CTRI

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CTRI Number

CTRI/2024/12/078772 [Registered on: 30/12/2024] Trial Registered Prospectively

Last Modified On:

27/12/2024

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

A study to compare the success rate of two different techniques of accessing the bile duct using endoscopic ultrasound when standard ERCP technique fails in patients having biliary obstruction

Scientific Title of Study

Intrahepatic versus extrahepatic approach for endoscopic ultrasound guided rendezvous technique in patients with difficult biliary 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	Associate Professor
Affiliation	Postgraduate Institute of Medical Education and Research, Chandigarh
Address	Department of Gastroenterology, PGIMER, Chandigarh Sector-12 Chandigarh CHANDIGARH 160012 India
Phone	09855319529
Fax
Email	dj_samanta@yahoo.co.in

Details of Contact Person
Scientific Query

Name	Jayanta Samanta
Designation	Associate Professor
Affiliation	Postgraduate Institute of Medical Education and Research, Chandigarh
Address	Department of Gastroenterology, PGIMER, Chandigarh Sector-12 Chandigarh CHANDIGARH 160012 India
Phone	09855319529
Fax
Email	dj_samanta@yahoo.co.in

Details of Contact Person
Public Query

Name	Jayanta Samanta
Designation	Associate Professor
Affiliation	Postgraduate Institute of Medical Education and Research, Chandigarh
Address	Department of Gastroenterology, PGIMER, Chandigarh Sector-12 Chandigarh CHANDIGARH 160012 India
Phone	09855319529
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, Block F, Level I, Department of Gastroenterology, Nehru Hospital, PGIMER 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	Department of Gastroenterology, PGIMER, Chandigarh Sector-12 Chandigarh CHANDIGARH	09855319529 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, Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

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

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Extrahepatic approach for endoscopic ultrasound guided rendezvous technique	When the standard ERCP fails, the patient who has been randomized into this arm will be taken up for the procedure. This technique will be performed using a linear array echoendoscope. First intraprocedural scanning will be done via endoscopic ultrasound (EUS) and assessment of regional vasculature will be done with color Doppler. Then, the bile duct will be punctured from D1-D2 junction in the short scope position or from the bulb in the long scope position with a 19-gauge EUS-FNA 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 maneuvered 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 ERCP therapeutic duodenoscope will be then inserted alongside the EUS-placed guidewire until the second part of the duodenum is reached. Retrograde ERCP will be attempted initially parallel to the anterogradely placed guidewire with the help of a sphincterotome or 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 to complete the procedure will be documented.
Intervention	Intrahepatic approach for endoscopic ultrasound guided rendezvous technique	When the standard ERCP fails, the patient who has been randomized into this arm will be taken up for the procedure. This technique will be performed using a linear array echoendoscope. First intraprocedural scanning will be done via endoscopic ultrasound (EUS) and assessment of regional vasculature will be done with color doppler. then, a 19 G EUS-FNA needle will be used to access the left intrahepatic bile duct in segment 2/3 from the wall of proximal gastric body. Once the needle has been advanced into the duct, bile will be aspirated to confirm the position, and the confirmation of biliary access will be done by aspiration of bile through the needle. Thereafter, contrast will be injected into the biliary tree to obtain a cholangiogram to confirm the level of obstruction. 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 maneuvered 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 remains within the distal duodenum. The ERCP therapeutic duodenoscope 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 maneuver 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 to complete 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 Distal biliary obstruction with imaging features of intrahepatic biliary radicle dilatation Patients with difficult biliary cannulation, defined as per ESGE guidelines Informed consent for the participation in study

ExclusionCriteria

Details

Patients with history of prior ERCP with papillary intervention
Pregnant patient
Hilar biliary obstruction
Patients with surgically altered anatomy
Patient hemodynamically unfit for endoscopic procedure
Uncorrectable coagulopathy or thrombocytopenia
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
Technical success of intrahepatic and extrahepatic approach for EUS-guided rendezvous technique	At baseline at the end of the index procedure

Secondary Outcome

Outcome	TimePoints
Overall complication rates Duration of the procedure Total radiation exposure during the procedure Pain score assessment using VAS score Analgesic requirement for any post procedure abdominal pain Salvage PTBD (percutaneous transhepatic biliary drainage) Hospital stay	At 2 weeks post-procedure

Target Sample Size

Total Sample Size="73"
Sample Size from India="73"
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 2/ Phase 3

Date of First Enrollment (India)

15/01/2025

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="1"
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 - Study Protocol
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 31-12-2026 and end date provided 31-12-2028?
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 used for the management of biliary obstruction due to benign or malignant biliary diseases. Guide-wire assisted cannulation technique is the primary technique recommended for biliary cannulation. Though there are advances in techniques and advanced endoscopic imaging, still 5%-20% of cases of ERCP succumb to failure in biliary cannulation (inability to achieve deep biliary cannulation). Moreover, difficult biliary cannulation has shown to increase the risk of complications, especially post ERCP pancreatitis (PEP). Various salvage techniques used to manage difficult biliary cannulation are available, wherein endoscopic ultrasound (EUS) guided rendezvous (EUS-RV) technique is a new method. EUS-RV allows access to bile duct under direct endoscopic imaging facilitating subsequent ERCP procedure. One of the advantages of EUS-RV is biliary drainage using multiple routes. The dilated intrahepatic biliary radicals (IHBR) can be accessed from the liver via the distal esophagus or stomach (Intrahepatic) or the common bile duct (CBD) can be punctured from the proximal duodenum (extrahepatic). Various retrospective studies have been published comparing the two different approaches for EUS-RV. A recent literature review on this topic reported lower technical success rate of intrahepatic approach over extrahepatic, with higher complications, procedural time and hospital stay of the former approach. With lack of randomized controlled trials (RCT) on this topic, this study (RCT) has been designed to compare the technical success of intrahepatic versus extrahepatic approach of EUS-RV at the time of index procedure. Moreover, overall complication rates, post procedure pain scoring, procedure time and radiation exposure will also be assessed in the two groups.