Effect of ECPP on Recurrent Bile Duct Stones

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Endoclip Papilloplasty and Relationship Between Post-operative Microecological Environment and Recurrent Bile Duct Stones

Conditions
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Sphincterotomy, Endoscopic

Intervention / Treatment
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* Procedure: EST
* Procedure: ECPP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EST in common bile duct stones<br>With routine EST surgery, the sphincter is cut open and stones are removed | Procedure: EST<br>* Stones are taken by cutting the papillary sphincter<br>|
| Experimental: ECPP in common bile duct stones<br>Common bile duct stones are removed after EST, and then ECPP is performed. | Procedure: EST<br>* Stones are taken by cutting the papillary sphincter<br>Procedure: ECPP<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months after ERCP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death or adverse events | The patient dies or develops postoperative complications of ERCP, stent displacement, detachment, etc., failure of ERCP. | 12 months after ERCP |