CholangitisNCT04691674
Optimal Placement Duration of Pancreatic Duct Stent
A study testing Endoscopy in people with Cholangitis and Post-ERCP Acute Pancreatitis, run by DongGuk University at 1 site in South Korea.
Trial summary
A randomized controlled trial to determine the optimal placement duration of pancreatic duct stents (PDS) inserted during ERCP: 2 vs 4 weeks Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cholangitis, Post-ERCP Acute Pancreatitis, Stent Dislodgement
- What is being tested?
- Endoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2021to 31 Aug 2024
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent the pancreatic duct stent placement during ERCP
Who cannot join
- Patients who had pancreatic duct stent for the purpose of pancreatic interventions
- Patients who underwent simultaneous bile duct stenting
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, 10326
About this study
Official title: Optimal Placement Duration of Pancreatic Duct Stent Inserted During ERCP: 2 vs 4 Weeks
A randomized controlled trial to determine the optimal placement duration of pancreatic duct stents (PDS) inserted during ERCP: 2 vs 4 weeks
Read the detailed description
Endoscopic pancreatic duct stenting has been increasingly used for the treatment of a variety of pancreatic disorders including chronic pancreatitis, pancreatic duct stricture, drainage of pseudocysts, and the prevention of pancreatitis following endoscopic retrograde cholangiopancreatography (ERCP). Several randomized, controlled trials and meta-analyses have proven a significant reduction in incidence and severity of post-ERCP pancreatitis (PEP) with prophylactic pancreatic duct stenting. The US and European guidelines recommend that pancreatic duct stents (PDS) be placed between 7-10 days and 5-10 days, respectively, in order to prevent PEP in some situations. Therefore, the placement of PDS has been an established essential procedure for preventing a fatal complication, PEP. Furthermore, PDS placement can facilitate difficult common bile duct cannulation. It may help not only to straighten papillary anatomy but also to identify the location of the biliary orifice.
However, PDS tends to become occluded easily due to protein content, calcium carbonate crystals, and bacteria in the pancreatic juice. The occluded PDS can cause acute pancreatitis or abdominal pain. For this reason, the guidelines recommend PDS be placed within 10 days. Because of this policy, the patient must take the inconvenience of undergoing another endoscopic procedure to remove the PDS. However, all patients with occluded PDS do not have symptoms such as pain. In one series, only 6 percent of patients with clogged PDS developed symptoms. The low incidence of symptoms despite a high rate of stent occlusion suggests that the stent may function as a wick around which pancreatic juices continue to drain. In addition, the rate of spontaneous stent dislodgement was relatively high (65-86%) within 30 days according to a previous study. A recent study also reported that prolonged retention of prophylactic pancreatic stents is not associated with increased complications.
Taken together, PDS placed during ERCP do not need to be removed until any symptom develops. In particular, if the investigators can observe PDS for about a month without removing them, the PDS are more likely to pass out spontaneously, which could reduce unnecessary procedures. However, to date, there have been few randomized controlled studies on the optimal placement duration of PDS inserted during ERCP.
- Being tested
- Endoscopy
- Medical subject headings
- Cholangitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoscopyProcedure or surgery
Endoscopic removal of the pancreatic stent
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Endoscopic removal of pancreatic duct stent at 4 weeks following ERCP, unless spontaneously dislodged. Receives: Procedure: Endoscopy |
| Control group | Placebo comparator | Endoscopic removal of pancreatic duct stent at 2 weeks following ERCP, unless spontaneously dislodged. Receives: Procedure: Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with undergoing endoscopic procedures
The necessity of endoscopic procedure for pancreatic duct stent removal
Measured: 2 weeks (control group) or 4 weeks (study group) following ERCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start1 Feb 2021
- Primary completion31 Jul 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for CholangitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- DongGuk University
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Hospital, Gachon University Gil Medical Center, Gyeongsang National University Hospital, Kyungpook National University Hospital, Severance Hospital, The Catholic University of Korea, Korea University Ansan Hospital, Pusan National University Hospital
- Responsible party
- Principal investigator, Dong Kee Jang, DongGuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691674
- Sponsor's protocol ID
- 2020-10-024-003
- Status last verified
- Dec 2024
- First submitted
- 28 Dec 2020
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mazaki T, Mado K, Masuda H, Shiono M. Prophylactic pancreatic stent placement and post-ERCP pancreatitis: an updated meta-analysis. J Gastroenterol. 2014 Feb;49(2):343-55. doi: 10.1007/s00535-013-0806-1. Epub 2013 Apr 24.
PubMed 23612857Choudhary A, Bechtold ML, Arif M, Szary NM, Puli SR, Othman MO, Pais WP, Antillon MR, Roy PK. Pancreatic stents for prophylaxis against post-ERCP pancreatitis: a meta-analysis and systematic review. Gastrointest Endosc. 2011 Feb;73(2):275-82. doi: 10.1016/j.gie.2010.10.039.
