Endoscopic Access Loop With Bilio-enteric Anastomosis: A Prospective Randomized Comparison Between Gastric and Subcutaneous Accesses

August 16, 2017 updated by: Mohamad Raafat, Assiut University

Roux-en-Y hepaticojejunostomy is the standard procedure used by most hepatobiliary surgeons for biliary reconstruction following iatrogenic bile duct injury, benign and malignant CBD strictures, choledochal cysts and biliary tract tumors management. The incidence of anastomotic stricture following hepaticojejunostomy in experienced centers ranges between 5%-22%. Hepaticojejunostomy stricture is a serious complication of biliary surgery, if untreated, can lead to repeated cholangitis, intrahepatic stones formation, biliary cirrhosis, hepatic failure and eventually death.

Revision of hepaticojejunostomy is a complex procedure, the surgical procedure being made difficult by the sequelae of long-standing unrelieved biliary obstruction like portal hypertension due to secondary biliary cirrhosis, atrophy of liver lobes and presence of cholangiolytic liver abscess.

Endoscopic management is not only the least invasive but also very effective via either balloon dilatation or stenting of the stricture. In patients with "Roux-en-Y" hepaticojejunostomy, the endoscopic access to the anastomosis is hampered by the distance traveled by the jejunal loop until reaching the angle of the enteral anastomosis.

Many modifications of hepaticojejunostomy to provide permanent endoscopic access have been described in the literature including duodenal, gastric and subcutaneous access loops.

Gastric access loop was first described by Sitaram et al. Ten patients had undergone gastric access loop. Access loop was entered easily with the gastroscope in five patients in whom it was attempted. In a series with 16 cases, Hamad MA and El-Amin H assessed different construction of gastric access loop in the form of bilioenterogastrostomy the overall success rate of endoscopic access to the HJ through the three types of BEG was 87.5%, while it was 100% for BEG type III, which is a construction similar to the previous series (BEG) type.

Subcutaneous loop access was described by Chen et al. and by Huston et al. In Hutson's series of 7 patients, recurrent strictures were treated with repeated balloon dilations. The stone extractions were all successful. In most series, the subcutaneous loop was used for management os HJ stricture and intrahepatic stones by radiologic intervention. Recently the subcutaneous loop can be used as an endoscopic biliary access.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Detailed Description

This study is a prospective randomized controlled study; which will include all patients who will undergo Roux-en-Y hepaticojejunostomy reconstruction during the period from 9-2017 to 12-2019.

* Methodology:

Patients will be randomized into three groups according to the surgical procedure performed as follows:

  • Group A: Patients undergoing modified hepaticojejunostomy with gastric access loop
  • Group B: Patients undergoing modified hepaticojejunostomy with subcutaneous access loop

  • Group C: Patients undergoing standard hepaticojejunostomy with no endoscopic access loop

    • Pre-operative preparation:

For all patients, full medical history, clinical examination, laboratory investigations in the form of complete blood count (CBC), prothrombin time and concentration (PTT), liver function tests (LFT) and kidney function tests (KFT) will be performed.

Imaging studies will also be carried out in the form of abdominal ultrasonography (US), computerized tomography scan (CT) of the abdomen and magnetic resonance cholangiography (MRC) if indicated.

ERCP will be performed, whenever applicable, whether for diagnosis or therapeutic trial.

* Surgical Technique:

For gastric access loop:

  • Surgical technique: under general intubation anesthesia, a generous right subcostal incision is performed and could be extended on demand upward to the xiphoid process and/or to the left subcostal area. Thorough dissection and adhesiolysis is performed to reach the CBD and prepare the unaffected proximal part for anastomosis. The Roux jejunal loop is prepared and passed retrocolic to reach the porta hepatis.
  • Then, the hepaticojejunostomy is done via end to side anastomosis using interrupted sutures of polyglactin of 3-0 or 4-0 size. The anastomosis is done 10-15 cm away from the free distal end of the Roux jejunum loop to allow anastomosis without tension to the stomach. A biliary stent may be optionally placed according to operative circumstances and is brought out through the anterior abdominal wall.
  • The end of the Roux jejunal loop taken up for hepaticojejunostomy is not closed but is anastomosed to the anterior wall of the gastric antrum near the pyloric orifice.
  • All the enterogastrostomies and enteroenterostomies were in the form of single-layer continuous sutures of polyglactin of 3-0 size. An intraperitoneal drain was left in the hepatorenal pouch before closing the incision.

For subcutaneous access loop:

In the subcutaneous access loop, the same steps are done for performing roux-en-Y hepaticojejunostomy.

The closed free end of roux loop is passed through the anterior abdominal wall in the right subcostal area and then fixed to the wall in a subcutaneous position using 3/0 polyglactin sutures. The limb between the hepaticojejunal anastomosis and the subcutaneous fixation should be short and straight.

