Comparison of Endoscopic Sphincterotomy Plus Large-balloon Dilatation and Conventional Treatment for Large CBD Stones

Choledocholithiasis Clinical Trial

Official title:

Endoscopic Sphincterotomy Plus Large-Balloon Dilatation (ESLBD) Versus Conventional Endoscopic Treatment for Removal of Large Common Bile Duct Stones : A Prospective Comparative Multi Center Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02592811
• Other study ID #: SocieteFranceED
• Status: Completed
• Phase: Phase 3
• First received: October 5, 2015
• Last updated: October 28, 2015
• Start date: July 2010
• Est. completion date: March 2015

Study information

• Verified date: October 2015
• Source: Société Française d'Endoscopie Digestive
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial Summary

Bile duct stone extraction is impossible after endoscopic sphincterotomy (ES) alone in approximatively 10% of cases (mostly because of stones' size). Adjunction of a mechanical lithotripsy (ML) is well established to improve clearance of common bile duct (CBD) stones. Because of inconstant success, high cost, and length of procedure, an alternative method was proposed in 2003: endoscopic sphincterotomy plus large balloon dilatation (ESLBD). If the safety of ESLBD is accepted in all recent published studies, it remains controversial wether ESLBD is superior to conventional endoscopic treatment associating ES± ML for CBD stones. Procedure treatment and place of ESLBD in CBD stones therapeutic strategy is unclear.

The purpose of this prospective comparative multi center randomized study is to evaluate the superiority or not of ESLBD on conventional treatment (ES±ML) for the treatment of large bile duct stone (≥13mm) after standard ES, and to propose a new CBD stones therapeutic strategy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with CBD stones with a smaller diameter = 13mm on cholangiogram

Exclusion Criteria:

• Active or history of acute pancreatitis

• Presence of intrahepatic stones

• History of Billroth II or roux-en-Y reconstruction

• Coagulation disorder (partial thromboplastin time > 42 seconds, prothrombin time (Quick value) < 50% and platelet count of <50 000/mm3)

• Current anticoagulation or clopidogrel treatment

• Pregnancy

• Inability to give informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choledocholithiasis
• Gallstones
• Large Common Bile Duct Stone

Intervention

Procedure:
• ERCP
Common bile duct cannulation with a cannulation catheter
• Endoscopic Sphincterotomy
Endoscopic large sphincterotomy

Device:
• Large Balloon Dilatation of Oddi Sphincter
Large Balloon Dilatation : with the HERCULES, Cook 12, 15, 18 or 20 mm of diameter (adapted to stone diameter)

Procedure:
• Stone extraction
After dilatation, extraction of stones is done with dormia basket or extraction balloon and if not possible a mechanical lithotripsy is performed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Société Française d'Endoscopie Digestive

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of common bile duct clearance in one session of ERCP (endoscopic retrograde cholangiopancreatography)		1 month	No
Secondary	Number of patients with mild or severe BLEEDING (Morbidity) after ERCP	Immediate complications were noted : bleeding : mild if blood transfusion not necessary, and severe if blood transfusion necessary; Clinical data (pain, fever, vomiting...) are noted during first month; Clinical examination and blood tests (Blood count, C reactive protein, lipase blood test, hepatic tests, creatininemia) were noted at the 30th day after procedure; In case of bleeding suspected, a new ERCP was done; Number of patients with bleeding and with any complication in both groups were noted and compared	1 month	Yes
Secondary	Number of patients with mild or severe ACUTE PANCREATITIS (Morbidity) after ERCP	Immediate complications were noted : Acute pancreatitis : defined by the association of abdominal pain and lipase blood test > 3 N; Severity of acute pancreatitis was evaluated on CT index, and on evolution data; Clinical data (pain, fever, vomiting...) are noted during first month; Clinical examination and blood tests (Blood count, C reactive protein, lipase blood test, hepatic tests, creatininemia) were noted at the 30th day after procedure; Abdominal CT was performed in case of suspected acute pancreatitis; Number of patients with Acute Pancreatitis and any complication in both groups were noted and compared	1 month	Yes
Secondary	Number of patients with PERFORATION (Morbidity of ERCP)	Suspected on clinical data (pain, fever, vomiting...) and blood tests (Blood count, C reactive protein) noted during first day after ERCP: confirmed on CT; Number of patients with perforation in both groups were noted and compared, and global morbidity in both groups were noted and compared	1 day	Yes
Secondary	Number of patients with post ERCP INFECTION as angiocholitis, cholecystitis or urine infection, septicemia (Morbidity of ERCP)	Suspected on clinical data (pain, fever, vomiting...), blood tests (Blood count, C reactive protein, blood and urine cultures), noted during first day after ERCP, during 30th day and more if necessary in the meantime; Abdominal US and CT were performed if necessary; Number of patients with infection in both groups were noted and compared, and global morbidity in both groups were noted and compared	1 month	Yes
Secondary	GLOBAL MORBIDITY of ERCP (number of patients with bleeding and/or acute pancreatistis and/or perforation and/or infection)	- Number of patients with any complication as bleeding, acute pancreatitis, perforation, infection (as angiocholitis, cholecystitis, urine infection or septicemia) happened in both groups during the first month after the procedure were noted and compared	1 month	Yes
Secondary	MORTALITY of ERCP	- Number of death happened in both groups during the first month after the procedure were noted and compared	1 month	Yes
Secondary	Number of patients with recurrence of BDS	Clinical data (pain, fever, vomiting...) are noted during first month; Clinical examination and blood tests (Blood count, C reactive protein, lipase blood test, hepatic tests, creatininemia) were noted at the 30th day after procedure; In case of recurrence BDS suspected, abdominal US and/or CT and/or MRI and/or EUS (Endoscopic Ultrasonography) were done, and if BDS was confirmed, a new ERCP was done; Number of patients with recurrence of BDS in both groups in the first month after the procedure were noted and compared	1 month	No
Secondary	Length of procedure	For each patient, time was noted at the beginning and at the end of ERCP	Day one	No
Secondary	Cost of procedure	All the instrument used during ERCP (endoscopic retrograde cholangiopancreatography) for each patient were noted, and at the end of procedure cost of all instruments were recorded	Day one	No
Secondary	comparison of the frequency of mechanical lithotripsy of both groups	In both groups mechanical lithotripsy can be performed in case of impossibility of stone extraction. The rate of lithotripsy performed in both groups were compared	Day one	No