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

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ClinicalTrials.gov Identifier: NCT03252379
Recruitment Status : Not yet recruiting
First Posted : August 17, 2017
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):
Mohamad Raafat, Assiut University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Jaundice, Obstructive Procedure: hepaticojejunostomy Procedure: modified hepaticojejunostomy with subcutaneous access loop Procedure: modified hepaticojejunostomy with gastric access loop Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Endoscopic Access Loop With Bilio-enteric Anastomosis: A Prospective Randomized Comparison Between Gastric and Subcutaneous Accesses
Estimated Study Start Date : September 1, 2017
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. mortality rate [ Time Frame: up to 3 months postoperative for each case ]
    number of deaths intraoperative and postoperative related to surgery

  2. bilio-enteric fistula [ Time Frame: 1 month post-operative for each case, data will be available ]
    anastomotic leak from hepaticojejunostomy or enteroenterostomy

  3. 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.




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03252379


Contacts
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Contact: Mohamad Raafat, MSc 0201067877622 mohamad_raafat10@yahoo.com
Contact: Faculty of Medicine-Assiut University -Assiut-Egypt Faculty of Medicine-Assiut University -Assiut-Egypt

Sponsors and Collaborators
Assiut University

Publications:

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Responsible Party: Mohamad Raafat, Assistant lecturer at General surgery department, Assiut University
ClinicalTrials.gov Identifier: NCT03252379     History of Changes
Other Study ID Numbers: RF2017
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Jaundice
Jaundice, Obstructive
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms