CholedocholithiasisNCT05638789
Endoscopic Sphincterotomy With Balloon Dilatation Versus Sphincterotomy Alone For Common Bile Duct Stones Removal
A study testing endoscopic sphincterotomy (EST) versus EST plus endoscopic papillary large balloon dilatation (EPLBD) in people with Choledocholithiasis, run by Hospital Universiti Sains Malaysia at 1 site in Malaysia.
Trial summary
Gallstone is a worldwide clinical problem which affecting most of the populations with incidence of 15 to 20% in west and 10% in Asians. About 5 to 15% of patient with gallstone will go on to develop bile duct calculi. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Choledocholithiasis
- What is being tested?
- endoscopic sphincterotomy (EST) versus EST plus endoscopic papillary large balloon dilatation (EPLBD)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteMalaysia
- Study dates
- 28 Jun 2021to 27 Jun 2022
- 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
- Patient's age 18 and above
- Patient with CBD stone documented on imaging studies
Who cannot join
- CBD stone size more than 15mm
- CBD stone number more than 3
- Concurrent hepatobiliary tumour
- Intrahepatic stone
- Bleeding tendencies: coagulopathy, thrombocytopenia, patient on anticoagulant medication
- Patient in sepsis/ Cholangitis patient
- Patient with acute pancreatitis
- Prior history of Bilroth II or Roux-en-y surgery
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Department of Surgery School of Medical Sciences, Universiti Sains Malaysia
Kubang Kerian, Kelantan, 16150
About this study
Gallstone is a worldwide clinical problem which affecting most of the populations with incidence of 15 to 20% in west and 10% in Asians. About 5 to 15% of patient with gallstone will go on to develop bile duct calculi. There are several endoscopic strategies developed for treatment of common bile duct stone such as endoscopic sphincterotomy (EST), endoscopic papillary large balloon dilatation (EPLBD) and combination of EST plus EPLBD. Our aim of this study is to compare efficacy, and safety of EST alone group versus EST plus EPLBD group in removing CBD stone.
Read the detailed description
Endoscopic sphincterotomy (EST) is most widely used during endoscopic retrograde cholangiopancreatography (ERCP) to remove common bile duct (CBD) stone and considered as standard therapy for treatment of choledocholithiasis. However, in view of EST requires an adequate incision on major duodenal papilla to achieve biliary cannulation, it can potentially cause damage to biliary sphincter during the procedure and potentially increased risk of some complications such as bleeding and biliary reflux. This procedure carries risk of complications such as haemorrhage, perforation, and long-term effect like sphincter dysfunction.
Staritz introduced a method called endoscopic papillary large balloon dilatation (EPLBD) in 1983 as an alternative to EST in clearing CBD stone. EPLBD can reduced the risk of bleeding and perforation post procedure, but it carries higher risk of post-ERCP pancreatitis.
About 10 to 15% of CBD stone are unable to be extracted by both EST or EPLBD alone, especially in those patients with big and difficult stone (size bigger than 10 to 15mm, numerous, barrel-shaped, and impacted stones). Besides that, other factors that can contribute to failure of stone extraction are periampullary diverticulum or post operative variation, tortuosity and tightening of distal common bile duct.
In 2003, Ersoz introduced combination of EST plus EPLBD as an alternative method. It can reduce the risk of complications through avoiding a complete sphincterotomy, shortening procedural time, and reducing the need of usage of mechanical lithotripsy.
In a study on 2007, it showed that EST plus EPLBD had comparable efficacy and safety when compared to conventional EST alone and both groups have similar complication rate. Besides that, in a recent study in 2020, it also showed that EST plus EPLBD had a comparable efficacy when compared with EST alone in clearing CBD stone and EST plus EPLBD required shorter procedural time when compared with EST alone. There is no significant increased risk in pancreatitis for EST plus EPLBD. While, in a randomized controlled study in 2017, it showed that EST plus EPLBD is more effective than EST alone in clearing large CBD stone and is equally safe compared to EST alone. In another randomized controlled trial in 2013, the study showed that the success rate for complete CBD stone removal in first session is higher in EST plus EPLBD group when compared to EST alone and it is statistically significant. But the overall stone clearance rate and complication rate was similar in both groups. Apart from that, there are many other studies have suggested EST plus EPBD as a safe and promising alternative to conventional EST or EPLBD. In a published meta-analysis, accumulated data showed that EST plus EPLBD is a safe and effective procedure in removing large or difficult CBD stone without any additional risk of complications.
