| 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
|
|
|
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
|
|
|
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
|
|
|
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. |