PubMed 21295641ASGE Standards of Practice Committee; Chandrasekhara V, Khashab MA, Muthusamy VR, Acosta RD, Agrawal D, Bruining DH, Eloubeidi MA, Fanelli RD, Faulx AL, Gurudu SR, Kothari S, Lightdale JR, Qumseya BJ, Shaukat A, Wang A, Wani SB, Yang J, DeWitt JM. Adverse events associated with ERCP. Gastrointest Endosc. 2017 Jan;85(1):32-47. doi: 10.1016/j.gie.2016.06.051. Epub 2016 Aug 18. No abstract available.
PubMed 27546389Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.
PubMed 31863440Goldberg E, Titus M, Haluszka O, Darwin P. Pancreatic-duct stent placement facilitates difficult common bile duct cannulation. Gastrointest Endosc. 2005 Oct;62(4):592-6. doi: 10.1016/j.gie.2005.04.046.
PubMed 16185975Deviere J. Why do pancreatic stents become occluded? Gastrointest Endosc. 2005 Jun;61(7):867-8. doi: 10.1016/s0016-5107(05)00548-1. No abstract available.
PubMed 15933689Ikenberry SO, Sherman S, Hawes RH, Smith M, Lehman GA. The occlusion rate of pancreatic stents. Gastrointest Endosc. 1994 Sep-Oct;40(5):611-3. doi: 10.1016/s0016-5107(94)70264-0. No abstract available.
PubMed 7988829Rashdan A, Fogel EL, McHenry L Jr, Sherman S, Temkit M, Lehman GA. Improved stent characteristics for prophylaxis of post-ERCP pancreatitis. Clin Gastroenterol Hepatol. 2004 Apr;2(4):322-9. doi: 10.1016/s1542-3565(04)00062-x.
PubMed 15067627Dultz G, Gerber L, Zeuzem S, Bojunga J, Friedrich-Rust M. Prolonged retention of prophylactic pancreatic stents is not associated with increased complications. Pancreatology. 2019 Jan;19(1):39-43. doi: 10.1016/j.pan.2018.11.011. Epub 2018 Nov 22.
PubMed 30502123Jang DK, Choi YH, Kim EJ, Lee JM, Choe JW, Han SY, Lee J, Jo JH, Jung MK, Lee SH; Pancreas Study Group of the Korean Pancreatobiliary Association. Optimal Retention Duration of Prophylactic Pancreatic Duct Stents Placed During Endoscopic Retrograde Cholangiopancreatography: A Multicenter Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2026 Jun 22:S1542-3565(26)00479-9. doi: 10.1016/j.cgh.2026.06.022. Online ahead of print.
PubMed 42331078
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Placement Duration of Pancreatic Duct Stent Inserted During ERCP: 2 vs 4 Weeks
- ClinicalTrials.gov ID
- NCT04691674
- Acronym / sponsor ID
- 2020-10-024-003
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- DongGuk UniversityUniversity, hospital or other
- Collaborators
- Seoul National University Hospital, Gachon University Gil Medical Center, Gyeongsang National University Hospital, Kyungpook National University Hospital, Severance Hospital, The Catholic University of Korea, Korea University Ansan Hospital, Pusan National University Hospital
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 31 Dec 2020 (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.
A randomized controlled trial to determine the optimal placement duration of pancreatic duct stents (PDS) inserted during ERCP: 2 vs 4 weeks
Detailed description
Endoscopic pancreatic duct stenting has been increasingly used for the treatment of a variety of pancreatic disorders including chronic pancreatitis, pancreatic duct stricture, drainage of pseudocysts, and the prevention of pancreatitis following endoscopic retrograde cholangiopancreatography (ERCP). Several randomized, controlled trials and meta-analyses have proven a significant reduction in incidence and severity of post-ERCP pancreatitis (PEP) with prophylactic pancreatic duct stenting. The US and European guidelines recommend that pancreatic duct stents (PDS) be placed between 7-10 days and 5-10 days, respectively, in order to prevent PEP in some situations. Therefore, the placement of PDS has been an established essential procedure for preventing a fatal complication, PEP. Furthermore, PDS placement can facilitate difficult common bile duct cannulation. It may help not only to straighten papillary anatomy but also to identify the location of the biliary orifice.
However, PDS tends to become occluded easily due to protein content, calcium carbonate crystals, and bacteria in the pancreatic juice. The occluded PDS can cause acute pancreatitis or abdominal pain. For this reason, the guidelines recommend PDS be placed within 10 days. Because of this policy, the patient must take the inconvenience of undergoing another endoscopic procedure to remove the PDS. However, all patients with occluded PDS do not have symptoms such as pain. In one series, only 6 percent of patients with clogged PDS developed symptoms. The low incidence of symptoms despite a high rate of stent occlusion suggests that the stent may function as a wick around which pancreatic juices continue to drain. In addition, the rate of spontaneous stent dislodgement was relatively high (65-86%) within 30 days according to a previous study. A recent study also reported that prolonged retention of prophylactic pancreatic stents is not associated with increased complications.
