Effect of ECPP on Recurrent Bile Duct Stones

July 9, 2023 updated by: Peking University Third Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100101
        • Recruiting
        • Peking University Third Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months after ERCP

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Principal Investigator: Yonghui Huang, archiater, Peking University Third Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Estimated)

August 1, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

May 31, 2023

First Submitted That Met QC Criteria

May 31, 2023

First Posted (Actual)

June 9, 2023

Study Record Updates

Last Update Posted (Actual)

July 11, 2023

Last Update Submitted That Met QC Criteria

July 9, 2023

Last Verified

October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • LM2023425

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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