Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000162213
Ethics application status
Approved
Date submitted
24/03/2009
Date registered
1/04/2009
Date last updated
1/04/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Prospective randomized trial of two-stage treatment with preoperative endoscopic retrograde cholangiopancreatography (ERCP) versus single-stage treatment with intraoperative ERCP in patients with gallbladder and bile duct stones
Scientific title
Prospective randomized trial of two-stage treatment with preoperative endoscopic retrograde cholangiopancreatography (ERCP) versus single-stage treatment with intraoperative ERCP in patients with gallbladder and bile duct stones for stone clearance
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with gallbladder and bile duct stones 4523 0
Condition category
Condition code
Surgery 4810 4810 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single-stage treatment with intraoperative ERCP (ERCP is a technique that combines the use of endoscopy and fluoroscopy to diagnose and treat certain disease of the biliary or pancreatic ductal systems, e.g. biliary stone. Then a flexible endoscope is inserted through the mouth, into the duodenum where the ampulla of Vater exists. The region can be directly visualized with the endoscopic camera. A plastic cannula is inserted through the ampulla, and radiocontrast is injected into the bile ducts. Fluoroscopy is used to look for any pathology such as stones. Then, endoscopist can treat it accordingly. The procedure lasts around 30 minutes) and laparoscopic cholecystectomy (Gallbladder with stones was dissected and removed by minimally invasive surgery with laparoscopic approach by four small wound ports. Intraoperative cholangiogram may be performed also, if needed. The procedure lasts around 90 minutes); Patients will undergo laparoscopic cholecystectomy and intraoperative ERCP simutaneously under general anestheisa.
Intervention code [1] 4281 0
Treatment: Surgery
Comparator / control treatment
Two-stage treatment with preoperative ERCP (ERCP will be performed under sedation; The procedure lasts around 30 minutes) and then laparoscopic cholecystectomy (The procedure lasts around 90 minutes); Patients will undergo preoperative ERCP and after a short period of clinical monitoring (24–72 hours), laparoscopic cholecystectomy will be received.
Control group
Active

Outcomes
Primary outcome [1] 5668 0
Failure of ERCP (inability to visualize or to cannulate the common bile duct)
Timepoint [1] 5668 0
After ERCP
Secondary outcome [1] 241555 0
Failure of stones extraction (inability to obtain complete common bile duct stones clearance at completion cholangiogram)
Timepoint [1] 241555 0
After ERCP

Eligibility
Key inclusion criteria
1. Age ranged from 18-75 years old
2. Patients with ultrasonography(USG)/magnetic resonance cholangiopancreatography (MRCP)/computed tomography (CT) scan evidence of gallbladder stones and common bile duct (CBD) stones
3. Patients recovered from episode of acute cholangitis or biliary pancreatitis, and were treated with ERCP and temporary biliary stenting for the biliary stone obstruction during acute phase. Patients were randomized only if they demonstrated evidence of resolved acute episode, as determined by a decreasing white cell count, bilirubin level, fever and reduced abdominal pain
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with acute cholangitis or acute severe pancreatitis at acute phase
2. American Society of Anesthesiologists (ASA) class IV and V health status
3. Patients with suspected biliary malignancy
4. Patients with Mirizzi syndrome
5. Patients with recurrent pyogenic cholangitis
6. Patients with previous cholecystectomy/bile duct exploration/gastrectomy
7. Patients have contraindications to ERCP/laparoscopic surgery
8. On long term anticoagulant treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
88
Accrual to date
Final
Recruitment outside Australia
Country [1] 1696 0
Hong Kong
State/province [1] 1696 0

Funding & Sponsors
Funding source category [1] 4709 0
Self funded/Unfunded
Name [1] 4709 0
Country [1] 4709 0
Primary sponsor type
Hospital
Name
Department of Surgery, Pamela Youde Nethersole Eastern Hospital
Address
3 Lok Man Road, Chai Wan, Hong Kong
Country
Hong Kong
Secondary sponsor category [1] 4255 0
None
Name [1] 4255 0
Address [1] 4255 0
Country [1] 4255 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6744 0
The Ethics Committee of Hong Kong East Cluster of Hospital Authority
Ethics committee address [1] 6744 0
Ethics committee country [1] 6744 0
Hong Kong
Date submitted for ethics approval [1] 6744 0
Approval date [1] 6744 0
20/03/2009
Ethics approval number [1] 6744 0
HKEC-2009-006

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29431 0
Address 29431 0
Country 29431 0
Phone 29431 0
Fax 29431 0
Email 29431 0
Contact person for public queries
Name 12678 0
Lai Eric C.H.
Address 12678 0
Department of Surgery, Pamela Youde Nethersole Eastern Hospital, 3 Lok Man Road, Chai Wan, Hong Kong
Country 12678 0
Hong Kong
Phone 12678 0
852-2595 6111
Fax 12678 0
Email 12678 0
[email protected]
Contact person for scientific queries
Name 3606 0
Lai Eric C.H
Address 3606 0
Department of Surgery, Pamela Youde Nethersole Eastern Hospital, 3 Lok Man Road, Chai Wan, Hong Kong
Country 3606 0
Hong Kong
Phone 3606 0
852-2595 6111
Fax 3606 0
Email 3606 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.