NCT03252379

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

Status unknown NA Last updated 18 August 2017

What this trial tests

NA trial testing hepaticojejunostomy in Jaundice, Obstructive in 30 participants. Status unknown.

Timeline

1 September 2017

Primary endpoint
1 December 2019

30 December 2019

Quick facts

Lead sponsor	Assiut University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	30
Start date	1 September 2017
Primary completion	1 December 2019
Estimated completion	30 December 2019

Drugs / interventions tested

• hepaticojejunostomy
• modified hepaticojejunostomy with subcutaneous access loop
• modified hepaticojejunostomy with gastric access loop

Conditions studied

• Jaundice, Obstructive — all drugs for Jaundice, Obstructive →

Sponsor

Assiut University

Who can join

Adults 18 to 80, any sex, with Jaundice, Obstructive. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Hepaticojejunostomy with gastric access loop versus conventional hepaticojejunostomy: a randomized trial.
   Raafat M, Morsy MM, Mohamed SI, Hamad MA, et al · · 2023 · PMID 37556078 · DOI 10.1007/s13304-023-01604-6