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Effect of ECPP on Recurrent Bile Duct Stones

NCT05896280 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2023-07-11

No results posted yet for this study

Summary

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.

Conditions

  • Sphincterotomy, Endoscopic

Interventions

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.

Sponsors & Collaborators

  • Peking University Third Hospital

    lead OTHER

Principal Investigators

  • Yonghui Huang, archiater · Peking University Third Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2023-08-01
Completion
2023-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05896280 on ClinicalTrials.gov