There is still no definite conclusion in evaluating superiority of EST plus EPLBD vs EST alone in term of efficacy in removing CBD stone.
- Conditions
- Choledocholithiasis
- Being tested
- endoscopic sphincterotomy (EST) versus EST plus endoscopic papillary large balloon dilatation (EPLBD)
- Keywords
- endoscopic sphincterotomy (EST), endoscopic papillary large balloon dilatation (EPLBD)
- Medical subject headings
- Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic sphincterotomy (EST) versus EST plus endoscopic papillary large balloon dilatation (EPLBD)Procedure or surgery
EST alone vs EST plus EPLBD in removing common bile duct stone
| Study group | Role | What they receive |
|---|---|---|
| EST alone | Active comparator | Not described Receives: Procedure: endoscopic sphincterotomy (EST) versus EST plus endoscopic papillary large balloon dilatation (EPLBD) |
| EST + EPLBD | Active comparator | Not described Receives: Procedure: endoscopic sphincterotomy (EST) versus EST plus endoscopic papillary large balloon dilatation (EPLBD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete common bile stone clearance of EST alone versus EST plus EPLBD
to compare the rate of overall complete stone clearance in EST alone arm vs EST plus EPLBD arm
Measured: 12 months
Complication rate of EST alone versus EST plus EPLBD in removing CBD stone
to compare complication rate which are post ERCP bleeding, post-ERCP pancreatitis, perforation and cholangitis rate of EST alone arm versus EST plus EPLBD arm in removing CBD stone
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start28 Jun 2021
- Primary completion27 Jun 2022
- Study completion27 Jun 2022
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 CholedocholithiasisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- EST alone versus EST + EPLBD group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, OOI JIE SOANG, Hospital Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638789
- Sponsor's protocol ID
- HUSM
- Status last verified
- Nov 2022
- First submitted
- 24 Oct 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. doi: 10.1016/s0016-5107(91)70740-2.
PubMed 2070995Suissa A, Yassin K, Lavy A, Lachter J, Chermech I, Karban A, Tamir A, Eliakim R. Outcome and early complications of ERCP: a prospective single center study. Hepatogastroenterology. 2005 Mar-Apr;52(62):352-5.
PubMed 15816433Staritz M, Ewe K, Goerg K, Meyer zum Buschenfelde KH. Endoscopic balloon tamponade for conservative management of severe hemorrhage following endoscopic sphincterotomy. Z Gastroenterol. 1984 Nov;22(11):644-6.
PubMed 6516498Andriulli A, Loperfido S, Napolitano G, Niro G, Valvano MR, Spirito F, Pilotto A, Forlano R. Incidence rates of post-ERCP complications: a systematic survey of prospective studies. Am J Gastroenterol. 2007 Aug;102(8):1781-8. doi: 10.1111/j.1572-0241.2007.01279.x. Epub 2007 May 17.
PubMed 17509029Fu BQ, Xu YP, Tao LS, Yao J, Zhou CS. Endoscopic papillary balloon intermittent dilatation and endoscopic sphincterotomy for bile duct stones. World J Gastroenterol. 2013 Apr 21;19(15):2425-32. doi: 10.3748/wjg.v19.i15.2425.
PubMed 23613639Shim CS, Kim JW, Lee TY, Cheon YK. Is endoscopic papillary large balloon dilation safe for treating large CBD stones? Saudi J Gastroenterol. 2016 Jul-Aug;22(4):251-9. doi: 10.4103/1319-3767.187599.
