Sphincterotomy, EndoscopicNCT05896280
Effect of ECPP on Recurrent Bile Duct Stones
A study testing EST and ECPP in people with Sphincterotomy, Endoscopic, run by Peking University Third Hospital at 1 site in China.
Trial summary
Endoscopic retrograde cholangiopancreatography (ERCP) combined with endoscopic papillary sphinctomy (EST) is the preferred clinical treatment for common bile duct stones, and this minimally invasive treatment technique has been widely used in clinical practice for decades. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sphincterotomy, Endoscopic
- What is being tested?
- EST and ECPP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 31 Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Imaging confirms the presence of common bile duct stones.
- Common bile duct stones ≥ 1.0 cm in length.
- Common bile duct inner diameter≥1.2cm.
- The patient agrees to participate in the trial and signs the informed consent form.
Who cannot join
- Combined with coagulation dysfunction.
- heart, lung, kidney or other serious organic diseases.
- Patients with severe psychiatric illness.
- Previous papillary sphincterotomy.
- Patients who cannot cooperate with the completion of this study.
- Those with a life expectancy of less than 1 year and may not be able to complete follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100101
Yonghui Huang, archiater, 13911765322, chengzhuopku@163.com
About this study
Official title: Effects of Endoclip Papilloplasty and Relationship Between Post-operative Microecological Environment and Recurrent Bile Duct Stones
Endoscopic retrograde cholangiopancreatography (ERCP) combined with endoscopic papillary sphinctomy (EST) is the preferred clinical treatment for common bile duct stones, and this minimally invasive treatment technique has been widely used in clinical practice for decades. However, even after successful stone removal by EST combined with various methods, the incidence of postoperative recurrent bile duct stones can still be as high as 9.8%~30% . The emergence of these long-term complications after EST surgery is currently thought to be related to the loss of Oddi sphincter function. In clinical practice, the investigators tried a new method to repair the Oddi sphincter, that is, after ERCP+EST stone removal, a metal clip was inserted into the endoscopic clamp through the duodenoscopy, and clamp precisely on both lateral edges of the nipple after incision. This procedure is called endoscopic nipple clipping (ECPP). Initial explorations in animal and human trials showed good results, with 3 weeks after clipping of the incised nipple not only showing scar repair of the nipple shape and structure, but also confirmed the recovery of sphincter function by Oddi sphincter manometry, the Oddi's sphincter basal pressure, contraction frequency and contraction amplitude were able to return to the pre-EST level. In summary, the investigators designed a single-center randomized controlled trial to explore and verify the clinical effect of ECPP on the prevention of recurrent bile duct stones within one year by comparing the incidence of recurrent bile duct stones within one year after EST surgery. By observing the changes of intestinal biliary reflux, biliary bacterial colonization, biliary microecology and bile metabolism after EST surgery, the pathogenesis of long-term complications such as recurrent bile duct stones after EST surgery was further sought.
Read the detailed description
Endoscopic retrograde cholangiopancreatography (ERCP) combined with endoscopic papillary sphinctomy (EST) is the preferred clinical treatment for common bile duct stones, and this minimally invasive treatment technique has been widely used in clinical practice for decades. However, even after successful stone removal by EST combined with various methods, the incidence of postoperative recurrent bile duct stones can still be as high as 9.8%~30% . The emergence of these long-term complications after EST surgery is currently thought to be related to the loss of Oddi sphincter function. EST sphincterotomy results in destruction of the Oddi sphincter structure, which in turn causes dysfunction and reflux of intestinal contents into the biliary tract (biliary reflux). In clinical practice, the investigators tried a new method to repair the Oddi sphincter, that is, after ERCP+EST stone removal, a metal clip was inserted into the endoscopic clamp through the duodenoscopy, and clamp precisely on both lateral edges of the nipple after incision. Initial explorations in animal and human trials showed good results, with 3 weeks after clipping of the incised nipple not only showing scar repair of the nipple shape and structure, but also confirmed the recovery of sphincter function by Oddi sphincter manometry, the Oddi's sphincter basal pressure, contraction frequency and contraction amplitude were able to return to the pre-EST level.
the investigators designed a single-center randomized controlled trial to explore and verify the clinical effect of ECPP on the prevention of recurrent bile duct stones within one year by comparing the incidence of recurrent bile duct stones within one year after EST surgery. This prospective study will be performed at 1 tertiary hospitals in China. The investigators will recruit patients according to admission criteria and exclusion criteria. The patients will be randomized (at a 1:1 ratio) to endoscopic papillary sphinctomy (EST) group (control group) and endoscopic nipple clipping (ECPP) group (experimental group). The control groups will be followed by routine EST stone removal, the patient's postoperative nipple is in a post-incision state; The experimental group underwent ECPP after EST. The primary endpoint is the incidence of recurrent bile duct stones. The secondary outcomes include the mortality of each group, adverse events and the rate of technical success.
