ERCPPRIDENCT07329803
Pre-cut Versus Intentional Double Guidewire for ERCP Cannulation: Prospective, Randomized Controlled Trial
A study testing Precut Sphincterotomy and Double Guidewire Technique in people with ERCP and Choledocholithiasis, run by Asian Institute of Gastroenterology, India.
Trial summary
Endoscopic retrograde cholangiopancreatography (ERCP) is an indispensable therapeutic procedure in the management of a wide spectrum of pancreaticobiliary disorders, including choledocholithiasis, benign and malignant biliary strictures, pancreatic ductal obstructions, and postoperative bile leaks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ERCP, Choledocholithiasis, Biliary Drainage
- What is being tested?
- Precut Sphincterotomy and Double Guidewire Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- No sites listed yet
- Study dates
- 25 Jan 2026to 28 Feb 2027
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years.
- Valid indication for ERCP (benign or malignant obstruction).
- Native papilla (no prior sphincterotomy).
- Difficult Biliary Cannulation (DBC) defined by ESGE "5-5-2" criteria:
- > 5 minutes of cannulation attempts.
- > 5 contacts with the papilla.
- > 1 inadvertent pancreatic duct cannulation.
Who cannot join
- Ampullary mass or tumor preventing standard cannulation view.
- Surgically altered anatomy (e.g., Billroth II, Roux-en-Y).
- Uncorrectable coagulopathy (INR > 1.5 or Platelets < 50,000).
- Acute pancreatitis present prior to ERCP.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Endoscopic retrograde cholangiopancreatography (ERCP) is an indispensable therapeutic procedure in the management of a wide spectrum of pancreaticobiliary disorders, including choledocholithiasis, benign and malignant biliary strictures, pancreatic ductal obstructions, and postoperative bile leaks. The procedure has revolutionized the management of these conditions, often obviating the need for surgery.Precut papillotomy and Double Guidewire Technique (DGT) are both salvage techniques used in ERCP when standard biliary cannulation fails.
Precut (Needle-Knife Precut): An endoscopic incision made into the papilla to gain access to the bile duct when conventional methods fail.
Intentional Double Guidewire Technique (DGT): A technique where a guidewire is intentionally placed into the pancreatic duct to act as a "guide" or anchor, straightening the biliary axis and allowing a second guidewire to be inserted into the bile duct.
- Conditions
- ERCP, Choledocholithiasis, Biliary Drainage, Biliary Strictures Caused by Malignant Neoplasms, Biliary Stricture
- Being tested
- Precut Sphincterotomy, Double Guidewire Technique
- Keywords
- Selective CBD cannulation, Post ERCP Pancreatitis, Precut Sphincterotomy, Double Guidewire Technique
- Medical subject headings
- Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precut SphincterotomyProcedure or surgery
Precut sphincterotomy is an endoscopic rescue cannulation technique in which a needle-knife or similar cutting instrument is used to incise the papillary or periampullary tissue to facilitate access to the bile duct during ERCP.
Double Guidewire TechniqueProcedure or surgery
The double guidewire technique is an endoscopic rescue cannulation method in which a guidewire is placed into the pancreatic duct to stabilize the papilla, followed by attempted biliary cannulation alongside the pancreatic duct guidewire during ERCP.
| Study group | Role | What they receive |
|---|---|---|
| Precut Sphincterotomy Arm | Experimental | Participants undergo biliary cannulation using precut sphincterotomy as the initial rescue cannulation technique during ERCP. Receives: Procedure: Double Guidewire Technique |
| Double Guidewire Technique Arm | Active comparator | Participants undergo biliary cannulation using the double guidewire technique, with placement of a guidewire in the pancreatic duct followed by attempted biliary cannulation during ERCP. Receives: Procedure: Precut Sphincterotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safe Success
SUCCESS: Deep cannulation of the Common Bile Duct (CBD) achieved using the randomized technique within 15 minutes.
- AND ABSENCE OF Post ERCP adverse events.
Post ERCP adverse events include Post ERCP Pancreatitis, Hemorrhage, cholangitis and perforation.
Measured: 30 Days
Secondary outcomes (9)
Incidence of Post-ERCP Pancreatitis
Incidence of post-ERCP pancreatitis, defined as new or worsened abdominal pain with serum amylase or lipase ≥3 times the upper limit of normal at ≥24 hours after ERCP, requiring hospitalization or prolongation of planned admission.
Measured: 30 days
Severity of Post-ERCP Pancreatitis
Severity of post-ERCP pancreatitis classified as mild, moderate, or severe according to the revised Atlanta classification.
Measured: 30 days
Overall ERCP-Related Adverse Events
Incidence of ERCP-related adverse events, including bleeding, perforation, cholangitis, and post-ERCP pancreatitis, graded according to the ASGE lexicon.
Measured: 30 days
Cannulation Time
Time required to achieve deep biliary cannulation, measured from insertion of the duodenoscope into the second part of the duodenum to successful deep bile duct cannulation.
Measured: During the ERCP procedure
Total Procedure Time
Total ERCP procedure duration, measured from duodenoscope insertion to scope withdrawal.
Measured: During the ERCP procedure
Need for Rescue Cannulation Technique
Proportion of patients requiring crossover to an alternative rescue cannulation technique after failure of the initially assigned technique.