PubMed 27488319Attam R, Freeman ML. Endoscopic papillary large balloon dilation for large common bile duct stones. J Hepatobiliary Pancreat Surg. 2009;16(5):618-23. doi: 10.1007/s00534-009-0134-2. Epub 2009 Jun 24.
PubMed 19551331
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Sphincterotomy With Balloon Dilatation Versus Sphincterotomy Alone For Common Bile Duct Stones Removal
- ClinicalTrials.gov ID
- NCT05638789
- Acronym / sponsor ID
- HUSM
- Conditions
- Choledocholithiasis
- Keywords
- endoscopic sphincterotomy (EST), endoscopic papillary large balloon dilatation (EPLBD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Hospital Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 27 Jun 2022 (actual)
- Study completion
- 27 Jun 2022 (actual)
- First posted
- 6 Dec 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.
Gallstone is a worldwide clinical problem which affecting most of the populations with incidence of 15 to 20% in west and 10% in Asians. About 5 to 15% of patient with gallstone will go on to develop bile duct calculi. There are several endoscopic strategies developed for treatment of common bile duct stone such as endoscopic sphincterotomy (EST), endoscopic papillary large balloon dilatation (EPLBD) and combination of EST plus EPLBD. Our aim of this study is to compare efficacy, and safety of EST alone group versus EST plus EPLBD group in removing CBD stone.
Detailed description
Endoscopic sphincterotomy (EST) is most widely used during endoscopic retrograde cholangiopancreatography (ERCP) to remove common bile duct (CBD) stone and considered as standard therapy for treatment of choledocholithiasis. However, in view of EST requires an adequate incision on major duodenal papilla to achieve biliary cannulation, it can potentially cause damage to biliary sphincter during the procedure and potentially increased risk of some complications such as bleeding and biliary reflux. This procedure carries risk of complications such as haemorrhage, perforation, and long-term effect like sphincter dysfunction.
Staritz introduced a method called endoscopic papillary large balloon dilatation (EPLBD) in 1983 as an alternative to EST in clearing CBD stone. EPLBD can reduced the risk of bleeding and perforation post procedure, but it carries higher risk of post-ERCP pancreatitis.
About 10 to 15% of CBD stone are unable to be extracted by both EST or EPLBD alone, especially in those patients with big and difficult stone (size bigger than 10 to 15mm, numerous, barrel-shaped, and impacted stones). Besides that, other factors that can contribute to failure of stone extraction are periampullary diverticulum or post operative variation, tortuosity and tightening of distal common bile duct.
In 2003, Ersoz introduced combination of EST plus EPLBD as an alternative method. It can reduce the risk of complications through avoiding a complete sphincterotomy, shortening procedural time, and reducing the need of usage of mechanical lithotripsy.
In a study on 2007, it showed that EST plus EPLBD had comparable efficacy and safety when compared to conventional EST alone and both groups have similar complication rate. Besides that, in a recent study in 2020, it also showed that EST plus EPLBD had a comparable efficacy when compared with EST alone in clearing CBD stone and EST plus EPLBD required shorter procedural time when compared with EST alone. There is no significant increased risk in pancreatitis for EST plus EPLBD. While, in a randomized controlled study in 2017, it showed that EST plus EPLBD is more effective than EST alone in clearing large CBD stone and is equally safe compared to EST alone. In another randomized controlled trial in 2013, the study showed that the success rate for complete CBD stone removal in first session is higher in EST plus EPLBD group when compared to EST alone and it is statistically significant. But the overall stone clearance rate and complication rate was similar in both groups. Apart from that, there are many other studies have suggested EST plus EPBD as a safe and promising alternative to conventional EST or EPLBD. In a published meta-analysis, accumulated data showed that EST plus EPLBD is a safe and effective procedure in removing large or difficult CBD stone without any additional risk of complications.
