Sphincter of Oddi FunctionNCT04183036
Endoclip Papillaplasty Recover Sphincter of Oddi Function After Endoscopic Sphincterotomy for Bile Duct Gallstones
A study testing Endoclip papillaplasty in people with Sphincter of Oddi Function, run by Peking University Third Hospital at 1 site in China.
Trial summary
Gallstones in the common bile duct (CBD) may be asymptomatic but may lead to complications such as acute cholangitis or acute pancreatitis. EST is widely used for the treatment of bile duct gallstones. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sphincter of Oddi Function
- What is being tested?
- Endoclip papillaplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 1 Aug 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1)18-85 years of age; 2) informed consent obtained before ERCP; 3) CBD diameter ≥12 mm; 4) CBD gallstones visualized at magnetic resonance cholangiopancreatography (MRCP) with at least one gallstone ≥10 mm (transverse diameter)
Who cannot join
- gallstone transverse diameter >35 mm, which is not appropriate to be extracted;
- history of previous sphincterotomy, previous EPBD;
- accompanied with choledochoduodenal fistula, coagulopathy, anticoagulant/antiplatelet therapy, or Billroth II or Roux-en-Y reconstruction;
- papilla located deep within a diverticulum;
- small papilla and short intramural segment, which was not suitable for large EST;
- medications known to affect the SO (calcium channel blockers, nitrates, opiates, and anticholinergics) taken within 48 h of the procedure;
- benign or malignant biliary stricture.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiue yan
Beijing, Beijing Municipality, 86-100191
Xiue yan, archiater, 15811117418, pskyq@163.com
About this study
Official title: Endoscopic Sphincterotomy (EST) for Bile Duct Gallstones Cause Damage to the Ampulla of Vater and Sphincter of Oddi (SO): Endoclip Papillaplasty Help Recover the Damaged SO Function and Possibly Prevent Gallstone Recurrence
Gallstones in the common bile duct (CBD) may be asymptomatic but may lead to complications such as acute cholangitis or acute pancreatitis. EST is widely used for the treatment of bile duct gallstones. Despite its efficacy and improvements over time, EST is still associated with complications such as hemorrhage, perforation, pancreatitis, and permanent loss of function of the sphincter of Oddi (SO). Permanent loss of SO function can cause duodenobiliary reflux, bacterial colonization of the biliary tract, gallstone recurrence, cholangitis, and liver abscess.
Endoscopic papillary balloon dilation (EPBD) was first proposed in 1983 and it is now recognized as an alternative technique for the removal of CBD gallstones. The small balloon (diameter <8 mm) is less invasive, reduces the occurrence of adverse effects, and preserves the SO function, but it has limitations in the presence of CBD gallstones ≥10 mm in diameter. EST combined with endoscopic papillary large-balloon dilation (EPLBD) has been introduced for patients with large gallstone, but EPLBD widens the distal common bile duct and still may cause SO function damage, partially or completely. Repairing the ampulla of Vater and SO may reduce the long-term complication rates, especially gallstone recurrence. Unfortunately, no efficient strategy has been proposed. The present pilot study aimed to examine the feasibility and efficiency of an innovative strategy named endoclip papilloplasty to repair the damaged ampulla and recover SO function. The advantage of this device is that it can be rotated clockwise or counterclockwise by turning the handle until the correct position is achieved. Another advantage is if the clip is not in desired position, it may be re-opened and repositioned. Once satisfying clip positioning is achieved, the clip can be firmly attached to the tissue by pulling the slider back until tactile resistance is felt in the handle.Briefly, the operator assessed the patulous biliary opening and ductal axis, positioned and adjusted eachendoclip in order to close the patulous opening
Read the detailed description
In order to reduce PEP risk, a rectal non-steroidal anti-inflammatory drug was administered 30 minutes before the ERCP in all patients. As the standard of care at the study hospital, the patients swallowed 2% lidocaine hydrochloride gel for local pharyngeal anesthesia, and 10 mg of diazepam were injected intramuscularly before ERCP. Anti-convulsants were not allowed. ERCP was performed in a standard manner using a side-viewing endoscope.
After successful selective deep cannulation of the common bile duct with a guidewire, the guidewire was extracted, and SOM was performed before contrast agent was introduced to determine the margins of the choledocholithiasis.
EST was performed, and the size of EST, which was large incision (incision to the full part of the ampulla) or long enough to ensure successful stone extraction, depended on the transverse diameter of the stones.
