Hepaticojejunostomy With or Without Permanent Duodenal Access Loop in Treatment of Iatrogenic Bile Ducts Injuries, a Comparative Study
Primary Purpose
Iatrogenic Bile Duct Injuries, Duodenojejunostomy Access Loop
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
duodenojejunostomy access loop
hepaticojejunostomy without access loop
Sponsored by
About this trial
This is an interventional health services research trial for Iatrogenic Bile Duct Injuries focused on measuring bile duct injury, duodenal access, hepaticojejonostomy
Eligibility Criteria
Inclusion Criteria:
• Iatrogenic bile duct injuries
Exclusion Criteria:
• Hepatobiliary malignancies
Sites / Locations
- Zagazig Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
group I retrospective non access loop
GROUP II access loop group
Arm Description
patients with iatrogenic bile duct injuries, cases treated with hepaticojejunostomy without access loop
patients with iatrogenic bile duct injuries, cases treated with hepaticojejunostomy with duodenojejunostomy access loop
Outcomes
Primary Outcome Measures
results management of biliary enteric anastomosis complications
access loop used as a way for endoscopic management of complications
Secondary Outcome Measures
postoperative complications
Peritoneal collection Bile leak Wound infection Biliary stricture Recurrent cholangitis 2ry biliary cirrhosis Incisional hernia
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04150679
Brief Title
Hepaticojejunostomy With or Without Permanent Duodenal Access Loop in Treatment of Iatrogenic Bile Ducts Injuries, a Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iatrogenic Bile Duct Injuries, Duodenojejunostomy Access Loop
Keywords
bile duct injury, duodenal access, hepaticojejonostomy
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group I retrospective non access loop
Arm Type
Active Comparator
Arm Description
patients with iatrogenic bile duct injuries, cases treated with hepaticojejunostomy without access loop
Arm Title
GROUP II access loop group
Arm Type
Active Comparator
Arm Description
patients with iatrogenic bile duct injuries, cases treated with hepaticojejunostomy with duodenojejunostomy access loop
Intervention Type
Procedure
Intervention Name(s)
duodenojejunostomy access loop
Intervention Description
ROUX en Y hepaticojejunostomy with duodenojejunal anastomosis as permanent access
Intervention Type
Procedure
Intervention Name(s)
hepaticojejunostomy without access loop
Intervention Description
ROUX en Y hepaticojejunostomy without access loop
Primary Outcome Measure Information:
Title
results management of biliary enteric anastomosis complications
Description
access loop used as a way for endoscopic management of complications
Time Frame
2 years
Secondary Outcome Measure Information:
Title
postoperative complications
Description
Peritoneal collection Bile leak Wound infection Biliary stricture Recurrent cholangitis 2ry biliary cirrhosis Incisional hernia
Time Frame
( 1st month post operative)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Iatrogenic bile duct injuries
Exclusion Criteria:
• Hepatobiliary malignancies
Facility Information:
Facility Name
Zagazig Faculty of Medicine
City
Zagazig
State/Province
Sharqya
ZIP/Postal Code
44519
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Hepaticojejunostomy With or Without Permanent Duodenal Access Loop in Treatment of Iatrogenic Bile Ducts Injuries, a Comparative Study
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