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CTRI Number  CTRI/2025/12/099651 [Registered on: 22/12/2025] Trial Registered Prospectively
Last Modified On: 19/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Single versus Double Plastic Stents for Bile Duct Drainage During ERCP: A Clinical Study 
Scientific Title of Study   Prospective Comparative Study of Single vs Double Plastic Stents for Biliary Drainage in Patients of Malignant Distal CBD Obstruction Undergoing ERCP 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hemanta Kumar Nayak 
Designation  Assosciate Professor 
Affiliation  AIIMS, Bhubaneswar 
Address  Room no - 222, Department of Gastroenterology, AIIMS, Bhubaneswar, Patrapda, Sijua, Pin- 751019

Khordha
ORISSA
751019
India 
Phone  7008927243  
Fax    
Email  drhemantnayak@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Hemanta Kumar Nayak 
Designation  Assosciate Professor 
Affiliation  AIIMS, Bhubaneswar 
Address  Room no - 222, Department of Gastroenterology, AIIMS, Bhubaneswar, Patrapda, Sijua, Pin- 751019

Khordha
ORISSA
751019
India 
Phone  7008927243  
Fax    
Email  drhemantnayak@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Hemanta Kumar Nayak 
Designation  Assosciate Professor 
Affiliation  AIIMS, Bhubaneswar 
Address  Room no - 222, Department of Gastroenterology, AIIMS, Bhubaneswar, Patrapda, Sijua, Pin- 751019

Khordha
ORISSA
751019
India 
Phone  7008927243  
Fax    
Email  drhemantnayak@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Hemanta Kumar Nayak 
Address  Room No-222, Department of Gastroenterology, AIIMS, Bhubaneswar, Sijua, Patrapada, 751019 
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 Hemanta Kumar Nayak  All India Institute of Medical Sciences, Bhubaneswar  Room no - 222, Department of Gastroenterology, AIIMS, Bhubaneswar, Patrapda, Sijua, Pin- 751019
Khordha
ORISSA 
7008927243

drhemantnayak@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS, Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K831||Obstruction of bile duct,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Plastic stent  Arm A (Double DPT): ERCP with placement of two DPT stents (both 7Fr or 10Fr, as per anatomy)  
Comparator Agent  Plastic stent  Arm B (Single DPT) ERCP with placement of a single 7Fr or 10Fr double-pigtail plastic stent  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Age 18 to 80 years.
2.Indicated for biliary drainage by ERCP (malignant obstruction.
3.CBD diameter greater than 8 mm.
4.Distal CBD or mid-distal CBD block.
5.Written informed consent.
 
 
ExclusionCriteria 
Details  1.Previous biliary stenting.
2.Coagulopathy (INR greater than 1.5 or platelets less than 50,000).
3.Severe comorbidities (e.g., advanced cardiac or renal disease).
4.Pregnancy.
5.Altered anatomy preventing standard ERCP.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The Resolution of cholestasis that is greater than equal to 50% reduction in bilirubin at 7 days or normalization within 4 weeks and improvement in symptoms.  At Day 7 and Day 28 
 
Secondary Outcome  
Outcome  TimePoints 
1.Stent dysfunction rate at 3 months
2.Need for re-intervention
3.Procedure-related complications (bleeding, perforation, pancreatitis, infection)
4.Stent migration or occlusion
5.Patency duration (time to dysfunction)
 
At 3 months and 6 months 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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/ Phase 4 
Date of First Enrollment (India)   15/01/2026 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  

Endoscopic retrograde cholangiopancreatography (ERCP) is the gold-standard therapeutic procedure for managing biliary obstruction of both benign and malignant etiology. Biliary drainage via stent placement is essential in cases of cholestasis, cholangitis, or obstructive jaundice. Plastic stents (including straight and pigtail designs) and self-expandable metal stents (SEMS) are the two main types used.Plastic stents are commonly used due to their ease of insertion, cost-effectiveness, and suitability for temporary drainage especially in benign strictures, peri-procedural biliary decompression, or patients awaiting surgery. The double-pigtail plastic stent (DPT) has become the preferred choice due to its ability to minimize migration, anchor securely across strictures, and reduce perforation risk .

In malignant biliary strictures, studies suggest multiple stents (especially SEMS) can offer better patency and less dysfunction than a single stent.

Some advantages Hypothesized for Double DPT Stents are

·         Enhanced biliary drainage due to increased stent lumen availability.

·         Lower risk of stent occlusion or early dysfunction.

·         Reduced need for early re-intervention.

·         Better anchorage in dilated CBDs, reducing risk of migration.

However, some concerns with double Stents are

·         Increased procedural time.

·         Technical difficulty in placing two stents.

·         Theoretical increase in cost and risk of post-ERCP pancreatitis or cholangitis.

There is currently no randomized trial comparing single vs double DPT stents in a homogenous population undergoing ERCP for biliary drainage—whether in benign strictures, pre-operative decompression, or palliative settings. There is lack of consensus or guideline recommendations on optimal number of plastic stents in ERCP for non-hilar obstruction.

 
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