Taken together, PDS placed during ERCP do not need to be removed until any symptom develops. In particular, if the investigators can observe PDS for about a month without removing them, the PDS are more likely to pass out spontaneously, which could reduce unnecessary procedures. However, to date, there have been few randomized controlled studies on the optimal placement duration of PDS inserted during ERCP.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: EndoscopyEndoscopic removal of pancreatic duct stent at 4 weeks following ERCP, unless spontaneously dislodged. |
| Control group | Placebo comparator | Procedure: EndoscopyEndoscopic removal of pancreatic duct stent at 2 weeks following ERCP, unless spontaneously dislodged. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who underwent the pancreatic duct stent placement during ERCP
Key exclusion criteria (2 listed)
- Patients who had pancreatic duct stent for the purpose of pancreatic interventions
- Patients who underwent simultaneous bile duct stenting
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 |
|---|---|---|
| EndoscopyEndoscopic removal of the pancreatic stent | Procedure or surgery | Control group, Study group |
Primary outcome
Number of participants with undergoing endoscopic procedures
Time frame: 2 weeks (control group) or 4 weeks (study group) following ERCP
The necessity of endoscopic procedure for pancreatic duct stent removal
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 9 Dec 2024.
- Results publication: PubMed 23612857Mazaki T, Mado K, Masuda H, Shiono M. Prophylactic pancreatic stent placement and post-ERCP pancreatitis: an updated meta-analysis. J Gastroenterol. 2014 Feb;49(2):343-55. doi: 10.1007/s00535-013-0806-1. Epub 2013 Apr 24.
- Results publication: PubMed 21295641Choudhary A, Bechtold ML, Arif M, Szary NM, Puli SR, Othman MO, Pais WP, Antillon MR, Roy PK. Pancreatic stents for prophylaxis against post-ERCP pancreatitis: a meta-analysis and systematic review. Gastrointest Endosc. 2011 Feb;73(2):275-82. doi: 10.1016/j.gie.2010.10.039.
- Results publication: PubMed 27546389ASGE Standards of Practice Committee; Chandrasekhara V, Khashab MA, Muthusamy VR, Acosta RD, Agrawal D, Bruining DH, Eloubeidi MA, Fanelli RD, Faulx AL, Gurudu SR, Kothari S, Lightdale JR, Qumseya BJ, Shaukat A, Wang A, Wani SB, Yang J, DeWitt JM. Adverse events associated with ERCP. Gastrointest Endosc. 2017 Jan;85(1):32-47. doi: 10.1016/j.gie.2016.06.051. Epub 2016 Aug 18. No abstract available.
- Results publication: PubMed 31863440Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.
- Results publication: PubMed 16185975Goldberg E, Titus M, Haluszka O, Darwin P. Pancreatic-duct stent placement facilitates difficult common bile duct cannulation. Gastrointest Endosc. 2005 Oct;62(4):592-6. doi: 10.1016/j.gie.2005.04.046.
- Results publication: PubMed 15933689Deviere J. Why do pancreatic stents become occluded? Gastrointest Endosc. 2005 Jun;61(7):867-8. doi: 10.1016/s0016-5107(05)00548-1. No abstract available.
- Results publication: PubMed 7988829Ikenberry SO, Sherman S, Hawes RH, Smith M, Lehman GA. The occlusion rate of pancreatic stents. Gastrointest Endosc. 1994 Sep-Oct;40(5):611-3. doi: 10.1016/s0016-5107(94)70264-0. No abstract available.
- Results publication: PubMed 15067627Rashdan A, Fogel EL, McHenry L Jr, Sherman S, Temkit M, Lehman GA. Improved stent characteristics for prophylaxis of post-ERCP pancreatitis. Clin Gastroenterol Hepatol. 2004 Apr;2(4):322-9. doi: 10.1016/s1542-3565(04)00062-x.
- Results publication: PubMed 30502123Dultz G, Gerber L, Zeuzem S, Bojunga J, Friedrich-Rust M. Prolonged retention of prophylactic pancreatic stents is not associated with increased complications. Pancreatology. 2019 Jan;19(1):39-43. doi: 10.1016/j.pan.2018.11.011. Epub 2018 Nov 22.
- Derived from this study: PubMed 42331078Jang DK, Choi YH, Kim EJ, Lee JM, Choe JW, Han SY, Lee J, Jo JH, Jung MK, Lee SH; Pancreas Study Group of the Korean Pancreatobiliary Association. Optimal Retention Duration of Prophylactic Pancreatic Duct Stents Placed During Endoscopic Retrograde Cholangiopancreatography: A Multicenter Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2026 Jun 22:S1542-3565(26)00479-9. doi: 10.1016/j.cgh.2026.06.022. Online ahead of print.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopy in people with Cholangitis and Post-ERCP Acute Pancreatitis, run by DongGuk University at 1 site in South Korea.
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 1 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 9 Dec 2024. 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
Number of participants with undergoing endoscopic procedures (time frame: 2 weeks (control group) or 4 weeks (study group) following ERCP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04691674, which also lists 10 linked publications.
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 9 Dec 2024.