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Intraoperative endoscopic retrograde sphincterotomy as a modality of treatment of choledocholithiasis
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10 April 2013 - 10:18am
by Webmaster
9 November 2016 - 10:41am
by lazara
Changes to
Clinical sites
-
No
+
Not applicable
Changes to
Research ethics committees
-
Approved by Ethic Committee of
National Center for Minimal Access Surgery
on
May 30, 2006
+
National Center for Minimal Access Surgery
,
May 30, 2006
Changes to
First name
-
Julián
Ruiz Torres, MD
+
Julián
Changes to
Last name
-
Not entered
+
Ruiz Torres
Changes to
Health condition(s) code
-
+
Choledocholithiasis
+
Cholelithiasis
+
Common Bile Duct Diseases
+
Bile Duct Diseases
+
Biliary Tract Diseases
+
Digestive System Diseases
Changes to
Medical Specialty
-
+
Specialist II degree Gastroenterology
Changes to
Affiliation
-
Not entered
+
National Center for Minimal Access Surgery
Changes to
Postal address
-
Not entered
+
Párraga street 215 e/ San Mariano and Vista Alegre, La Víbora, 10 de Octubre
Changes to
Intervention code
-
+
Sphincterotomy, Endoscopic
+
Cholangiography
+
Cholecystectomy, Laparoscopic
+
Cholangiopancreatography, Endoscopic Retrograde
Changes to
City
-
Not entered
+
Havana
Changes to
Country
-
Not entered
+
Cuba
Changes to
Zip Code
-
Not entered
+
10500
Changes to
Maximum age
-
N/A
+
None
Changes to
First Name
-
Javier
, MD
+
Javier
Changes to
Specialty
-
+
Specialist of II Degree in General Surgery
Changes to
City
-
Havana
City
+
Havana
Changes to
Zip Code
-
Not entered
+
10500
Changes to
First Name
-
Javier
, MD
+
Javier
Changes to
Specialty
-
+
Specialist of II Degree in General Surgery
Changes to
City
-
Havana
City.
+
Havana
Changes to
Zip Code
-
Not entered
+
10500
Changes to
Record Verification Date
-
2008-
11
-10 19:00
+
2016/
11
/09
Changes to
Next update date
-
+
2017/11/09
Changes to
Issuing authority of the secondary identifying numbers
-
+
National Center for Minimal Access Surgery
Changes to
Secondary sponsor
-
No
+
Not applicable
Changes to
Source(s) of monetary or material support
-
MINSAP
+
Ministry of Public Health,
MINSAP
Revision of 9 November 2016 - 10:41am:
Intraoperative endoscopic retrograde sphincterotomy as a modality of treatment of choledocholithiasis
General information
Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.
Scientific title:
Intraoperative endoscopic retrograde sphincterotomy as a modality of treatment of choledocholithiasis
Secondary indentifying numbers:
cncma002
Issuing authority of the secondary identifying numbers:
National Center for Minimal Access Surgery
Primary sponsor:
National Center for Minimal Access Surgery
Secondary sponsor:
Not applicable
Source(s) of monetary or material support:
Ministry of Public Health, MINSAP
Authorization for beginning
Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.
Regulatory instance to authorize the initiation of the study:
Only approved by Ethics Committees
Principal investigator
Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
First name:
Julián
Last name:
Ruiz Torres
Medical Specialty :
Specialist II degree Gastroenterology
Affiliation:
National Center for Minimal Access Surgery
Postal address:
Párraga street 215 e/ San Mariano and Vista Alegre, La Víbora, 10 de Octubre
City:
Havana
Country:
Cuba
Zip Code:
10500
Telephone:
+53-76495332
Email address:
email@not.entered
Clinical sites to participate
Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.
Countries of recruitment:
Cuba
Clinical sites:
Not applicable
Research ethics committees:
National Center for Minimal Access Surgery, May 30, 2006
Recruitment status
Section to complete information about the recruitment status and the date of first enrolment subject
Recruitment status:
Recruiting
Date of first enrollment:
06/11/2007
Health condition and Intervention
Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).
