used during a special endoscopy procedure (called ERCP) when it is difficult to insert a tube into the bile duct. The goal is to see which method is more successful, takes less time, and causes fewer complications:
Needle-knife precut over a pancreatic stent, and
Transpancreatic sphincterotomy (cutting through the pancreatic opening).
Who Can Join the Study?
Patients may be invited to join this study if they:
Are at least 20 years old
Are receiving their first ERCP treatment
Agree to sign a consent form
Who Cannot Join the Study?
Patients cannot join if they:
Take blood thinners or have bleeding problems
Have tumors causing narrowing in the bile duct or nearby areas
Have certain types of growths near the bile duct opening
Have abnormal intestines from previous surgery
Are currently pregnant
Have active pancreatitis (inflammation of the pancreas)
Have serious infections with symptoms like low blood pressure or difficulty breathing
How the Study Works From November 2021 to October 2023, about 400 patients will be recruited at Kaohsiung Chang Gung Memorial Hospital. If the doctor cannot insert the tube into the bile duct after 5 minutes or if the guidewire enters the pancreatic duct 3 times without success, the patient will be considered to have "difficult cannulation."
Some patients will be placed into groups based on the shape of the bile duct area.
Others will be randomly assigned to one of two groups (like flipping a coin):
Needle-knife precut over a pancreatic stent
Transpancreatic sphincterotomy followed by pancreatic stent placement
Risks and Safety
These procedures are considered safe but can have side effects. Based on past studies:
Pancreatitis (inflammation of the pancreas) may occur in about 6-10% of cases
Bleeding or perforation (a small tear in the intestine) is rare, around 0-2%
Death is very rare, less than 0.5%
Using a pancreatic stent can lower the risk of pancreatitis by about half. However, in very rare cases, the stent might move and require another procedure to remove it.
After the procedure, the patient must not eat or drink until the next day. The medical team will watch for signs of complications such as belly pain, black stool, fever, or confusion. If any of these happen, the doctor will take immediate action. If the patient feels fine the next day, they can slowly begin to eat soft or liquid food.
Joining is Voluntary Participation in the study is completely voluntary. If the patient chooses not to join, it will not affect their regular medical care in any way.
- Conditions
- ERCP Surgery
- Being tested
- Needle-Knife Precut Papillotomy over Pancreatic Stent, Transpancreatic Sphincterotomy
- Keywords
- Early Needle-knife Precut Papillotomy, Transpancreatic Sphincterotomy, Difficult Cannulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needle-Knife Precut Papillotomy over Pancreatic StentProcedure or surgery
If the papilla was treated with three unintended MPD cannulations, a needle-knife precut papillotomy with a small incision over a pancreatic stent (NKP-SIPS)
Transpancreatic SphincterotomyProcedure or surgery
TPS was performed as Goff reported; in short, after cannulation of the pancreatic duct was achieved, a pull-sphincterotome on a guidewire was used to cut the septum between the bile and pancreatic ducts along the direction from 11 o'clock to 12 o'clock. After that, the pancreatic stent is placed first, and the sphincterotomy is extended to expose the biliary lumen, and the biliary duct can be cannulated.
| Study group | Role | What they receive |
|---|---|---|
| NKP-SIPS group | Experimental | knife precut papillotomy following the pancreas stent placement Receives: Procedure: Needle-Knife Precut Papillotomy over Pancreatic Stent |
| TPS group | Active comparator | Tranpancreatic sphincterotomy followed by the pancreas stent placement Receives: Procedure: Transpancreatic Sphincterotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of common bile duct (CBD) cannulation
Successful selective biliary cannulation using the assigned intervention during the index ERCP session.
Measured: During the ERCP procedure (up to 60 minutes)
Secondary outcomes (2)
Incidence of post-ERCP pancreatitis (PEP)
Defined as new or worsened abdominal pain with serum amylase >3 times the upper limit of normal, requiring hospitalization or prolongation of hospital stay.
Measured: Within 24 hours after ERCP
Incidence of perforation
Bleeding categorized as mild (no transfusion), moderate (≤4 units transfused), or severe (≥5 units, angiography, or surgery), with a ≥2 g/dL hemoglobin drop or evidence of melena/hematemesis.
Measured: Within 72 hours after ERCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Dec 2021
- Primary completion28 Sep 2025 (estimated)
- Study completion28 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ERCP SurgeryStudies 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
- Model description
- The "difficult CBD cannulation" was defined as unsuccessful CBD cannulation after 5 minutes (stopwatch count) or three passes of the guidewire into the MPD. If the patients with three passes of the guidewire into the MPD were randomly assigned, in a 1:1 ratio, to needle knife precut papillotomy following the pancreas stent placement (NKP-SIPS group) or tranpancreatic sphincterotomy followed by the pancreas stent placement (TPS group ).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Chih-Ming, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048977
- Sponsor's protocol ID
- IRB 202101221A3
- Other IDs
- IRB 202101221A3
- Acronym
- ENKPT
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to concerns regarding patient privacy and institutional policies. In addition, the scope of this single-center study does not include external data sharing in its original ethical approval or informed consent documentation.