- Conditions
- Sphincterotomy, Endoscopic
- Being tested
- EST, ECPP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESTProcedure or surgery
Stones are taken by cutting the papillary sphincter
ECPPProcedure or surgery
During ERCP, a generous biliary sphincterotomy (>1 cm) will be performed to facilitate large stone extraction by use of a lithotripsy basket and a stone extraction balloon. After all stone fragments were cleared from the bile duct, this group will undergo ECPP after EST. A single-pigtail biliary stent will be placed (suspended overlength biliary stent, 7F × 20 cm). Then the rotatable repeatable opening and closing of soft tissue clamps (referred to as harmony clips, Mico-Tech, ROCC-D-26-195) should be applied to extend the bile duct axially, linear clamp the incised duodenal papilla, taking care to avoid clamping the bile duct stent, and removing the bile duct stent 3 weeks after ECPP.
| Study group | Role | What they receive |
|---|---|---|
| EST in common bile duct stones | Active comparator | With routine EST surgery, the sphincter is cut open and stones are removed Receives: Procedure: EST |
| ECPP in common bile duct stones | Experimental | Common bile duct stones are removed after EST, and then ECPP is performed. Receives: Procedure: EST; Procedure: ECPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent bile duct stones
The patient developed a recurrence of common bile duct stones within 1 year after surgery. Signs of recurrent bile duct stones include symptoms of cholangitis such as abdominal pain, fever, jaundice, or re-elevation of direct bilirubin/GGT/ALP or simple imaging of common bile duct stones.
Measured: 12 months after ERCP
Secondary outcomes (1)
Death or adverse events
The patient dies or develops postoperative complications of ERCP, stent displacement, detachment, etc., failure of ERCP.
Measured: 12 months after ERCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start1 Dec 2022
- Primary completion1 Aug 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Sphincterotomy, EndoscopicStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yonghui Huang, archiater, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896280
- Sponsor's protocol ID
- LM2023425
- Status last verified
- Oct 2022
- First submitted
- 31 May 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kageoka M, Watanabe F, Maruyama Y, Nagata K, Ohata A, Noda Y, Miwa I, Ikeya K. Long-term prognosis of patients after endoscopic sphincterotomy for choledocholithiasis. Dig Endosc. 2009 Jul;21(3):170-5. doi: 10.1111/j.1443-1661.2009.00880.x.
PubMed 19691764Nzenza TC, Al-Habbal Y, Guerra GR, Manolas S, Yong T, McQuillan T. Recurrent common bile duct stones as a late complication of endoscopic sphincterotomy. BMC Gastroenterol. 2018 Mar 15;18(1):39. doi: 10.1186/s12876-018-0765-3.
PubMed 29544453Tanaka M, Takahata S, Konomi H, Matsunaga H, Yokohata K, Takeda T, Utsunomiya N, Ikeda S. Long-term consequence of endoscopic sphincterotomy for bile duct stones. Gastrointest Endosc. 1998 Nov;48(5):465-9. doi: 10.1016/s0016-5107(98)70086-0.
PubMed 9831833Yang J, Jin H, Gu W, Zhang X, Zhang X. Determinants of long-term complications of endoscopic sphincterotomy are infections and high risk factors of bile duct and not sphincter of Oddi dysfunction. Eur J Gastroenterol Hepatol. 2015 Apr;27(4):412-8. doi: 10.1097/MEG.0000000000000295.
PubMed 25874514Costamagna G, Tringali A, Shah SK, Mutignani M, Zuccala G, Perri V. Long-term follow-up of patients after endoscopic sphincterotomy for choledocholithiasis, and risk factors for recurrence. Endoscopy. 2002 Apr;34(4):273-9. doi: 10.1055/s-2002-23632.