After stones removal, a 7.5Fr×26 cm biliary plastic stent, which was a suspended overlong biliary stent formed from a nasobiliary drainage tube (Boston Scientific), was placed to ensure that the biliary duct would not be clipped during endoclip papillaplasty and to reduce duodenobiliary reflux during the next 3-week before follow-up.
The investigators will recruit patients according to admission criteria and exclusion criteria. The participants underwent SOM before, immediately after EST, and 3 weeks after EST with endoclip papilloplasty. The participants were followed for 3 days during hospitalized. Complications including perforation, bleeding, and PEP were recorded. Blood routine, pancreatic enzymes (amylase and lipase), and liver function (serum alanine aminotransferase, aspartate aminotransferase, r-glutamyl transpeptidase, and alkaline phosphatase) were tested at 4 and 24 h after ERCP. All participants were followed at 3 weeks. The stent will be romoved with Allis clamp 3 weeks after the procedure.Symptoms were examined and blood tests as above were repeated ahead of stents retrieval and sphincter of Oddi monitoring through duodenoscope.
- Conditions
- Sphincter of Oddi Function
- Being tested
- Endoclip papillaplasty
- Keywords
- Choledocholithiasis, sphincterotomy;sphincter of Oddi
- Medical subject headings
- Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoclip papillaplastyProcedure or surgery
Endoclip papilloplasty was performed to repair the Oddi sphincter using sterile repositionable hemostasis clipping device (Micro-tech (Nanjing), Co., Ltd.; stainless-steel). The operator positioned the clip and assessed the clip position and made sure the incision was clipped. Four to five endoclips were positioned in the incision in a zipper way from distal to proximal papillary sphincterotomy
| Study group | Role | What they receive |
|---|---|---|
| Small EST combined with EPLBD | No intervention | Not described |
| Large EST combined with ECPP | Experimental | Not described Receives: Procedure: Endoclip papillaplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
SO manometric change
The comparison of the SO manometric date before and after the procedure
Measured: Before operation, During operation, Three weeks after operation
Secondary outcomes (1)
Frequency of use of ML and the incidence of adverse events
Mearsure the frequency of ML and the incidence of adverse events ，and to evaluate the healing of the ampulla
Measured: Three weeks after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start1 May 2018
- Primary completion31 Mar 2019
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sphincter of Oddi FunctionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huang Yonghui, Peking University Third Hospital
- Investigators
- Yonghui Huang, MD, Principal investigator, Peking University Third Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183036
- Sponsor's protocol ID
- W201908
- Status last verified
- Nov 2019
- First submitted
- 18 Nov 2019
- Last updated
- 3 Dec 2019
- Results posted
- No
- 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 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Sphincterotomy (EST) for Bile Duct Gallstones Cause Damage to the Ampulla of Vater and Sphincter of Oddi (SO): Endoclip Papillaplasty Help Recover the Damaged SO Function and Possibly Prevent Gallstone Recurrence
- ClinicalTrials.gov ID
- NCT04183036
- Acronym / sponsor ID
- W201908
- Conditions
- Sphincter of Oddi Function
- Keywords
- Choledocholithiasis, sphincterotomy;sphincter of Oddi
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 3 Dec 2019 (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.
Gallstones in the common bile duct (CBD) may be asymptomatic but may lead to complications such as acute cholangitis or acute pancreatitis. EST is widely used for the treatment of bile duct gallstones. Despite its efficacy and improvements over time, EST is still associated with complications such as hemorrhage, perforation, pancreatitis, and permanent loss of function of the sphincter of Oddi (SO). Permanent loss of SO function can cause duodenobiliary reflux, bacterial colonization of the biliary tract, gallstone recurrence, cholangitis, and liver abscess.
Endoscopic papillary balloon dilation (EPBD) was first proposed in 1983 and it is now recognized as an alternative technique for the removal of CBD gallstones. The small balloon (diameter <8 mm) is less invasive, reduces the occurrence of adverse effects, and preserves the SO function, but it has limitations in the presence of CBD gallstones ≥10 mm in diameter. EST combined with endoscopic papillary large-balloon dilation (EPLBD) has been introduced for patients with large gallstone, but EPLBD widens the distal common bile duct and still may cause SO function damage, partially or completely. Repairing the ampulla of Vater and SO may reduce the long-term complication rates, especially gallstone recurrence. Unfortunately, no efficient strategy has been proposed. The present pilot study aimed to examine the feasibility and efficiency of an innovative strategy named endoclip papilloplasty to repair the damaged ampulla and recover SO function. The advantage of this device is that it can be rotated clockwise or counterclockwise by turning the handle until the correct position is achieved. Another advantage is if the clip is not in desired position, it may be re-opened and repositioned. Once satisfying clip positioning is achieved, the clip can be firmly attached to the tissue by pulling the slider back until tactile resistance is felt in the handle.Briefly, the operator assessed the patulous biliary opening and ductal axis, positioned and adjusted eachendoclip in order to close the patulous opening
Detailed description
In order to reduce PEP risk, a rectal non-steroidal anti-inflammatory drug was administered 30 minutes before the ERCP in all patients. As the standard of care at the study hospital, the patients swallowed 2% lidocaine hydrochloride gel for local pharyngeal anesthesia, and 10 mg of diazepam were injected intramuscularly before ERCP. Anti-convulsants were not allowed. ERCP was performed in a standard manner using a side-viewing endoscope.
