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

NCT ID: NCT04150679

Last Updated: 2019-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2019-05-31

Brief Summary

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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

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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.

Conditions

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Iatrogenic Bile Duct Injuries Duodenojejunostomy Access Loop

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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group I retrospective non access loop

patients with iatrogenic bile duct injuries, cases treated with hepaticojejunostomy without access loop

Group Type ACTIVE_COMPARATOR

hepaticojejunostomy without access loop

Intervention Type PROCEDURE

ROUX en Y hepaticojejunostomy without access loop

GROUP II access loop group

patients with iatrogenic bile duct injuries, cases treated with hepaticojejunostomy with duodenojejunostomy access loop

Group Type ACTIVE_COMPARATOR

duodenojejunostomy access loop

Intervention Type PROCEDURE

ROUX en Y hepaticojejunostomy with duodenojejunal anastomosis as permanent access

Interventions

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duodenojejunostomy access loop

ROUX en Y hepaticojejunostomy with duodenojejunal anastomosis as permanent access

Intervention Type PROCEDURE

hepaticojejunostomy without access loop

ROUX en Y hepaticojejunostomy without access loop

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

• Iatrogenic bile duct injuries

Exclusion Criteria

• Hepatobiliary malignancies
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hazem Nour Abdellatif

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zagazig Faculty of Medicine

Zagazig, Sharqya, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Hazem Nour access loop

Identifier Type: -

Identifier Source: org_study_id

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