Clinical trial NCT05746832: Failed Retrograde Cholangiopancreatography (ERCP) Stone Extraction: Surgical Interference
Official title: Failed Retrograde Cholangiopancreatography (ERCP) Stone Extraction: Surgical Interference Versus Follow up on Stent.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Common Bile Duct Calculi
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 3
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assessment of the differences in stone size and the largest CBD diameter before and after stenting in one or two sessions. Stone clearance and complications were also determined with the ERCP, and factors associated with complete clearance were evaluated in patients with difficult CBD stones (a large \[≥ 20 mm\] or multiple \[≥ 3 sized ≥ 15 mm\] CBD stones). And also compared the outcomes with conventional procedure of open surgery.

Detailed description: Gallstones are a very common problem in developed countries. Most patients with gallstones remain asymptomatic throughout their lifetime, but 10 % - 25 % of them may develop biliary pain or complications, with an annual risk of about 2 % - 3 % for symptomatic disease and 1 % - 2 % for major complications. The development of symptomatic disease and complications is mostly related to the migration of stones into the common bile duct (CBD). Common bile duct stones (CBDSs) may be treated by endoscopic retrograde cholangiopancreatography (ERCP) or surgically during cholecystectomy. Removal of common bile duct (CBD) stones can still be difficult in patients with large or multiple stones despite an adequate sphincterotomy. Procedures such as mechanical, extracorporeal, electrohydraulic or laser lithotripsy, and chemical dissolution have been introduced as effective therapeutic interventions for irretrievable CBD stones. However, these techniques have their drawbacks, are not widely available, or are still under clinical evaluation. Several studies have shown that insertion of an endoscopic biliary stent is a safe, effective, and widely available measure. An indwelling stent provides biliary drainage and fragments large stones, thereby reducing the risk of cholangitis and allowing stones to pass spontaneously or rendering them more extractable at a later procedure. Thus, this study intends to shed a light on advances in diagnosis and management in patients with biliary difficult stones.

Eligibility criteria: Inclusion Criteria:

1. All cases of difficult common bile duct stones leading to variable occlusion.
2. Patients fit for intervention.
3. Patients informed consent for study.

Exclusion Criteria:

1. Surgically unfit cases according to ASA
2. Locally advanced irresectable cases.
3. Patients refuse consent to participate in the study.

Primary outcomes:
measure: Time of procedure.
timeFrame: On the day of determined procedure.
measure: Rate of stone size reduction.
timeFrame: Baseline.
measure: Width of CBD.
timeFrame: Baseline.
measure: Degree of stone clearance and complications.
timeFrame: Baseline.
measure: Postoperative morbidity and mortality.
timeFrame: Baseline.
Secondary outcomes:
measure: Blood loss during the procedure.
timeFrame: Baseline.
measure: Postoperative wound infection.
timeFrame: Baseline.
measure: Postoperative hospital stay.
timeFrame: Baseline.
measure: Postoperative hemorrhage.
timeFrame: Baseline.
measure: Postoperative 30 day mortality rate.
timeFrame: Baseline.
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut universty Hospital
Study officials:
affiliation: Assiut University
name: Hisham Ali Ryad, Prof.
role: PRINCIPAL_INVESTIGATOR
References: