CTRI

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CTRI Number

CTRI/2026/04/109042 [Registered on: 21/04/2026] Trial Registered Prospectively

Last Modified On:

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Other (Specify) [Endoscopic ]

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Comparison of different techniques for bile duct intervention using endoscopic ultrasound and needle knife method

Scientific Title of Study

Endoscopic ultrasound guided rendezvous technique versus precut sphincterotomy as a salvage technique for difficult bile duct cannulation without inadvertent pancreatic duct cannulation: a randomized controlled trial

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Jayanta Samanta
Designation	Additional Professor
Affiliation	Postgraduate Institute of Medical Education and Research
Address	Department of Gastroenterology, PGIMER, Chandigarh, Sector 12 Chandigarh CHANDIGARH 160012 India
Phone	9855319529
Fax
Email	dj_samanta@yahoo.co.in

Details of Contact Person
Scientific Query

Name	Jayanta Samanta
Designation	Additional Professor
Affiliation	Postgraduate Institute of Medical Education and Research
Address	Department of Gastroenterology, PGIMER, Chandigarh, Sector 12 Chandigarh CHANDIGARH 160012 India
Phone	9855319529
Fax
Email	dj_samanta@yahoo.co.in

Details of Contact Person
Public Query

Name	Jayanta Samanta
Designation	Additional Professor
Affiliation	Postgraduate Institute of Medical Education and Research
Address	Department of Gastroenterology, PGIMER, Chandigarh, Sector 12 Chandigarh CHANDIGARH 160012 India
Phone	9855319529
Fax
Email	dj_samanta@yahoo.co.in

Source of Monetary or Material Support

Department of Gastroenterology, Nehru Hospital, Postgraduate Institute of Medical Education and Research, Chandigarh, Sector 12, Chandigarh, 160012

Primary Sponsor

Name	Jayanta Samanta
Address	Room 20, F Block, Level 1, Department of Gastroenterology, Nehru Hospital, Postgraduate Institute of Medical Education and Research, Chandigarh, Sector 12, Chandigarh, 160012
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Jayanta Samanta	Postgraduate Institute of Medical Education and Research, Chandigarh, India	Room no 20, Level I, Nehru Hospital, Department of Gastroenterology, PGIMER, Chandigarh - 160012 Chandigarh CHANDIGARH	9855319529 dj_samanta@yahoo.co.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Postgraduate Institute of Medical Education and Research, Chandigarh, Institute Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: K839\|\|Disease of biliary tract, unspecified, (2) ICD-10 Condition: K87\|\|Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Endoscopic ultrasound guided rendezvous technique (EUS-RV)	When standard ERCP fails, the patient randomised to this arm will be taken up for the procedure. This technique will be performed using using a linear array echoendoscope. First intraprocedural scanning will be done via EUS and assessment of regional vasculature will be done with colour doppler. Then, the bile duct will be punctured from D1-D2 junction with a 19-gauge FNA (fine needle aspiration) needle, and the confirmation of biliary access will be done by aspiration of bile through the needle. Once biliary access is confirmed, a 260-cm-long 0.025-inch hydrophilic guidewire will be inserted through the needle and directed in an anterograde manner downstream across the papilla into the duodenum. When the wire has been successfully manoeuvred down the common bile duct (CBD) to reach the duodenum, the needle will be withdrawn, followed by the echoendoscope. During withdrawal of the needle device, the standard exchange will be performed until the wire is entirely within the device. Once the needle device has been detached and entirely withdrawn from the echoendoscope, the echoendoscope will be withdrawn gradually during fluoroscopic visualization to ensure that the distal end of the wire remained within the distal duodenum. The duodenoscope (ERCP scope) will be then inserted alongside the EUS-placed guidewire until the second part of the duodenum is reached. Retrograde ERCP will be attempted parallel to the anterogradely placed guidewire with the help of a sphincterotome loaded with another guidewire. If this manoeuvre is not successful ,then the trans-papillary wire will be retrieved through the accessory channel of the duodenoscope with a snare/forceps. Once the guidewire is retrieved out of the accessory channel of the duodenoscope, a sphincterotome will be advanced over the wire for deep biliary cannulation. The time taken for the procedure will be documented.
Comparator Agent	Pre-cut sphincterotomy	When standard ERCP fails, the patient randomised to this arm will be taken up for the procedure. This procedure will be performed with a needle knife papillotome, in which a thin diathermy wire that exits the catheter will be used to incise the papilla in an upward direction beginning from the orifice. The tip of the needle knife will be placed at the orifice of the papilla or slightly cephalad to the orifice and the cut will be performed cephalad along the proximal axis of the bile duct ans assessment of the area will be made, then the guidewire can be advanced into the orifice. If the bile is seen, the needle knife cannula with a preloaded wire or a sphincterotome with a preloaded wire will be advanced and probed gently in the orifice to gain access. Once the access is secured with a guidewire, and the bile duct is confirmed with contrast, the needle knife will be exchanged over the guidewire for a standard sphincterotome and procedure will be completed. The time taken for the procedure will be documented.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	90.00 Year(s)
Gender	Both
Details	Patients with naive papilla who require therapeutic ERCP Benign biliary diseases Extrahepatic biliary obstruction All patients with difficult biliary cannulation during as per ESGE guidelines who have any one of the following more than 5 contact with papilla while attempting to cannulate or more than 5 minutes spent to cannulate following visualisation of the papilla Informed consent for participation in the study