After successful selective deep cannulation of the common bile duct with a guidewire, the guidewire was extracted, and SOM was performed before contrast agent was introduced to determine the margins of the choledocholithiasis.
EST was performed, and the size of EST, which was large incision (incision to the full part of the ampulla) or long enough to ensure successful stone extraction, depended on the transverse diameter of the stones.
After stones removal, a 7.5Fr×26 cm biliary plastic stent, which was a suspended overlong biliary stent formed from a nasobiliary drainage tube (Boston Scientific), was placed to ensure that the biliary duct would not be clipped during endoclip papillaplasty and to reduce duodenobiliary reflux during the next 3-week before follow-up.
The investigators will recruit patients according to admission criteria and exclusion criteria. The participants underwent SOM before, immediately after EST, and 3 weeks after EST with endoclip papilloplasty. The participants were followed for 3 days during hospitalized. Complications including perforation, bleeding, and PEP were recorded. Blood routine, pancreatic enzymes (amylase and lipase), and liver function (serum alanine aminotransferase, aspartate aminotransferase, r-glutamyl transpeptidase, and alkaline phosphatase) were tested at 4 and 24 h after ERCP. All participants were followed at 3 weeks. The stent will be romoved with Allis clamp 3 weeks after the procedure.Symptoms were examined and blood tests as above were repeated ahead of stents retrieval and sphincter of Oddi monitoring through duodenoscope.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Small EST combined with EPLBD | No intervention | – |
| Large EST combined with ECPP | Experimental | Procedure: Endoclip papillaplasty |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1)18-85 years of age; 2) informed consent obtained before ERCP; 3) CBD diameter ≥12 mm; 4) CBD gallstones visualized at magnetic resonance cholangiopancreatography (MRCP) with at least one gallstone ≥10 mm (transverse diameter)
Key exclusion criteria (7 listed)
- gallstone transverse diameter >35 mm, which is not appropriate to be extracted;
- history of previous sphincterotomy, previous EPBD;
- accompanied with choledochoduodenal fistula, coagulopathy, anticoagulant/antiplatelet therapy, or Billroth II or Roux-en-Y reconstruction;
- papilla located deep within a diverticulum;
- small papilla and short intramural segment, which was not suitable for large EST;
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 |
|---|---|---|
| Endoclip papillaplastyEndoclip papilloplasty was performed to repair the Oddi sphincter using sterile repositionable hemostasis clipping device (Micro-tech (Nanjing), Co., Ltd.; stainless-steel). The operator positioned the clip and assessed the clip position and made sure the incision was clipped. Four to five endoclips were positioned in the incision in a zipper way from distal to proximal papillary sphincterotomy | Procedure or surgery | Large EST combined with ECPP |
Primary outcome
SO manometric change
Time frame: Before operation, During operation, Three weeks after operation
The comparison of the SO manometric date before and after the procedure
1 secondary outcome
Frequency of use of ML and the incidence of adverse events
Time frame: Three weeks after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- Individual participant dataSharing planned: No
Related trials for Sphincter of Oddi Function
Recruiting
QST Study: Predicting Treatment Response in Chronic Pancreatitis Using Quantitative Sensory Testing
Chronic Pancreatitis, Chronic Pain
RecruitingObservational study
Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation (STRIDE)
Inflammatory Bowel Diseases, Crohn Disease
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, MD principal investigator
Peking University Third Hosptial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoclip papillaplasty in people with Sphincter of Oddi Function, 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 1 inclusion and 7 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 3 Dec 2019. 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, MD (86-10-13911765322, 13911765322@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SO manometric change (time frame: Before operation, During operation, Three weeks after operation). 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 3 Dec 2019.