Measured: During the ERCP procedure
Hyperamylasemia Without Clinical Pancreatitis
Incidence of asymptomatic hyperamylasemia, defined as serum amylase or lipase ≥3 times the upper limit of normal without clinical features of pancreatitis.
Measured: At 24 hours after ERCP
Hospital Length of Stay
Duration of hospital stay measured in days from ERCP to hospital discharge
Measured: Up to 30 days after ERCP
30-Day All-Cause Readmission
Rate of hospital readmission for any cause after ERCP.
Measured: Up to 30 days after ERCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start25 Jan 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ERCPStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 840 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
- Investigators
- DR SHUJAATH ASIF, MD,DM, Principal investigator, Asian Institute Of Gastroenterology Private Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329803
- Sponsor's protocol ID
- PRIDE
- Acronym
- PRIDE
- Status last verified
- Jan 2026
- First submitted
- 26 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-cut Versus Intentional Double Guidewire for ERCP Cannulation: Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07329803
- Acronym / sponsor ID
- PRIDE / PRIDE
- Conditions
- ERCP, Choledocholithiasis, Biliary Drainage, Biliary Strictures Caused by Malignant Neoplasms, Biliary Stricture
- Keywords
- Selective CBD cannulation, Post ERCP Pancreatitis, Precut Sphincterotomy, Double Guidewire Technique
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 840 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 25 Jan 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 9 Jan 2026 (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.
Endoscopic retrograde cholangiopancreatography (ERCP) is an indispensable therapeutic procedure in the management of a wide spectrum of pancreaticobiliary disorders, including choledocholithiasis, benign and malignant biliary strictures, pancreatic ductal obstructions, and postoperative bile leaks. The procedure has revolutionized the management of these conditions, often obviating the need for surgery.Precut papillotomy and Double Guidewire Technique (DGT) are both salvage techniques used in ERCP when standard biliary cannulation fails.
Precut (Needle-Knife Precut): An endoscopic incision made into the papilla to gain access to the bile duct when conventional methods fail.
Intentional Double Guidewire Technique (DGT): A technique where a guidewire is intentionally placed into the pancreatic duct to act as a "guide" or anchor, straightening the biliary axis and allowing a second guidewire to be inserted into the bile duct.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Precut Sphincterotomy Arm | Experimental | Procedure: Double Guidewire TechniqueParticipants undergo biliary cannulation using precut sphincterotomy as the initial rescue cannulation technique during ERCP. |
| Double Guidewire Technique Arm | Active comparator | Procedure: Precut SphincterotomyParticipants undergo biliary cannulation using the double guidewire technique, with placement of a guidewire in the pancreatic duct followed by attempted biliary cannulation during ERCP. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18 years.
- Valid indication for ERCP (benign or malignant obstruction).
- Native papilla (no prior sphincterotomy).
- Difficult Biliary Cannulation (DBC) defined by ESGE "5-5-2" criteria:
- > 5 minutes of cannulation attempts.
Key exclusion criteria (4 listed)
- Ampullary mass or tumor preventing standard cannulation view.
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 |
|---|---|---|
| Precut SphincterotomyPrecut sphincterotomy is an endoscopic rescue cannulation technique in which a needle-knife or similar cutting instrument is used to incise the papillary or periampullary tissue to facilitate access to the bile duct during ERCP. | Procedure or surgery | Double Guidewire Technique Arm |
| Double Guidewire TechniqueThe double guidewire technique is an endoscopic rescue cannulation method in which a guidewire is placed into the pancreatic duct to stabilize the papilla, followed by attempted biliary cannulation alongside the pancreatic duct guidewire during ERCP. | Procedure or surgery | Precut Sphincterotomy Arm |
Primary outcome
Safe Success
Time frame: 30 Days
SUCCESS: Deep cannulation of the Common Bile Duct (CBD) achieved using the randomized technique within 15 minutes. * AND ABSENCE OF Post ERCP adverse events. Post ERCP adverse events include Post ERCP Pancreatitis, Hemorrhage, cholangitis and perforation.
9 secondary outcomes
Incidence of Post-ERCP Pancreatitis
Time frame: 30 days
Severity of Post-ERCP Pancreatitis
Time frame: 30 days
Overall ERCP-Related Adverse Events
Time frame: 30 days
Cannulation Time
Time frame: During the ERCP procedure
Total Procedure Time
Time frame: During the ERCP procedure
Need for Rescue Cannulation Technique
Time frame: During the ERCP procedure
Hyperamylasemia Without Clinical Pancreatitis
Time frame: At 24 hours after ERCP
Hospital Length of Stay
Time frame: Up to 30 days after ERCP
30-Day All-Cause Readmission
Time frame: Up to 30 days 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 12 Jan 2026.
- 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.
DR SHUJAATH ASIF, MD,DM principal investigator
Asian Institute Of Gastroenterology Private Limited
Questions about this trial
What is this clinical trial studying?
A study testing Precut Sphincterotomy and Double Guidewire Technique in people with ERCP and Choledocholithiasis, run by Asian Institute of Gastroenterology, India.
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 7 inclusion and 4 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: opening soon, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact DR SHUJAATH ASIF, MD,DM (9600037286, Asif.shujaath@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safe Success (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2026.