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
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Patients will be randomized into three groups according to the surgical procedure performed as follows:
|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|
Experimental: Group A
Patients undergoing modified hepaticojejunostomy with gastric access loop
Procedure: modified hepaticojejunostomy with gastric access loop
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
- 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
- mortality rate [ Time Frame: up to 3 months postoperative for each case ]number of deaths intraoperative and postoperative related to surgery
- bilio-enteric fistula [ Time Frame: 1 month post-operative for each case, data will be available ]anastomotic leak from hepaticojejunostomy or enteroenterostomy
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03252379
|Contact: Mohamad Raafat, MScfirstname.lastname@example.org|
|Contact: Faculty of Medicine-Assiut University -Assiut-Egypt Faculty of Medicine-Assiut University -Assiut-Egypt|