CholedocholithiasisNCT04463381
Choledochotomy Techniques During LCBDE
An observational study of Choledocholithiasis, run by Sohag University at 1 site in Egypt.
Trial summary
complications after laparoscopic common bile duct exploration (LCBDE) regarding the choledochotomy technique have not been adequately studied in the literature. Therefore, this study aimed to retrospectively analyze and compare the impact of choledochotomy techniques during LCBDE among patients with… Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Choledocholithiasis
- What is being tested?
- choledochotomy techniques during LCBDE
- Type of treatment
- Surgery or procedure
- How many people
- 85 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2014to 1 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: During the study period, 85 patients (52 females and 33 males) were enrolled in this study which they were complaining of manifestations of CBD stones and treated using laparoscopic approaches, using various choledochotomy techniques.
Who may be able to join
- All adult patients with choledocholithiasis who underwent LCBDE combined with LC were enrolled in this study. No limitations as regards the stone sizes or numbers were considered. The CBD diameter should be at least ± 1 cm.
Who cannot join
- Exclusion criteria were normal caliber or stenosed CBD, or the presence of overt cholangitis. Additionally, treated patients with the trans-cystic approach for stone extraction were excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Choledochotomy Techniques During Laparoscopic CBD Exploration on Short- and Long-term Clinical Outcomes: Time to Change Concepts
complications after laparoscopic common bile duct exploration (LCBDE) regarding the choledochotomy technique have not been adequately studied in the literature. Therefore, this study aimed to retrospectively analyze and compare the impact of choledochotomy techniques during LCBDE among patients with choledocholithiasis during the early and late postoperative periods.
Read the detailed description
Background: complications after laparoscopic common bile duct exploration (LCBDE) regarding the choledochotomy technique have not been adequately studied in the literature. Therefore, this study aimed to retrospectively analyze and compare the impact of choledochotomy techniques during LCBDE among patients with choledocholithiasis during the early and late postoperative periods.
Methods: from March 2014 to February 2018, 85 patients with choledocholithiasis (52 females and 33 males) were enrolled in this study. These patients were treated by LCBDE using various choledochotomy techniques, including scalpel or scissor (28 patients, 33%) in group I, using diathermy hook (35 patients, 41%) in group II, or using an ultrasonic device (22 patients, 26 %) in group III. Postoperative follow-up was done for assessment of all possible complications either early (within 3-6 months postoperatively), or late (2-6 years postoperatively) with meticulous observation and study of any relevant postoperative event.
- Conditions
- Choledocholithiasis
- Being tested
- choledochotomy techniques during LCBDE
- Keywords
- choledochotomy technique, CBD stones, choledocholithiasis
- Medical subject headings
- Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
choledochotomy techniques during LCBDEProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | sharp choledochotomy by a scalpel or scissor Receives: Procedure: choledochotomy techniques during LCBDE | |
| Group 2 | choledochotomy by a diathermy hook Receives: Procedure: choledochotomy techniques during LCBDE | |
| Group 3 | choledochotomy by an ultrasonic device Receives: Procedure: choledochotomy techniques during LCBDE |
What is being measured
The primary outcome is the main question the study is designed to answer.
biliary leakage/fistula
According to the international study group of liver surgery, bile leakage is defined as fluid with an elevated bilirubin level (3 times higher than the serum bilirubin measured at the same time) in the abdominal drain or the intra-abdominal fluid on or after POD 3, or as the need for radiologic intervention because of biliary collections or re-laparotomy resulting from biliary peritonitis
Measured: first postoperative 6 months up to 6 years postoperatively
biliary stricture
The biliary stricture is known as abnormal narrowing of the bile duct associated with the rising of cholestasis indexes. Additionally, it has required an invasive treatment such as ERCP, percutaneous transhepatic drainage, or re-surgery [16]. Biliary complications were diagnosed by trans-tubal cholangiography or through MRCP and could be managed conservatively, ERCP, if there is an accessible route, PTD or surgical intervention.
