Pancreatic Duct StentingNCT06900790
Management of Pediatric Pancreatic Calculi At a Single Center: a Retrospective Cohort Study
An observational study of Pancreatic Duct Stenting and ERCP, run by Yifan Deng.
Trial summary
The goal of this observational study is to evaluate the long-term effects of ERCP and surgery in pediatric patients with pancreatic duct stones. The main objective is to determine the optimal treatment choice(ERCP or surgery) for children with pancreatic duct stones and identify the appropriate timing for surgery in… Read more about this study
- Who is it for?
- Ages 2 months to 18 years
- Conditions the study is for
- Pancreatic Duct Stenting, ERCP, Surgery in Early Childhood
- What is being tested?
- ERCP
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 23 Apr 2025to 23 Dec 2025
- Phase
- Observational
- 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 2 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and adolescents (≤18 years old) diagnosed with pancreatic duct stones between 2015 and 2025 at a single tertiary care center. Data includes patients who underwent ERCP or surgery when the first treatment.
Who may be able to join
- Patients aged 0 to 18 years
- Diagnosed with pancreatic duct stones by imaging (e.g., ultrasound, CT, MRCP)
- Treated and followed at pediatric surgery, west china hospital, between 2014 and 2025
- Complete clinical data available for review
Who cannot join
- Pancreatic duct stones secondary to previous pancreatic or biliary surgery
- Concurrent severe systemic diseases (e.g., advanced cardiac, renal, or hepatic disease)
- Incomplete or missing key clinical records
About this study
Official title: A Single-Center Retrospective Cohort Study Evaluating the Management and Outcomes of Pediatric Pancreatic Duct Stones Using Endoscopic and Surgical Techniques
The goal of this observational study is to evaluate the long-term effects of ERCP and surgery in pediatric patients with pancreatic duct stones. The main objective is to determine the optimal treatment choice(ERCP or surgery) for children with pancreatic duct stones and identify the appropriate timing for surgery in patients who have undergone multiple ERCP procedures, in order to avoid adverse outcomes caused by repeated trauma to the duodenal papilla.
Last updated on January 24, 2025.
- Being tested
- ERCP
- Keywords
- pancreatic duct stones, ERCP, Frey surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCPProcedure or surgery
Also called Frey surgery
There are two intervention methods for pediatric pancreatic duct stones. One is to remove the pancreatic duct stones through Endoscopic Retrograde Cholangiopancreatography(ERCP), while simultaneously dilating the pancreatic duct and placing a stent to assist in the normal drainage of pancreatic juice. The other is local resection of the pancreatic head combined with longitudinal pancreaticojejunostomy (Frey surgery).
| Study group | Role | What they receive |
|---|---|---|
| ERCP group | Pediatric pancreatic duct stone patients who underwent ERCP to restore pancreatic duct patency. Receives: Procedure: ERCP | |
| Surgery group | Pediatric pancreatic duct stone patients who underwent Frey surgery. Receives: Procedure: ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone clearance
The stone clearance rate refers to the proportion of patients confirmed by postoperative imaging (MRCP) to have no residual pancreatic duct stones.
Measured: From intervention to the end of treatment at 1 week
complication rate
The complication rate refers to the incidence of pancreatitis following ERCP and associated procedures, as well as pancreatic fistula, bile leakage, and the necessity for prolonged drainage after the Frey procedure.
Measured: From enrollment to the end of treatment at 2 weeks
reintervention rate
The reintervention rate refers to the proportion of patients who required additional invasive procedures (either ERCP or surgery) after the initial treatment.
Measured: From enrollment to the end of treatment at 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start23 Apr 2025 (estimated)
- Primary completion23 Dec 2025 (estimated)
- Study completion23 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Duct StentingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yifan Deng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yifan Deng, West China Second University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900790
- Sponsor's protocol ID
- Ethical No. 2024 Review (35)
- Status last verified
- Mar 2025
- First submitted
- 23 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Retrospective Cohort Study Evaluating the Management and Outcomes of Pediatric Pancreatic Duct Stones Using Endoscopic and Surgical Techniques
- ClinicalTrials.gov ID
- NCT06900790
- Acronym / sponsor ID
- Ethical No. 2024 Review (35)
- Keywords
- pancreatic duct stones, ERCP, Frey surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yifan DengUniversity, hospital or other
- Study start
- 23 Apr 2025 (estimated)
- Primary completion
- 23 Dec 2025 (estimated)
- Study completion
- 23 Dec 2025 (estimated)
- First posted
- 28 Mar 2025 (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.
The goal of this observational study is to evaluate the long-term effects of ERCP and surgery in pediatric patients with pancreatic duct stones. The main objective is to determine the optimal treatment choice(ERCP or surgery) for children with pancreatic duct stones and identify the appropriate timing for surgery in patients who have undergone multiple ERCP procedures, in order to avoid adverse outcomes caused by repeated trauma to the duodenal papilla.
Last updated on January 24, 2025.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERCP group | – | Procedure: ERCPPediatric pancreatic duct stone patients who underwent ERCP to restore pancreatic duct patency. |
| Surgery group | – | Procedure: ERCPPediatric pancreatic duct stone patients who underwent Frey surgery. |
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents (≤18 years old) diagnosed with pancreatic duct stones between 2015 and 2025 at a single tertiary care center. Data includes patients who underwent ERCP or surgery when the first treatment.
Key inclusion criteria (4 listed)
- Patients aged 0 to 18 years
- Diagnosed with pancreatic duct stones by imaging (e.g., ultrasound, CT, MRCP)
- Treated and followed at pediatric surgery, west china hospital, between 2014 and 2025
- Complete clinical data available for review
Key exclusion criteria (3 listed)
- Pancreatic duct stones secondary to previous pancreatic or biliary surgery
- Concurrent severe systemic diseases (e.g., advanced cardiac, renal, or hepatic disease)
- Incomplete or missing key clinical records
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 |
|---|---|---|
| ERCPAlso: Frey surgeryThere are two intervention methods for pediatric pancreatic duct stones. One is to remove the pancreatic duct stones through Endoscopic Retrograde Cholangiopancreatography(ERCP), while simultaneously dilating the pancreatic duct and placing a stent to assist in the normal drainage of pancreatic juice. The other is local resection of the pancreatic head combined with longitudinal pancreaticojejunostomy (Frey surgery). | Procedure or surgery | ERCP group, Surgery group |
Primary outcome
stone clearance
Time frame: From intervention to the end of treatment at 1 week
The stone clearance rate refers to the proportion of patients confirmed by postoperative imaging (MRCP) to have no residual pancreatic duct stones.
complication rate
Time frame: From enrollment to the end of treatment at 2 weeks
The complication rate refers to the incidence of pancreatitis following ERCP and associated procedures, as well as pancreatic fistula, bile leakage, and the necessity for prolonged drainage after the Frey procedure.
reintervention rate
Time frame: From enrollment to the end of treatment at 1 year.
The reintervention rate refers to the proportion of patients who required additional invasive procedures (either ERCP or surgery) after the initial treatment.
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 28 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Duct Stenting and ERCP, run by Yifan Deng.
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 4 inclusion and 3 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 28 Mar 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stone clearance (time frame: From intervention to the end of treatment at 1 week). The study lists 3 primary outcomes in all. 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 28 Mar 2025.