Iatrogenic Bile Duct InjuriesNCT04150679
Hepaticojejunostomy With or Without Permanent Duodenal Access Loop in Treatment of Iatrogenic Bile Ducts Injuries, a Comparative Study
A study testing duodenojejunostomy access loop and hepaticojejunostomy without access loop in people with Iatrogenic Bile Duct Injuries and Duodenojejunostomy Access Loop, run by Zagazig University at 1 site in Egypt.
Trial summary
A comparative study between two groups, group I; retrospective group, 21 patients underwent hepaticojejunostomy for treatment of iatrogenic bile duct injuries without access loop, in the period between January 2013 and December 2014, group II; a prospective group, 23 patients underwent hepaticojejunostomy for… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Iatrogenic Bile Duct Injuries, Duodenojejunostomy Access Loop
- What is being tested?
- duodenojejunostomy access loop and hepaticojejunostomy without access loop
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2013to May 2019
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Iatrogenic bile duct injuries
Who cannot join
- Hepatobiliary malignancies
Trial locations and contacts
1 site in 1 country.
About this study
A comparative study between two groups, group I; retrospective group, 21 patients underwent hepaticojejunostomy for treatment of iatrogenic bile duct injuries without access loop, in the period between January 2013 and December 2014, group II; a prospective group, 23 patients underwent hepaticojejunostomy for iatrogenic bile duct injuries with duodenojejunostomy as a permanent access loop, in the period between June 2017 and May 2019. Primary (early and late outcome) and management of complications data were collected and analyzed properly.
Read the detailed description
This study is a comparative study, comparing between two groups of patients with post cholecystectomy biliary injury, group (I) 21 patients, a retrospective group where data was collected from the medical records of the patients presented with post cholecystectomy biliary injury and managed with hepaticojejunostomy without access loop in a period of 2 years between January 2013 and December 2014, and group (II) 23 patients, a prospective group, where patients presented with post cholecystectomy biliary injury in a 2 years period between January 2017 and December 2018 , and managed by hepaticojejunostomy and jejunoduodenostomy as a permanent access loop .
the data collected from both groups included, demographic criteria of patients, type of the previous surgery, place of surgery, the class of the biliary injury according to bismuth classification, (according to Bismuth classification; type I (Low injury, stump length > 2 cm), type II) (higher injury, stump length < 2 cm), type III (high CHD injury but confluence is preserved), type IV (high injury both hepatic ducts are no more connected.). And any diagnostic or therapeutic intervention carried out before surgical management.
The detailed surgical management; in group I a roux en y hepaticojejunostomy was done, after abdominal exploration and identification of the level of injury or stricture a ROUX en Y loop of the jejunum was prepared 40 cm post duodenojujenal junction, it was separated and anastomosed to the jejunum at a more distal point ( 60 cm ) the proximal end of the distal loop was closed in two layers with Vicryl 3\0 the loop was extracted retrocolic towards the site of injury where a hepaticojejunostomy was done end( biliary)to side (jejunum with Vicryl 4\0 size single layer .
in the second group the same was done but with jejunoduodenostomy side to side at 5-10 cm distal to the site of hepaticoduodenostomy as a permanent access loop.
Follow up data either clinical, laboratory or radiologic were collected, findings of MRCP (if needed) was reported as primary outcome.
Secondary outcome (management of complications), including the operative time needed for correction of the complications, early and late postoperative morbidity and mortality.
The data was analyzed properly using SPSS 18, and presented in a suitable way using graphs figures and tables.
- Being tested
- duodenojejunostomy access loop, hepaticojejunostomy without access loop
- Keywords
- bile duct injury, duodenal access, hepaticojejonostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duodenojejunostomy access loopProcedure or surgery
ROUX en Y hepaticojejunostomy with duodenojejunal anastomosis as permanent access
hepaticojejunostomy without access loopProcedure or surgery
ROUX en Y hepaticojejunostomy without access loop
| Study group | Role | What they receive |
|---|---|---|
| group I retrospective non access loop | Active comparator | patients with iatrogenic bile duct injuries, cases treated with hepaticojejunostomy without access loop Receives: Procedure: hepaticojejunostomy without access loop |
| GROUP II access loop group | Active comparator | patients with iatrogenic bile duct injuries, cases treated with hepaticojejunostomy with duodenojejunostomy access loop Receives: Procedure: duodenojejunostomy access loop |
What is being measured
The primary outcome is the main question the study is designed to answer.
results management of biliary enteric anastomosis complications
access loop used as a way for endoscopic management of complications
Measured: 2 years
Secondary outcomes (1)
postoperative complications
Peritoneal collection Bile leak Wound infection Biliary stricture Recurrent cholangitis 2ry biliary cirrhosis Incisional hernia
Measured: ( 1st month post operative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study startJan 2013
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iatrogenic Bile Duct InjuriesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- group I, retrospective group , data retrieved from medical records, cases treated with hepaticojejunostomy without access group II prospective group cases treated with hepaticojejunostomy with access
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hazem Nour Abdellatif, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150679
- Sponsor's protocol ID
- Hazem Nour access loop
- Status last verified
- Oct 2019
- First submitted
- 31 Oct 2019
- Last updated
- 5 Nov 2019
- 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 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepaticojejunostomy With or Without Permanent Duodenal Access Loop in Treatment of Iatrogenic Bile Ducts Injuries, a Comparative Study
- ClinicalTrials.gov ID
- NCT04150679
- Acronym / sponsor ID
- Hazem Nour access loop
- Keywords
- bile duct injury, duodenal access, hepaticojejonostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- Jan 2013 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 5 Nov 2019 (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.
