Intraoperative endoscopic retrograde sphincterotomy as a modality of treatment of choledocholithiasis

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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:

Secondary indentifying numbers:

cncma002

Source(s) of monetary or material support:

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 Ruiz Torres, MD

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

Country:

Not entered

Zip Code:

Not entered

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:

No

Research ethics committees:

Approved by Ethic Committee of National Center for Minimal Access Surgery on 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

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.

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:

N/A

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, MD

Middle Name:

Ernesto

Last Name:

Barreras González

Affiliation:

National Center for Minimal Access Surgery

Postal Address:

Párraga St e/ San Mariano y Vista Alegre. 10 de Octubre.

City:

Havana City

Country:

Cuba

Zip Code:

Not entered

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, MD

Middle Name:

Ernesto

Last Name:

Barreras González

Affiliation:

National Center for Minimal Access Surgery

Postal Address:

Párraga St e/ San Mariano y Vista Alegre. 10 de Octubre.

City:

Havana City.

Country:

Cuba

Zip Code:

Not entered

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:

2008-11-10 19:00

Link to the spanish version:

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Intraoperative endoscopic retrograde sphincterotomy as a modality of treatment of choledocholithiasis

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