Publications
Pecsi D, Farkas N, Hegyi P, Balasko M, Czimmer J, Garami A, Illes A, Mosztbacher D, Par G, Parniczky A, Sarlos P, Szabo I, Szemes K, Szucs A, Vincze A. Transpancreatic sphincterotomy has a higher cannulation success rate than needle-knife precut papillotomy - a meta-analysis. Endoscopy. 2017 Sep;49(9):874-887. doi: 10.1055/s-0043-111717. Epub 2017 Jun 13.
PubMed 28609791Mariani A, Di Leo M, Giardullo N, Giussani A, Marini M, Buffoli F, Cipolletta L, Radaelli F, Ravelli P, Lombardi G, D'Onofrio V, Macchiarelli R, Iiritano E, Le Grazie M, Pantaleo G, Testoni PA. Early precut sphincterotomy for difficult biliary access to reduce post-ERCP pancreatitis: a randomized trial. Endoscopy. 2016 Jun;48(6):530-5. doi: 10.1055/s-0042-102250. Epub 2016 Mar 18.
PubMed 26990509
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Early Needle-knife Precut Papillotomy Over a Pancreatic Stent and Transpancreatic Sphincterotomy in Difficult Cannulation: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07048977
- Acronym / sponsor ID
- ENKPT / IRB 202101221A3
- Conditions
- ERCP Surgery
- Keywords
- Early Needle-knife Precut Papillotomy, Transpancreatic Sphincterotomy, Difficult Cannulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 28 Sep 2025 (estimated)
- Study completion
- 28 Oct 2025 (estimated)
- First posted
- 3 Jul 2025 (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.
Hello. This study is about a special kind of endoscopy called ERCP, which is used to treat bile duct infections, gallstones, and blockages that cause jaundice. Normally, doctors use a standard method to insert a tube into the bile duct during the procedure. However, even skilled doctors sometimes have trouble - in about 10% to 20% of patients, it's difficult to get the tube in.
When this happens, doctors use advanced techniques called "precut" methods to help make the procedure successful. One of these is called "early needle-knife precut," which is done after trying for 5 minutes without success. Studies have shown this method can reduce the chance of getting pancreatitis (inflammation of the pancreas) afterward.
There are two common types of these advanced techniques:
Needle-knife precut over a pancreatic stent, which gently opens the area using a small cut over a temporary plastic tube.
Transpancreatic sphincterotomy, which also helps open the duct through a different approach.
Both methods can help the procedure succeed and have similar safety results. However, not many studies have compared these two methods early on in the procedure when a pancreatic stent is used.
This study wants to compare them in a safe and scientific way. If you or your family member agrees to join, the doctor will explain everything clearly. Joining is completely voluntary, and saying "no" will not affect the medical care you receive.
Detailed description
Purpose of the Study
This research compares two different advanced techniques used during a special endoscopy procedure (called ERCP) when it is difficult to insert a tube into the bile duct. The goal is to see which method is more successful, takes less time, and causes fewer complications:
Needle-knife precut over a pancreatic stent, and
Transpancreatic sphincterotomy (cutting through the pancreatic opening).
Who Can Join the Study?
Patients may be invited to join this study if they:
Are at least 20 years old
Are receiving their first ERCP treatment
Agree to sign a consent form
Who Cannot Join the Study?
Patients cannot join if they:
Take blood thinners or have bleeding problems
Have tumors causing narrowing in the bile duct or nearby areas
Have certain types of growths near the bile duct opening
Have abnormal intestines from previous surgery
Are currently pregnant
Have active pancreatitis (inflammation of the pancreas)
Have serious infections with symptoms like low blood pressure or difficulty breathing
How the Study Works From November 2021 to October 2023, about 400 patients will be recruited at Kaohsiung Chang Gung Memorial Hospital. If the doctor cannot insert the tube into the bile duct after 5 minutes or if the guidewire enters the pancreatic duct 3 times without success, the patient will be considered to have "difficult cannulation."
Some patients will be placed into groups based on the shape of the bile duct area.