There is still no definite conclusion in evaluating superiority of EST plus EPLBD vs EST alone in term of efficacy in removing CBD stone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- EST alone versus EST + EPLBD group
| Arm | Type | Receives |
|---|---|---|
| EST alone | Active comparator | Procedure: endoscopic sphincterotomy (EST) versus EST plus endoscopic papillary large balloon dilatation (EPLBD) |
| EST + EPLBD | Active comparator | Procedure: endoscopic sphincterotomy (EST) versus EST plus endoscopic papillary large balloon dilatation (EPLBD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient's age 18 and above
- Patient with CBD stone documented on imaging studies
Key exclusion criteria (8 listed)
- CBD stone size more than 15mm
- CBD stone number more than 3
- Concurrent hepatobiliary tumour
- Intrahepatic stone
- Bleeding tendencies: coagulopathy, thrombocytopenia, patient on anticoagulant medication
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 |
|---|---|---|
| endoscopic sphincterotomy (EST) versus EST plus endoscopic papillary large balloon dilatation (EPLBD)EST alone vs EST plus EPLBD in removing common bile duct stone | Procedure or surgery | EST + EPLBD, EST alone |
Primary outcome
Rate of complete common bile stone clearance of EST alone versus EST plus EPLBD
Time frame: 12 months
to compare the rate of overall complete stone clearance in EST alone arm vs EST plus EPLBD arm
Complication rate of EST alone versus EST plus EPLBD in removing CBD stone
Time frame: 12 months
to compare complication rate which are post ERCP bleeding, post-ERCP pancreatitis, perforation and cholangitis rate of EST alone arm versus EST plus EPLBD arm in removing CBD stone
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 6 Dec 2022.
- Results publication: PubMed 2070995Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. doi: 10.1016/s0016-5107(91)70740-2.
- Results publication: PubMed 15816433Suissa A, Yassin K, Lavy A, Lachter J, Chermech I, Karban A, Tamir A, Eliakim R. Outcome and early complications of ERCP: a prospective single center study. Hepatogastroenterology. 2005 Mar-Apr;52(62):352-5.
- Results publication: PubMed 6516498Staritz M, Ewe K, Goerg K, Meyer zum Buschenfelde KH. Endoscopic balloon tamponade for conservative management of severe hemorrhage following endoscopic sphincterotomy. Z Gastroenterol. 1984 Nov;22(11):644-6.
- Results publication: PubMed 17509029Andriulli A, Loperfido S, Napolitano G, Niro G, Valvano MR, Spirito F, Pilotto A, Forlano R. Incidence rates of post-ERCP complications: a systematic survey of prospective studies. Am J Gastroenterol. 2007 Aug;102(8):1781-8. doi: 10.1111/j.1572-0241.2007.01279.x. Epub 2007 May 17.
- Results publication: PubMed 23613639Fu BQ, Xu YP, Tao LS, Yao J, Zhou CS. Endoscopic papillary balloon intermittent dilatation and endoscopic sphincterotomy for bile duct stones. World J Gastroenterol. 2013 Apr 21;19(15):2425-32. doi: 10.3748/wjg.v19.i15.2425.
- Results publication: PubMed 27488319Shim CS, Kim JW, Lee TY, Cheon YK. Is endoscopic papillary large balloon dilation safe for treating large CBD stones? Saudi J Gastroenterol. 2016 Jul-Aug;22(4):251-9. doi: 10.4103/1319-3767.187599.
- Results publication: PubMed 19551331Attam R, Freeman ML. Endoscopic papillary large balloon dilation for large common bile duct stones. J Hepatobiliary Pancreat Surg. 2009;16(5):618-23. doi: 10.1007/s00534-009-0134-2. Epub 2009 Jun 24.
- Individual participant dataSharing planned: Undecided
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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 endoscopic sphincterotomy (EST) versus EST plus endoscopic papillary large balloon dilatation (EPLBD) in people with Choledocholithiasis, run by Hospital Universiti Sains Malaysia at 1 site in Malaysia.
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 2 inclusion and 8 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 6 Dec 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 Malaysia. 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?
Rate of complete common bile stone clearance of EST alone versus EST plus EPLBD (time frame: 12 months). 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?
On the ClinicalTrials.gov record for NCT05638789, 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 6 Dec 2022.