Hepaticojejunostomy With or Without Permanent Duodenal Access Loop in Treatment of Iatrogenic Bile Ducts Injuries, a Comparative 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.

Study Overview

• Status: Completed
• Conditions: Iatrogenic Bile Duct Injuries; Duodenojejunostomy Access Loop
• Intervention / Treatment: Procedure: hepaticojejunostomy without access loop; Procedure: duodenojejunostomy access loop

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sharqya
    • Zagazig, Sharqya, Egypt, 44519
      • Zagazig Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Iatrogenic bile duct injuries

Exclusion Criteria:

• Hepatobiliary malignancies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group I retrospective non access loop; patients with iatrogenic bile duct injuries, cases treated with hepaticojejunostomy without access loop	Procedure: hepaticojejunostomy without access loop; ROUX en Y hepaticojejunostomy without access loop
Active Comparator: GROUP II access loop group; patients with iatrogenic bile duct injuries, cases treated with hepaticojejunostomy with duodenojejunostomy access loop	Procedure: duodenojejunostomy access loop; ROUX en Y hepaticojejunostomy with duodenojejunal anastomosis as permanent access

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
results management of biliary enteric anastomosis complications	access loop used as a way for endoscopic management of complications	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative complications	Peritoneal collection Bile leak Wound infection Biliary stricture Recurrent cholangitis 2ry biliary cirrhosis Incisional hernia	( 1st month post operative)

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: October 31, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): November 5, 2019
• Last Update Submitted That Met QC Criteria: October 31, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: bile duct injury; duodenal access; hepaticojejonostomy
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: Hazem Nour access loop

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No