PubMed 11932781Sugiyama M, Atomi Y. Risk factors predictive of late complications after endoscopic sphincterotomy for bile duct stones: long-term (more than 10 years) follow-up study. Am J Gastroenterol. 2002 Nov;97(11):2763-7. doi: 10.1111/j.1572-0241.2002.07019.x.
PubMed 12425545Mortensen FV, Jepsen P, Tarone RE, Funch-Jensen P, Jensen LS, Sorensen HT. Endoscopic sphincterotomy and long-term risk of cholangiocarcinoma: a population-based follow-up study. J Natl Cancer Inst. 2008 May 21;100(10):745-50. doi: 10.1093/jnci/djn102. Epub 2008 May 13.
PubMed 18477806Stromberg C, Luo J, Enochsson L, Arnelo U, Nilsson M. Endoscopic sphincterotomy and risk of malignancy in the bile ducts, liver, and pancreas. Clin Gastroenterol Hepatol. 2008 Sep;6(9):1049-53. doi: 10.1016/j.cgh.2008.04.016. Epub 2008 Jun 30.
PubMed 18585972Afghani E, Lo SK, Covington PS, Cash BD, Pandol SJ. Sphincter of Oddi Function and Risk Factors for Dysfunction. Front Nutr. 2017 Jan 30;4:1. doi: 10.3389/fnut.2017.00001. eCollection 2017.
PubMed 28194398Mandryka Y, Klimczak J, Duszewski M, Kondras M, Modzelewski B. [Bile duct infections as a late complication after endoscopic sphincterotomy]. Pol Merkur Lekarski. 2006 Dec;21(126):525-7. Polish.
PubMed 17405290Yasuda I, Fujita N, Maguchi H, Hasebe O, Igarashi Y, Murakami A, Mukai H, Fujii T, Yamao K, Maeshiro K, Tada T, Tsujino T, Komatsu Y. Long-term outcomes after endoscopic sphincterotomy versus endoscopic papillary balloon dilation for bile duct stones. Gastrointest Endosc. 2010 Dec;72(6):1185-91. doi: 10.1016/j.gie.2010.07.006. Epub 2010 Sep 25.
PubMed 20869711Wang Y, Chang H, Zhang Y, Wang K, Zhang H, Yan X, Meng L, Yao W, Li K, Huang Y. Endoscopic endoclip papilloplasty preserves sphincter of oddi function. Eur J Clin Invest. 2021 Mar;51(3):e13408. doi: 10.1111/eci.13408. Epub 2020 Sep 22.
PubMed 32929751
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Endoclip Papilloplasty and Relationship Between Post-operative Microecological Environment and Recurrent Bile Duct Stones
- ClinicalTrials.gov ID
- NCT05896280
- Acronym / sponsor ID
- LM2023425
- Conditions
- Sphincterotomy, Endoscopic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Jun 2023 (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.
Endoscopic retrograde cholangiopancreatography (ERCP) combined with endoscopic papillary sphinctomy (EST) is the preferred clinical treatment for common bile duct stones, and this minimally invasive treatment technique has been widely used in clinical practice for decades. However, even after successful stone removal by EST combined with various methods, the incidence of postoperative recurrent bile duct stones can still be as high as 9.8%~30% . The emergence of these long-term complications after EST surgery is currently thought to be related to the loss of Oddi sphincter function. In clinical practice, the investigators tried a new method to repair the Oddi sphincter, that is, after ERCP+EST stone removal, a metal clip was inserted into the endoscopic clamp through the duodenoscopy, and clamp precisely on both lateral edges of the nipple after incision. This procedure is called endoscopic nipple clipping (ECPP). Initial explorations in animal and human trials showed good results, with 3 weeks after clipping of the incised nipple not only showing scar repair of the nipple shape and structure, but also confirmed the recovery of sphincter function by Oddi sphincter manometry, the Oddi's sphincter basal pressure, contraction frequency and contraction amplitude were able to return to the pre-EST level. In summary, the investigators designed a single-center randomized controlled trial to explore and verify the clinical effect of ECPP on the prevention of recurrent bile duct stones within one year by comparing the incidence of recurrent bile duct stones within one year after EST surgery. By observing the changes of intestinal biliary reflux, biliary bacterial colonization, biliary microecology and bile metabolism after EST surgery, the pathogenesis of long-term complications such as recurrent bile duct stones after EST surgery was further sought.
