Common Bile Duct Gall StonesNCT02329977
Rate of Duodenal-biliary Reflux Increases in Patients With Recurrent Common Bile Duct Stones
An observational study of Common Bile Duct Gall Stones and Common Bile Duct GallStones, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
ERCP is the primary choice for removal of common bile duct stone (CBDS) currently. However, 4-24% patients underwent recurrence after successful clearance of CBDS. Stone re-formation due to chronic inflammation of biliary duct is generally considered an important cause of CBDS recurrence, which is associated with… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Common Bile Duct Gall Stones, Common Bile Duct GallStones
- What is being tested?
- standard barium meal examination
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Jan 2014
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with history of recurrent common bile duct stone (recurrent group) and non-recurrent common bile duct stone (control group) in Xijing Hospital of Digestive Diseases were invited to participate the study. All the patients underwent successful stone removal by ERCP previously. Patients in the control group were matched with the recurrence group by age and gender at 1:1 ratio.
Who may be able to join
- Patients with common bile duct stone underwent successful stone removal by ERCP in Xijing Hospital of Digestive Diseases.
Who cannot join
- Gallbladder stones or hepatolithiasis;
- Stenosis of biliary duct;
- Incomplete common bile duct stone removal by ERCP;
- Common bile duct stent;
- Unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rate of Duodenal-biliary Reflux Increases in Patients With Recurrent Common Bile Duct Stones: Direct Evidence From Barium Meal Examination
ERCP is the primary choice for removal of common bile duct stone (CBDS) currently. However, 4-24% patients underwent recurrence after successful clearance of CBDS. Stone re-formation due to chronic inflammation of biliary duct is generally considered an important cause of CBDS recurrence, which is associated with duodenal-biliary reflux (DBR) after sphincterotomy. Although it was believed that DBR was the important cause of CBDS recurrence, the direct evidence was still lacking. Here we conducted a case control study to investigate the DBR rate in patients with recurrent CBDS after ERCP.
- Being tested
- standard barium meal examination
- Keywords
- duodenal-biliary reflux
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard barium meal examinationOther
All eligible patients received standard barium meal examination, MRCP and enhanced abdominal CT.
| Study group | Role | What they receive |
|---|---|---|
| Recurrent group | Patients with history of recurrent common bile duct stone after successfully ERCP stone remove. Receives: Other: standard barium meal examination | |
| Control group | Patients without history of recurrent common bile duct stone after successfully ERCP stone remove. Receives: Other: standard barium meal examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duodenal-biliary reflux rate
The proportion of patients with barium reflux into bile duct during the standard barium meal examination.
Measured: up to 6 months
Secondary outcomes (4)
Distal common bile duct angle
MRCP revealed the first angulation from the ampullary orifice along the course of the common bile duct stone.
Measured: up to 6 months
Maximal CBD diameter
Maximal CBD diameter was determined by MRCP.
Measured: up to 6 months
Peripapillary diverticulum
Peripapillary diverticulum was defined endoscopically as the presence of a diverticulum within a 2-cm radius from the papilla and was divided into 2 types in terms of the relation between the papilla and diverticulum: type A, papilla located on the inner rim of the diverticulum or papilla located deep within the diverticulum; and type B, papilla located outside the diverticulum.
Measured: up to 6 months
Pneumobilia
Pneumobilia were determined by CT
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2015 (estimated)
- Study startJun 2013
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Common Bile Duct Gall StonesStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanglin Pan, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329977
- Sponsor's protocol ID
- 20130508-2
- Status last verified
- Dec 2015
- First submitted
- 20 Dec 2014
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Keizman D, Ish Shalom M, Konikoff FM. Recurrent symptomatic common bile duct stones after endoscopic stone extraction in elderly patients. Gastrointest Endosc. 2006 Jul;64(1):60-5. doi: 10.1016/j.gie.2006.01.022.
PubMed 16813804Cheon YK, Lehman GA. Identification of risk factors for stone recurrence after endoscopic treatment of bile duct stones. Eur J Gastroenterol Hepatol. 2006 May;18(5):461-4. doi: 10.1097/00042737-200605000-00001.
PubMed 16607138Ishiguro J. Biliary bacteria as an indicator of the risk of recurrence of choledocholithiasis after endoscopic sphincterotomy. Diagn Ther Endosc. 1998;5(1):9-17. doi: 10.1155/DTE.5.9.
PubMed 18493475Kim DI, Kim MH, Lee SK, Seo DW, Choi WB, Lee SS, Park HJ, Joo YH, Yoo KS, Kim HJ, Min YI. Risk factors for recurrence of primary bile duct stones after endoscopic biliary sphincterotomy. Gastrointest Endosc. 2001 Jul;54(1):42-8. doi: 10.1067/mge.2001.115335.
PubMed 11427840Misra SP, Dwivedi M. Reflux of duodenal contents and cholangitis in patients undergoing self-expanding metal stent placement. Gastrointest Endosc. 2009 Aug;70(2):317-21. doi: 10.1016/j.gie.2008.12.054. Epub 2009 Jun 21.
PubMed 19539920Ando T, Tsuyuguchi T, Okugawa T, Saito M, Ishihara T, Yamaguchi T, Saisho H. Risk factors for recurrent bile duct stones after endoscopic papillotomy. Gut. 2003 Jan;52(1):116-21. doi: 10.1136/gut.52.1.116.