Health condition(s) or Problem(s) studied:
choledocholithiasis
Health condition(s) code:
Choledocholithiasis
Cholelithiasis
Common Bile Duct Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Intervention(s):
A prospective randomized controlled clinical trial compared three management options for the patients with choledocholithiasis. In summary, the intake was restricted to fit patients (ASA I and II) in whom choledocholithiasis were proven or suspected on the basis of the clinical features, liver function tests and external ultrasound findings. Essential investigations included full liver function tests and external ultrasound examination of the gallbladder and bile ducts and if not any exclusion criterion was present, the patients were randomized in three groups (I-experimental, II-control, III-control) by the sealed-envelope method based on a computer-generated list. The experimental group (I) received intraoperative cholangiography (IOC) to confirm the choledocholithiasis followed by laparoscopic cholecystectomy (LC) associated with intraoperative endoscopic retrograde cholangiography (ERC) and endoscopic stone extraction (ESE). The control group (II) received preoperative ERC with ESE followed by LC during the same hospital admission (24-48 hours after). The control group (III) received IOC to confirm the choledocholithiasis followed by LC associated with laparoscopic common bile duct exploration (LCBDE) with laparoscopic stone extraction.
Intervention code:
Sphincterotomy, Endoscopic
Cholangiography
Cholecystectomy, Laparoscopic
Cholangiopancreatography, Endoscopic Retrograde
Outcomes and Timepoint
Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
"Success on the procedures of stone extraction", timepoint: at the end of surgical procedure. "Morbidity and mortality", timepoint: at the follow-up, on 30 days after procedure.
Key secondary outcomes:
"Operative time”, timepoint: at the end of surgical procedure. "Hospital stay", timepoint: at the follow-up, on 1-7 days after procedure. "Diagnosis of residual choledocholithiasis", timepoint: at the follow-up, on 2 years after procedure. "Cost of surgical procedure”, timepoint: at the end of hospital stay.
Selection criterias
Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.
Gender:
Male/Female
Minimum age:
15 years
Maximum age:
None
Inclusion criteria:
Patients older than 15 years-old, both gender, with gallbladder in situ and preoperative suspect of choledocholithiasis CLINICAL FEATURES: Jaundice – Recent acute pancreatitis or cholangitis – Colic pain with jaundice and pyrexia LIVER FUNCTION TESTS: Elevated bilirubin, alkaline phosphatase and GGT EXTERNAL ULTRASOUND FINDINGS Common bile duct > 8 mm- Common bile duct Stone
Exclusion criteria:
- Acute cholecystitis – Acute cholangitis – Acute pancreatitis - Contraindication for laparoscopic surgery and/or ERCP – Anesthetic contraindication ( ASA IV y V)- Pregnant woman- ERCP previous- Extensive adhesions in abdominal right quadrant- Patients that refuse the treatment
Type of population:
Children and Adults
Type of participant:
Patients
Study design
Section to complete information about the characteristics of the study design.
Type study:
Interventional
Purpose:
Treatment
Allocation:
Randomized controlled trial
Masking:
Single Blind
Control group:
Active
Study design:
Parallel
Phase:
3
Target sample size:
450 patients (150 patients per group)
Contact for public queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status
First Name:
Javier
Middle Name:
Ernesto
Last Name:
Barreras González
Specialty:
Specialist of II Degree in General Surgery
Affiliation:
National Center for Minimal Access Surgery
Postal Address:
Párraga St e/ San Mariano y Vista Alegre. 10 de Octubre.
City:
Havana
Country:
Cuba
Zip Code:
10500
Telephone:
(537) 649-5333 | FAX: (537) 649-0150
Email :
javier@cce.sld.cu
Contact for scientific queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.
First Name:
Javier
Middle Name:
Ernesto
Last Name:
Barreras González
Specialty:
Specialist of II Degree in General Surgery
Affiliation:
National Center for Minimal Access Surgery
Postal Address:
Párraga St e/ San Mariano y Vista Alegre. 10 de Octubre.
City:
Havana
Country:
Cuba
Zip Code:
10500
Telephone:
(537) 649-5333 | FAX: (537) 649-0150
Email :
javier@cce.sld.cu
Registration and Update
Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).
Primary registry:
RPCEC
Unique ID number:
RPCEC00000013
Date of Registration in Primary Registry:
2008-11-14
Record Verification Date:
2016/11/09
Next update date:
2017/11/09
Link to the spanish version:
Click here
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