Others will be randomly assigned to one of two groups (like flipping a coin):
Needle-knife precut over a pancreatic stent
Transpancreatic sphincterotomy followed by pancreatic stent placement
Risks and Safety
These procedures are considered safe but can have side effects. Based on past studies:
Pancreatitis (inflammation of the pancreas) may occur in about 6-10% of cases
Bleeding or perforation (a small tear in the intestine) is rare, around 0-2%
Death is very rare, less than 0.5%
Using a pancreatic stent can lower the risk of pancreatitis by about half. However, in very rare cases, the stent might move and require another procedure to remove it.
After the procedure, the patient must not eat or drink until the next day. The medical team will watch for signs of complications such as belly pain, black stool, fever, or confusion. If any of these happen, the doctor will take immediate action. If the patient feels fine the next day, they can slowly begin to eat soft or liquid food.
Joining is Voluntary Participation in the study is completely voluntary. If the patient chooses not to join, it will not affect their regular medical care in any way.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The "difficult CBD cannulation" was defined as unsuccessful CBD cannulation after 5 minutes (stopwatch count) or three passes of the guidewire into the MPD. If the patients with three passes of the guidewire into the MPD were randomly assigned, in a 1:1 ratio, to needle knife precut papillotomy following the pancreas stent placement (NKP-SIPS group) or tranpancreatic sphincterotomy followed by the pancreas stent placement (TPS group ).
| Arm | Type | Receives |
|---|---|---|
| NKP-SIPS group | Experimental | Procedure: Needle-Knife Precut Papillotomy over Pancreatic Stentknife precut papillotomy following the pancreas stent placement |
| TPS group | Active comparator | Procedure: Transpancreatic SphincterotomyTranpancreatic sphincterotomy followed by the pancreas stent placement |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- At least 20 years old and needed ERCP intervention for obstructive jaundice. They presented the "difficult CBD cannulation".
Key exclusion criteria (10 listed)
- Patients with successful CBD cannulation within 5 minutes of standard attempts and fewer than three passages of the guidewire into the main pancreatic duct (MPD)
- Previous sphincterotomy,
- Peripapillary diverticula,
- Active pancreatitis,
- Prior gastric surgery,
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 |
|---|---|---|
| Needle-Knife Precut Papillotomy over Pancreatic StentIf the papilla was treated with three unintended MPD cannulations, a needle-knife precut papillotomy with a small incision over a pancreatic stent (NKP-SIPS) | Procedure or surgery | NKP-SIPS group |
| Transpancreatic SphincterotomyTPS was performed as Goff reported; in short, after cannulation of the pancreatic duct was achieved, a pull-sphincterotome on a guidewire was used to cut the septum between the bile and pancreatic ducts along the direction from 11 o'clock to 12 o'clock. After that, the pancreatic stent is placed first, and the sphincterotomy is extended to expose the biliary lumen, and the biliary duct can be cannulated. | Procedure or surgery | TPS group |
Primary outcome
Success rate of common bile duct (CBD) cannulation
Time frame: During the ERCP procedure (up to 60 minutes)
Successful selective biliary cannulation using the assigned intervention during the index ERCP session.
2 secondary outcomes
Incidence of post-ERCP pancreatitis (PEP)
Time frame: Within 24 hours after ERCP
Incidence of perforation
Time frame: Within 72 hours after ERCP
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Results publication: PubMed 28609791Pecsi D, Farkas N, Hegyi P, Balasko M, Czimmer J, Garami A, Illes A, Mosztbacher D, Par G, Parniczky A, Sarlos P, Szabo I, Szemes K, Szucs A, Vincze A. Transpancreatic sphincterotomy has a higher cannulation success rate than needle-knife precut papillotomy - a meta-analysis. Endoscopy. 2017 Sep;49(9):874-887. doi: 10.1055/s-0043-111717. Epub 2017 Jun 13.
- Results publication: PubMed 26990509Mariani A, Di Leo M, Giardullo N, Giussani A, Marini M, Buffoli F, Cipolletta L, Radaelli F, Ravelli P, Lombardi G, D'Onofrio V, Macchiarelli R, Iiritano E, Le Grazie M, Pantaleo G, Testoni PA. Early precut sphincterotomy for difficult biliary access to reduce post-ERCP pancreatitis: a randomized trial. Endoscopy. 2016 Jun;48(6):530-5. doi: 10.1055/s-0042-102250. Epub 2016 Mar 18.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to concerns regarding patient privacy and institutional policies. In addition, the scope of this single-center study does not include external data sharing in its original ethical approval or informed consent documentation.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Needle-Knife Precut Papillotomy over Pancreatic Stent and Transpancreatic Sphincterotomy in people with ERCP Surgery, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 3 Jul 2025. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
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 common bile duct (CBD) cannulation (time frame: During the ERCP procedure (up to 60 minutes)). 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 NCT07048977, which also lists 2 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 3 Jul 2025.