PubMed 12477771Zhang R, Luo H, Pan Y, Zhao L, Dong J, Liu Z, Wang X, Tao Q, Lu G, Guo X. Rate of duodenal-biliary reflux increases in patients with recurrent common bile duct stones: evidence from barium meal examination. Gastrointest Endosc. 2015 Oct;82(4):660-5. doi: 10.1016/j.gie.2015.03.1908. Epub 2015 May 5.
PubMed 25952091
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rate of Duodenal-biliary Reflux Increases in Patients With Recurrent Common Bile Duct Stones: Direct Evidence From Barium Meal Examination
- ClinicalTrials.gov ID
- NCT02329977
- Acronym / sponsor ID
- 20130508-2
- Keywords
- duodenal-biliary reflux
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 1 Jan 2015 (estimated)
- 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.
ERCP is the primary choice for removal of common bile duct stone (CBDS) currently. However, 4-24% patients underwent recurrence after successful clearance of CBDS. Stone re-formation due to chronic inflammation of biliary duct is generally considered an important cause of CBDS recurrence, which is associated with duodenal-biliary reflux (DBR) after sphincterotomy. Although it was believed that DBR was the important cause of CBDS recurrence, the direct evidence was still lacking. Here we conducted a case control study to investigate the DBR rate in patients with recurrent CBDS after ERCP.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recurrent group | – | Other: standard barium meal examinationPatients with history of recurrent common bile duct stone after successfully ERCP stone remove. |
| Control group | – | Other: standard barium meal examinationPatients without history of recurrent common bile duct stone after successfully ERCP stone remove. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with history of recurrent common bile duct stone (recurrent group) and non-recurrent common bile duct stone (control group) in Xijing Hospital of Digestive Diseases were invited to participate the study. All the patients underwent successful stone removal by ERCP previously. Patients in the control group were matched with the recurrence group by age and gender at 1:1 ratio.
Key inclusion criteria (1 listed)
- Patients with common bile duct stone underwent successful stone removal by ERCP in Xijing Hospital of Digestive Diseases.
Key exclusion criteria (5 listed)
- Gallbladder stones or hepatolithiasis;
- Stenosis of biliary duct;
- Incomplete common bile duct stone removal by ERCP;
- Common bile duct stent;
- Unable to provide informed consent.
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 |
|---|---|---|
| standard barium meal examinationAll eligible patients received standard barium meal examination, MRCP and enhanced abdominal CT. | Other | Control group, Recurrent group |
Primary outcome
Duodenal-biliary reflux rate
Time frame: up to 6 months
The proportion of patients with barium reflux into bile duct during the standard barium meal examination.
4 secondary outcomes
Distal common bile duct angle
Time frame: up to 6 months
Maximal CBD diameter
Time frame: up to 6 months
Peripapillary diverticulum
Time frame: up to 6 months
Pneumobilia
Time frame: up to 6 months
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 2 Dec 2015.
- Background: PubMed 16813804Keizman D, Ish Shalom M, Konikoff FM. Recurrent symptomatic common bile duct stones after endoscopic stone extraction in elderly patients. Gastrointest Endosc. 2006 Jul;64(1):60-5. doi: 10.1016/j.gie.2006.01.022.
- Background: PubMed 16607138Cheon YK, Lehman GA. Identification of risk factors for stone recurrence after endoscopic treatment of bile duct stones. Eur J Gastroenterol Hepatol. 2006 May;18(5):461-4. doi: 10.1097/00042737-200605000-00001.
- Background: PubMed 18493475Ishiguro J. Biliary bacteria as an indicator of the risk of recurrence of choledocholithiasis after endoscopic sphincterotomy. Diagn Ther Endosc. 1998;5(1):9-17. doi: 10.1155/DTE.5.9.
- Background: PubMed 11427840Kim DI, Kim MH, Lee SK, Seo DW, Choi WB, Lee SS, Park HJ, Joo YH, Yoo KS, Kim HJ, Min YI. Risk factors for recurrence of primary bile duct stones after endoscopic biliary sphincterotomy. Gastrointest Endosc. 2001 Jul;54(1):42-8. doi: 10.1067/mge.2001.115335.
- Background: PubMed 19539920Misra SP, Dwivedi M. Reflux of duodenal contents and cholangitis in patients undergoing self-expanding metal stent placement. Gastrointest Endosc. 2009 Aug;70(2):317-21. doi: 10.1016/j.gie.2008.12.054. Epub 2009 Jun 21.
- Background: PubMed 12477771Ando T, Tsuyuguchi T, Okugawa T, Saito M, Ishihara T, Yamaguchi T, Saisho H. Risk factors for recurrent bile duct stones after endoscopic papillotomy. Gut. 2003 Jan;52(1):116-21. doi: 10.1136/gut.52.1.116.
- Derived from this study: PubMed 25952091Zhang R, Luo H, Pan Y, Zhao L, Dong J, Liu Z, Wang X, Tao Q, Lu G, Guo X. Rate of duodenal-biliary reflux increases in patients with recurrent common bile duct stones: evidence from barium meal examination. Gastrointest Endosc. 2015 Oct;82(4):660-5. doi: 10.1016/j.gie.2015.03.1908. Epub 2015 May 5.
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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?
An observational study of Common Bile Duct Gall Stones and Common Bile Duct GallStones, run by Air Force Military Medical University, China 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 1 inclusion and 5 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 2 Dec 2015. 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?
Duodenal-biliary reflux rate (time frame: up to 6 months). 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 NCT02329977, which also lists 7 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 2 Dec 2015.