Actively Recruiting

Age: 18Years +
All Genders
NCT07413068

Treatment Outcomes and Complications of Three Therapeutic Approaches for Concomitant Choledocholithiasis and Cholecystolithiasis

Led by Qilu Hospital of Shandong University · Updated on 2026-02-17

300

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

Sponsors

Q

Qilu Hospital of Shandong University

Lead Sponsor

T

The Affiliated Hospital of Qingdao University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Recruit patients with cholelithiasis with concomitant choledocholithiasis into the cohort, and assign them to undergo endoscopic transpapillary gallbladder-preserving cholecystolithotomy or ERCP plus laparoscopic cholecystectomy or conservative treatment based on patient preference. Collect clinical data and patient-reported outcomes regularly at baseline and during follow-up in the cohort. Assess the clinical safety of ERCP-GPC and LC by evaluating the clinical success rate of treatment as well as the incidence of short-term and long-term postoperative complications; investigate the efficacy differences among endoscopic transpapillary gallbladder-preserving cholecystolithotomy or ERCP plus laparoscopic cholecystectomy or conservative treatment in managing cholelithiasis with concomitant choledocholithiasis.

CONDITIONS

Official Title

Treatment Outcomes and Complications of Three Therapeutic Approaches for Concomitant Choledocholithiasis and Cholecystolithiasis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over the age of 18 years
  • Diagnosis of cholelithiasis with choledocholithiasis confirmed by ultrasound, MRCP, CT, or MRI
  • No history of gastrointestinal reconstruction surgery, cholecystectomy, or previous biliary tract surgery including ERCP
  • Gallbladder stones are 1 cm in diameter or smaller, or sludge-like stones
  • Gallbladder shape and size are normal, with wall thickness 3 mm or less
  • Signed informed consent is provided voluntarily
Not Eligible

You will not qualify if you...

  • Atrophic cholecystitis, porcelain gallbladder, suspected gallbladder cancer, lower common bile duct stenosis, or Mirrizzi syndrome
  • Unable to undergo endoscopic interventions
  • Absolute surgical contraindications such as severe liver, kidney, heart, or lung failure, history of cerebral coma, or allergy to anesthesia
  • Ectopic duodenal papilla or congenital pancreaticobiliary malformation
  • Severe coagulopathy with INR greater than 1.5 or platelet count less than 50 x 10⁹/L
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Qilu Hospital of Shandong University

Jinan, Shandong, China, 250063

Actively Recruiting

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Research Team

Z

Zhen Li, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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