Detailed description
Endoscopic retrograde cholangiopancreatography (ERCP) combined with endoscopic papillary sphinctomy (EST) is the preferred clinical treatment for common bile duct stones, and this minimally invasive treatment technique has been widely used in clinical practice for decades. However, even after successful stone removal by EST combined with various methods, the incidence of postoperative recurrent bile duct stones can still be as high as 9.8%~30% . The emergence of these long-term complications after EST surgery is currently thought to be related to the loss of Oddi sphincter function. EST sphincterotomy results in destruction of the Oddi sphincter structure, which in turn causes dysfunction and reflux of intestinal contents into the biliary tract (biliary reflux). In clinical practice, the investigators tried a new method to repair the Oddi sphincter, that is, after ERCP+EST stone removal, a metal clip was inserted into the endoscopic clamp through the duodenoscopy, and clamp precisely on both lateral edges of the nipple after incision. Initial explorations in animal and human trials showed good results, with 3 weeks after clipping of the incised nipple not only showing scar repair of the nipple shape and structure, but also confirmed the recovery of sphincter function by Oddi sphincter manometry, the Oddi's sphincter basal pressure, contraction frequency and contraction amplitude were able to return to the pre-EST level.
the investigators designed a single-center randomized controlled trial to explore and verify the clinical effect of ECPP on the prevention of recurrent bile duct stones within one year by comparing the incidence of recurrent bile duct stones within one year after EST surgery. This prospective study will be performed at 1 tertiary hospitals in China. The investigators will recruit patients according to admission criteria and exclusion criteria. The patients will be randomized (at a 1:1 ratio) to endoscopic papillary sphinctomy (EST) group (control group) and endoscopic nipple clipping (ECPP) group (experimental group). The control groups will be followed by routine EST stone removal, the patient's postoperative nipple is in a post-incision state; The experimental group underwent ECPP after EST. The primary endpoint is the incidence of recurrent bile duct stones. The secondary outcomes include the mortality of each group, adverse events and the rate of technical success.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EST in common bile duct stones | Active comparator | Procedure: ESTWith routine EST surgery, the sphincter is cut open and stones are removed |
| ECPP in common bile duct stones | Experimental | Procedure: EST, Procedure: ECPPCommon bile duct stones are removed after EST, and then ECPP is performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Imaging confirms the presence of common bile duct stones.
- Common bile duct stones ≥ 1.0 cm in length.
- Common bile duct inner diameter≥1.2cm.
- The patient agrees to participate in the trial and signs the informed consent form.
Key exclusion criteria (6 listed)
- Combined with coagulation dysfunction.
- heart, lung, kidney or other serious organic diseases.
- Patients with severe psychiatric illness.
- Previous papillary sphincterotomy.
- Patients who cannot cooperate with the completion of this study.
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 |
|---|---|---|
| ESTStones are taken by cutting the papillary sphincter | Procedure or surgery | ECPP in common bile duct stones, EST in common bile duct stones |
| ECPPDuring ERCP, a generous biliary sphincterotomy (>1 cm) will be performed to facilitate large stone extraction by use of a lithotripsy basket and a stone extraction balloon. After all stone fragments were cleared from the bile duct, this group will undergo ECPP after EST. A single-pigtail biliary stent will be placed (suspended overlength biliary stent, 7F × 20 cm). Then the rotatable repeatable opening and closing of soft tissue clamps (referred to as harmony clips, Mico-Tech, ROCC-D-26-195) should be applied to extend the bile duct axially, linear clamp the incised duodenal papilla, taking care to avoid clamping the bile duct stent, and removing the bile duct stent 3 weeks after ECPP. | Procedure or surgery | ECPP in common bile duct stones |
Primary outcome
Recurrent bile duct stones
Time frame: 12 months after ERCP
The patient developed a recurrence of common bile duct stones within 1 year after surgery. Signs of recurrent bile duct stones include symptoms of cholangitis such as abdominal pain, fever, jaundice, or re-elevation of direct bilirubin/GGT/ALP or simple imaging of common bile duct stones.
1 secondary outcome
Death or adverse events
Time frame: 12 months after ERCP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Background: PubMed 19691764Kageoka M, Watanabe F, Maruyama Y, Nagata K, Ohata A, Noda Y, Miwa I, Ikeya K. Long-term prognosis of patients after endoscopic sphincterotomy for choledocholithiasis. Dig Endosc. 2009 Jul;21(3):170-5. doi: 10.1111/j.1443-1661.2009.00880.x.