Measured: 2-6 years
Secondary outcomes (9)
operative time
from incision to closure
Measured: from incision to closure
intraoperative bleeding
in mm
Measured: during surgery
conversion rate
from laparoscopy to open
Measured: during surgery
jaundice
missed stone
Measured: 2-6 years
wound sepsis
infection of the wound
Measured: 2-6 years
cholangitis
inflammation of the biliary system
Measured: 2-6 years
wound dehiscence
Gapped wound
Measured: 2-6 years
Peritoneal sepsis and abscess
peritonitis
Measured: first postoperative 6 months
Recurrent stones
recurrence
Measured: 2-6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start1 Mar 2014
- Primary completion28 Feb 2018
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholedocholithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Ali Ahmed Ali, Sohag University
- Investigators
- Emad Ali Ahmed, MD, PhD, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463381
- Sponsor's protocol ID
- 22/05/2020
- Status last verified
- Jul 2020
- First submitted
- 3 Jul 2020
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Choledochotomy Techniques During Laparoscopic CBD Exploration on Short- and Long-term Clinical Outcomes: Time to Change Concepts
- ClinicalTrials.gov ID
- NCT04463381
- Acronym / sponsor ID
- 22/05/2020
- Conditions
- Choledocholithiasis
- Keywords
- choledochotomy technique, CBD stones, choledocholithiasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 9 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
complications after laparoscopic common bile duct exploration (LCBDE) regarding the choledochotomy technique have not been adequately studied in the literature. Therefore, this study aimed to retrospectively analyze and compare the impact of choledochotomy techniques during LCBDE among patients with choledocholithiasis during the early and late postoperative periods.
Detailed description
Background: complications after laparoscopic common bile duct exploration (LCBDE) regarding the choledochotomy technique have not been adequately studied in the literature. Therefore, this study aimed to retrospectively analyze and compare the impact of choledochotomy techniques during LCBDE among patients with choledocholithiasis during the early and late postoperative periods.
Methods: from March 2014 to February 2018, 85 patients with choledocholithiasis (52 females and 33 males) were enrolled in this study. These patients were treated by LCBDE using various choledochotomy techniques, including scalpel or scissor (28 patients, 33%) in group I, using diathermy hook (35 patients, 41%) in group II, or using an ultrasonic device (22 patients, 26 %) in group III. Postoperative follow-up was done for assessment of all possible complications either early (within 3-6 months postoperatively), or late (2-6 years postoperatively) with meticulous observation and study of any relevant postoperative event.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: choledochotomy techniques during LCBDEsharp choledochotomy by a scalpel or scissor |
| Group 2 | – | Procedure: choledochotomy techniques during LCBDEcholedochotomy by a diathermy hook |
| Group 3 | – | Procedure: choledochotomy techniques during LCBDEcholedochotomy by an ultrasonic device |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- During the study period, 85 patients (52 females and 33 males) were enrolled in this study which they were complaining of manifestations of CBD stones and treated using laparoscopic approaches, using various choledochotomy techniques.
Key inclusion criteria (1 listed)
- All adult patients with choledocholithiasis who underwent LCBDE combined with LC were enrolled in this study. No limitations as regards the stone sizes or numbers were considered. The CBD diameter should be at least ± 1 cm.
Key exclusion criteria (1 listed)
- Exclusion criteria were normal caliber or stenosed CBD, or the presence of overt cholangitis. Additionally, treated patients with the trans-cystic approach for stone extraction were excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| choledochotomy techniques during LCBDE | Procedure or surgery | Group 1, Group 2, Group 3 |
Primary outcome
biliary leakage/fistula
Time frame: first postoperative 6 months up to 6 years postoperatively
According to the international study group of liver surgery, bile leakage is defined as fluid with an elevated bilirubin level (3 times higher than the serum bilirubin measured at the same time) in the abdominal drain or the intra-abdominal fluid on or after POD 3, or as the need for radiologic intervention because of biliary collections or re-laparotomy resulting from biliary peritonitis
biliary stricture
Time frame: 2-6 years
The biliary stricture is known as abnormal narrowing of the bile duct associated with the rising of cholestasis indexes. Additionally, it has required an invasive treatment such as ERCP, percutaneous transhepatic drainage, or re-surgery [16]. Biliary complications were diagnosed by trans-tubal cholangiography or through MRCP and could be managed conservatively, ERCP, if there is an accessible route, PTD or surgical intervention.
9 secondary outcomes
operative time
Time frame: from incision to closure
intraoperative bleeding
Time frame: during surgery
conversion rate
Time frame: during surgery
jaundice
Time frame: 2-6 years
wound sepsis
Time frame: 2-6 years
cholangitis
Time frame: 2-6 years
wound dehiscence
Time frame: 2-6 years
Peritoneal sepsis and abscess
Time frame: first postoperative 6 months
Recurrent stones
Time frame: 2-6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emad Ali Ahmed, MD, PhD principal investigator
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Choledocholithiasis, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biliary leakage/fistula (time frame: first postoperative 6 months up to 6 years postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2020; AzTrials last refreshed its copy on 27 Oct 2026.