Four Ligaclips are used to mark the jejunal loop by clipping the sutures holding the access loop in place.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

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Study Contact Backup

  • Name: Faculty of Medicine-Assiut University -Assiut-Egypt Faculty of Medicine-Assiut University -Assiut-Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients who will undergo roux-en-Y hepaticojejunostomy reconstruction at General surgery department - Assiut University.

Exclusion Criteria:

  • Patients with malignant disease necessitating roux-en-Y hepaticojejunostomy (Cholangiocarcinoma or inoperable pancreatic cancer) will be excluded from this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A
Patients undergoing modified hepaticojejunostomy with gastric access loop
Procedure: modified hepaticojejunostomy with gastric access loop
  • In the gastric access loop, the same steps are done for performing roux-en-Y hepaticojejunostomy.The end of the Roux jejunal loop taken up for hepaticojejunostomy is not closed but is anastomosed to the anterior wall of the gastric antrum near the pyloric orifice.
  • All the enterogastrostomies and enteroenterostomies were in the form of single-layer continuous sutures of polyglactin of 3-0 size. An intraperitoneal drain was left in the hepatorenal pouch before closing the incision.
Experimental: Group B:
Patients undergoing modified hepaticojejunostomy with subcutaneous access loop
Procedure: modified hepaticojejunostomy with subcutaneous access loop

In the subcutaneous access loop, the same steps are done for performing roux-en-Y hepaticojejunostomy.

The closed free end of roux loop is passed through the anterior abdominal wall in the right subcostal area and then fixed to the wall in a subcutaneous position using 3/0 polyglactin sutures. The limb between the hepaticojejunal anastomosis and the subcutaneous fixation should be short and straight.

Four Ligaclips are used to mark the jejunal loop by clipping the sutures holding the access loop in place.
Experimental: Group C:
Group C: Patients undergoing standard hepaticojejunostomy with no endoscopic access loop
Procedure: hepaticojejunostomy
  • Under general intubation anesthesia, a generous right subcostal incision is performed and could be extended on demand upward to the xiphoid process and/or to the left subcostal area. Thorough dissection and adhesiolysis is performed to reach the CBD and prepare the unaffected proximal part for anastomosis. The Roux jejunal loop is prepared and passed retrocolic to reach the porta hepatis.
  • Then, the hepaticojejunostomy is done via end to side anastomosis using interrupted sutures of polyglactin of 3-0 or 4-0 size. The anastomosis is done 10-15 cm away from the free distal end of the Roux jejunum loop to allow anastomosis without tension to the stomach. A biliary stent may be optionally placed according to operative circumstances and is brought out through the anterior abdominal wall.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
endoscopic access
Time Frame: first trial after 2 months (8 weeks) and second trial one year postoperatively
two trial of endoscopic entry for assessment of hepaticojejunostomy after 2 months (8 weeks) and one year postoperatively
first trial after 2 months (8 weeks) and second trial one year postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
mortality rate
Time Frame: up to 3 months postoperative for each case
number of deaths intraoperative and postoperative related to surgery
up to 3 months postoperative for each case
bilio-enteric fistula
Time Frame: 1 month post-operative for each case, data will be available
anastomotic leak from hepaticojejunostomy or enteroenterostomy
1 month post-operative for each case, data will be available
hepaticojejunostomy stricture
Time Frame: 6 months after the last case

stricture at anastomotic site of hepaticojejunostomy that may occur at any time during the study and detected by development of obstructive jaundice If obstructive jaundice, biliary pain or cholangitis subsequently developed, abdominal ultrasonography followed by MRCP is then carried out. Thereafter, endoscopic assessment of the hepaticojejunostomy was done either by upper endoscopy in Group A or through skin incision and gastroendoscope or choledochoscope in Group B.

Patients were reviewed 6 weeks after surgery, at 3-month intervals thereafter for the first year, and at 6-month intervals thereafter, unless they became symptomatic again.
6 months after the last case

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RF2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

All patients will be tested for liver functions tests and abdominal ultrasonography at the end of the 2nd post-operative week.

All patients of Group A and B will undergo trial of endoscopic assessment after 2 months (8 weeks) and one year postoperatively.

If obstructive jaundice, biliary pain or cholangitis subsequently developed, abdominal ultrasonography followed by MRCP is then carried out. Thereafter, endoscopic assessment of the hepaticojejunostomy was done either by upper endoscopy in Group A or through skin incision and gastroendoscope or choledochoscope in Group B.

Patients were reviewed 6 weeks after surgery, at 3-month intervals thereafter for the first year, and at 6-month intervals thereafter, unless they became symptomatic again.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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