- Background: PubMed 29544453Nzenza TC, Al-Habbal Y, Guerra GR, Manolas S, Yong T, McQuillan T. Recurrent common bile duct stones as a late complication of endoscopic sphincterotomy. BMC Gastroenterol. 2018 Mar 15;18(1):39. doi: 10.1186/s12876-018-0765-3.
- Background: PubMed 9831833Tanaka M, Takahata S, Konomi H, Matsunaga H, Yokohata K, Takeda T, Utsunomiya N, Ikeda S. Long-term consequence of endoscopic sphincterotomy for bile duct stones. Gastrointest Endosc. 1998 Nov;48(5):465-9. doi: 10.1016/s0016-5107(98)70086-0.
- Background: PubMed 25874514Yang J, Jin H, Gu W, Zhang X, Zhang X. Determinants of long-term complications of endoscopic sphincterotomy are infections and high risk factors of bile duct and not sphincter of Oddi dysfunction. Eur J Gastroenterol Hepatol. 2015 Apr;27(4):412-8. doi: 10.1097/MEG.0000000000000295.
- Background: PubMed 11932781Costamagna G, Tringali A, Shah SK, Mutignani M, Zuccala G, Perri V. Long-term follow-up of patients after endoscopic sphincterotomy for choledocholithiasis, and risk factors for recurrence. Endoscopy. 2002 Apr;34(4):273-9. doi: 10.1055/s-2002-23632.
- Background: PubMed 12425545Sugiyama M, Atomi Y. Risk factors predictive of late complications after endoscopic sphincterotomy for bile duct stones: long-term (more than 10 years) follow-up study. Am J Gastroenterol. 2002 Nov;97(11):2763-7. doi: 10.1111/j.1572-0241.2002.07019.x.
- Background: PubMed 18477806Mortensen FV, Jepsen P, Tarone RE, Funch-Jensen P, Jensen LS, Sorensen HT. Endoscopic sphincterotomy and long-term risk of cholangiocarcinoma: a population-based follow-up study. J Natl Cancer Inst. 2008 May 21;100(10):745-50. doi: 10.1093/jnci/djn102. Epub 2008 May 13.
- Background: PubMed 18585972Stromberg C, Luo J, Enochsson L, Arnelo U, Nilsson M. Endoscopic sphincterotomy and risk of malignancy in the bile ducts, liver, and pancreas. Clin Gastroenterol Hepatol. 2008 Sep;6(9):1049-53. doi: 10.1016/j.cgh.2008.04.016. Epub 2008 Jun 30.
- Background: PubMed 28194398Afghani E, Lo SK, Covington PS, Cash BD, Pandol SJ. Sphincter of Oddi Function and Risk Factors for Dysfunction. Front Nutr. 2017 Jan 30;4:1. doi: 10.3389/fnut.2017.00001. eCollection 2017.
- Background: PubMed 17405290Mandryka Y, Klimczak J, Duszewski M, Kondras M, Modzelewski B. [Bile duct infections as a late complication after endoscopic sphincterotomy]. Pol Merkur Lekarski. 2006 Dec;21(126):525-7. Polish.
- Background: PubMed 20869711Yasuda I, Fujita N, Maguchi H, Hasebe O, Igarashi Y, Murakami A, Mukai H, Fujii T, Yamao K, Maeshiro K, Tada T, Tsujino T, Komatsu Y. Long-term outcomes after endoscopic sphincterotomy versus endoscopic papillary balloon dilation for bile duct stones. Gastrointest Endosc. 2010 Dec;72(6):1185-91. doi: 10.1016/j.gie.2010.07.006. Epub 2010 Sep 25.
- Background: PubMed 32929751Wang Y, Chang H, Zhang Y, Wang K, Zhang H, Yan X, Meng L, Yao W, Li K, Huang Y. Endoscopic endoclip papilloplasty preserves sphincter of oddi function. Eur J Clin Invest. 2021 Mar;51(3):e13408. doi: 10.1111/eci.13408. Epub 2020 Sep 22.
- 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.
Yonghui Huang, archiater principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EST and ECPP in people with Sphincterotomy, Endoscopic, run by Peking University Third 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 11 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yonghui Huang, archiater (13911765322, xuxiao_1028@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent bile duct stones (time frame: 12 months after 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 NCT05896280, which also lists 12 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 11 Jul 2023.