A comparative study between two groups, group I; retrospective group, 21 patients underwent hepaticojejunostomy for treatment of iatrogenic bile duct injuries without access loop, in the period between January 2013 and December 2014, group II; a prospective group, 23 patients underwent hepaticojejunostomy for iatrogenic bile duct injuries with duodenojejunostomy as a permanent access loop, in the period between June 2017 and May 2019. Primary (early and late outcome) and management of complications data were collected and analyzed properly.
Detailed description
This study is a comparative study, comparing between two groups of patients with post cholecystectomy biliary injury, group (I) 21 patients, a retrospective group where data was collected from the medical records of the patients presented with post cholecystectomy biliary injury and managed with hepaticojejunostomy without access loop in a period of 2 years between January 2013 and December 2014, and group (II) 23 patients, a prospective group, where patients presented with post cholecystectomy biliary injury in a 2 years period between January 2017 and December 2018 , and managed by hepaticojejunostomy and jejunoduodenostomy as a permanent access loop .
the data collected from both groups included, demographic criteria of patients, type of the previous surgery, place of surgery, the class of the biliary injury according to bismuth classification, (according to Bismuth classification; type I (Low injury, stump length > 2 cm), type II) (higher injury, stump length < 2 cm), type III (high CHD injury but confluence is preserved), type IV (high injury both hepatic ducts are no more connected.). And any diagnostic or therapeutic intervention carried out before surgical management.
The detailed surgical management; in group I a roux en y hepaticojejunostomy was done, after abdominal exploration and identification of the level of injury or stricture a ROUX en Y loop of the jejunum was prepared 40 cm post duodenojujenal junction, it was separated and anastomosed to the jejunum at a more distal point ( 60 cm ) the proximal end of the distal loop was closed in two layers with Vicryl 3\0 the loop was extracted retrocolic towards the site of injury where a hepaticojejunostomy was done end( biliary)to side (jejunum with Vicryl 4\0 size single layer .
in the second group the same was done but with jejunoduodenostomy side to side at 5-10 cm distal to the site of hepaticoduodenostomy as a permanent access loop.
Follow up data either clinical, laboratory or radiologic were collected, findings of MRCP (if needed) was reported as primary outcome.
Secondary outcome (management of complications), including the operative time needed for correction of the complications, early and late postoperative morbidity and mortality.
The data was analyzed properly using SPSS 18, and presented in a suitable way using graphs figures and tables.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- group I, retrospective group , data retrieved from medical records, cases treated with hepaticojejunostomy without access group II prospective group cases treated with hepaticojejunostomy with access
| Arm | Type | Receives |
|---|---|---|
| group I retrospective non access loop | Active comparator | Procedure: hepaticojejunostomy without access looppatients with iatrogenic bile duct injuries, cases treated with hepaticojejunostomy without access loop |
| GROUP II access loop group | Active comparator | Procedure: duodenojejunostomy access looppatients with iatrogenic bile duct injuries, cases treated with hepaticojejunostomy with duodenojejunostomy access loop |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Iatrogenic bile duct injuries
Key exclusion criteria (1 listed)
- Hepatobiliary malignancies
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 |
|---|---|---|
| duodenojejunostomy access loopROUX en Y hepaticojejunostomy with duodenojejunal anastomosis as permanent access | Procedure or surgery | GROUP II access loop group |
| hepaticojejunostomy without access loopROUX en Y hepaticojejunostomy without access loop | Procedure or surgery | group I retrospective non access loop |
Primary outcome
results management of biliary enteric anastomosis complications
Time frame: 2 years
access loop used as a way for endoscopic management of complications
1 secondary outcome
postoperative complications
Time frame: ( 1st month post operative)
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 5 Nov 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Iatrogenic Bile Duct Injuries
RecruitingObservational study
Endoscopic Treatment of Post Surgical Biliary Tract Injury
Biliary Tract Injuries
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing duodenojejunostomy access loop and hepaticojejunostomy without access loop in people with Iatrogenic Bile Duct Injuries and Duodenojejunostomy Access Loop, run by Zagazig 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 5 Nov 2019. 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?
results management of biliary enteric anastomosis complications (time frame: 2 years). 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 5 Nov 2019.