ExclusionCriteria

Details

Previously sphincteromized papilla
malignant biliary obstruction
Hilar block
past history of post ERCP pancreatitis
inadvertant pancreatic duct cannulation or contrast injection
unstable clinical conditions precluding EUS or ERCP
pregnant patient
lack of informed consent

Method of Generating Random Sequence

Permuted block randomization, variable

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant and Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
To compare the rates of post ERCP pancreatitis between the two techniques	Within 2 weeks post procedure

Secondary Outcome

Outcome	TimePoints
Technical success overall adverse events Rate of serious adverse events Post procedure asymptomatic hyperamylasemia time taken to achieve deep biliary cannulation radiation expoure hospital stay need for second salvage procedure after failure of first salvage technique	within 2 weeks of post procedure within 2 weeks of post procedure within 3-5 days post procedure

Target Sample Size

Total Sample Size="260"
Sample Size from India="260"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 3

Date of First Enrollment (India)

30/05/2026

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="2"
Months="1"
Days="1"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - YES

What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identiﬁcation (text, tables, ﬁgures, and appendices).

What additional supporting information will be shared?
Response - None of the above
Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identiﬁed for this purpose.

For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.

By what mechanism will data be made available?
Response - Proposals should be directed to [dj_samanta@yahoo.co.in].

For how long will this data be available start date provided 31-12-2031 and end date provided 31-12-2034?
Response - Beginning 9 months and ending 36 months following article publication.

Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil

Brief Summary

Endoscopic retrograde cholangiopancreatography (ERCP) is one of the most technically challenging procedures in the field of therapeutic endoscopy and remains the standard of care for the management of extrahepatic biliary obstruction (both benign and malignant causes). The prerequisite for defining the success of this procedure is to achieve deep biliary cannulation. Though there are advances in techniques and advanced endoscopic imaging, still 5 to 20% of cases of ERCP succumb to failure in biliary cannulation. The difficult cannulation (DBC) itself carries the increased risk of post ERCP complications, mainly post ERCP pancreatitis (PEP), bleeding and perforation. Various salvage techniques used to manage DBC are needle knife pre-cut papillotomy, double wire technique, trans-pancreatic septotomy and EUS guided rendezvous technique (EUS-RV). The conventional rescue strategy for DBC is to perform a pre-cut sphincterotomy or needle knife sphincterotomy, as endorsed even by various society guidelines. Only a single randomized controlled trial (RCT) exists comparing EUS-RV versus pre-cut sphincterotomy (PcP) in benign biliary diseases with DBC by Choudhury et al showed that there is no difference in the technical success rate (92% vs. 90%; P = 1.00) between the two techniques. Five patients (10%) in the EUS-RV group and 5 patients (10%) in the precut sphincterotomy group had developed post-endoscopic retrograde cholangiopancreatography pancreatitis. Interestingly, on exploratory analysis of the sub-cohort that did not have 1 or more inadvertent PD cannulation (n=72), it was noted that 2 (5.6% [CI, 0.6% to 17.3%) patients in the precut group had PEP, whereas none of the patients in the EUS-RV had PEP (relative risk, 0.21 [CI, 0.01 to 4.25]). But this study was not powered enough to answer this question. Through the findings of this study, one can speculate, that if guidewire has not entered the pancreatic duct (PD), EUS-RV has a “zero incidence” of PEP, which makes this procedure more attractive compared to other salvage ERCP techniques. Even though sub-group analysis is not available across published literature, Dhir et al and Dalal et al also reported zero PEP rates with the EUS-RV procedure, compared to pre-cut technique (2.8% and 8.7%), respectively. Both EUS-RV and PcP are techniques wherein direct papilla orifice contact is avoided, which can theoretically reduce or nullify the risk of PEP. So, in situations wherein, after encountering a difficult bile duct cannulation, where the pancreatic duct has not been cannulated inadvertently while performing ERCP, which salvage technique would prove to be better needs to be investigated. Hence, this randomized controlled trial has been designed to answer this question.