Pancreatic StentingNCT05431517
Incidence, Risk Factors and Endoscopic Retrieval of Proximally Migrated Pancreatic Stents
An observational study of Pancreatic Stenting and Pancreatic Stent Displacement, run by Changhai Hospital at 1 site in China.
Trial summary
This study intends to determine the incidence, risk factors and endoscopic treatment of proximally migrated pancreatic stents. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Stenting, Pancreatic Stent Displacement
- What is being tested?
- Analysis of ERCP records
- Type of treatment
- Surgery or procedure
- How many people
- 9,073 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2022to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with placements of pancreatic stents under ERCP.
Who may be able to join
- Pancreatic stent placement under ERCP;
- Pancreatic stent migration found by ERCP;
- Displaced pancreatic stent removal by ERCP technique.
Who cannot join
- Incomplete ERCP records (e.g., missing stent size information);
- Immediate removal of pancreatic stent following implantation for a variety of reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence, Risk Factors and Endoscopic Retrieval of Proximally Migrated Pancreatic Stents: 25 Years of Experience in a Tertiary Center
This study intends to determine the incidence, risk factors and endoscopic treatment of proximally migrated pancreatic stents.
Read the detailed description
Endoscopic pancreatic stenting can be used to treat a variety of pancreatic disorders, including chronic pancreatitis-induced pancreatic duct stenosis, pancreatic schizophrenia, pancreatic leakage, pancreatic pseudocyst drainage, and prophylactic pancreatic duct stenting. Postoperative stent migration is one of the complications associated with pancreatic stent placement.
In this retrospective study, more than 9,000 Endoscopic retrograde cholangiopancreatography (ERCP) cases at our center over the past 25 years will be analyzed to determine the incidence, risk factors and endoscopic treatment of proximally migrated pancreatic stents.
- Conditions
- Pancreatic Stenting, Pancreatic Stent Displacement
- Being tested
- Analysis of ERCP records
- Keywords
- Endoscopic retrograde cholangiopancreatography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of ERCP recordsProcedure or surgery
Data will be extracted from ERCP records of stenting, mainly including: 1) Age at the time of ERCP; 2) Gender; 3) Indication; 4) Papilla selection (major or minor); 5) Whether endoscopic sphincterotomy (EST) was performed; 6) Presence of nipple diverticulum; 7) Morphology of the pancreatic duct; 8) Status of pancreatic duct stones; 9) Number, shape, material, diameter and length of the stent; and 10) Operation of the bile duct. Additional data were extracted from the pertinent ERCP records of stent migration: 1) Shape, material, diameter and length of the displaced stent; 2) Type of migration; and 3) Removal tools.
| Study group | Role | What they receive |
|---|---|---|
| Non-migration group | Cases without migration after pancreatic stenting under ERCP. Receives: Procedure: Analysis of ERCP records | |
| Migration group | Cases with migration after pancreatic stenting under ERCP. Receives: Procedure: Analysis of ERCP records |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of proximally migrated pancreatic stents
Measured: Within 1 month after data analysis
Success rate of endoscopic removal of migrated pancreatic stents
Measured: Within 1 month after data analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start30 Jun 2022
- Primary completion1 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic StentingStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 9,073 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Liang-hao Hu, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431517
- Sponsor's protocol ID
- IREPS20220611
- Status last verified
- Sep 2022
- First submitted
- 19 Jun 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Risk Factors and Endoscopic Retrieval of Proximally Migrated Pancreatic Stents: 25 Years of Experience in a Tertiary Center
- ClinicalTrials.gov ID
- NCT05431517
- Acronym / sponsor ID
- IREPS20220611
- Conditions
- Pancreatic Stenting, Pancreatic Stent Displacement
- Keywords
- Endoscopic retrograde cholangiopancreatography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,073 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 24 Jun 2022 (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.
This study intends to determine the incidence, risk factors and endoscopic treatment of proximally migrated pancreatic stents.
Detailed description
Endoscopic pancreatic stenting can be used to treat a variety of pancreatic disorders, including chronic pancreatitis-induced pancreatic duct stenosis, pancreatic schizophrenia, pancreatic leakage, pancreatic pseudocyst drainage, and prophylactic pancreatic duct stenting. Postoperative stent migration is one of the complications associated with pancreatic stent placement.
In this retrospective study, more than 9,000 Endoscopic retrograde cholangiopancreatography (ERCP) cases at our center over the past 25 years will be analyzed to determine the incidence, risk factors and endoscopic treatment of proximally migrated pancreatic stents.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-migration group | – | Procedure: Analysis of ERCP recordsCases without migration after pancreatic stenting under ERCP. |
| Migration group | – | Procedure: Analysis of ERCP recordsCases with migration after pancreatic stenting under ERCP. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with placements of pancreatic stents under ERCP.
Key inclusion criteria (3 listed)
- Pancreatic stent placement under ERCP;
- Pancreatic stent migration found by ERCP;
- Displaced pancreatic stent removal by ERCP technique.
Key exclusion criteria (2 listed)
- Incomplete ERCP records (e.g., missing stent size information);
- Immediate removal of pancreatic stent following implantation for a variety of reasons.
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 |
|---|---|---|
| Analysis of ERCP recordsData will be extracted from ERCP records of stenting, mainly including: 1) Age at the time of ERCP; 2) Gender; 3) Indication; 4) Papilla selection (major or minor); 5) Whether endoscopic sphincterotomy (EST) was performed; 6) Presence of nipple diverticulum; 7) Morphology of the pancreatic duct; 8) Status of pancreatic duct stones; 9) Number, shape, material, diameter and length of the stent; and 10) Operation of the bile duct. Additional data were extracted from the pertinent ERCP records of stent migration: 1) Shape, material, diameter and length of the displaced stent; 2) Type of migration; and 3) Removal tools. | Procedure or surgery | Migration group, Non-migration group |
Primary outcome
Incidence of proximally migrated pancreatic stents
Time frame: Within 1 month after data analysis
Success rate of endoscopic removal of migrated pancreatic stents
Time frame: Within 1 month after data analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Liang-hao Hu, MD principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Stenting and Pancreatic Stent Displacement, run by Changhai Hospital at 1 site in China.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of proximally migrated pancreatic stents (time frame: Within 1 month after data analysis). The study lists 2 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 14 Sep 2022.