Endoscopic Access Loop With Bilio-enteric Anastomosis: A Prospective Randomized Comparison Between Gastric and Subcutaneous Accesses
NCT ID: NCT03252379
Last Updated: 2017-08-18
Study Results
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Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2017-09-01
2019-12-30
Brief Summary
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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.
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Detailed Description
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\* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* 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
TREATMENT
SINGLE
Study Groups
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Group A
Patients undergoing modified hepaticojejunostomy with gastric access loop
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.
Group B:
Patients undergoing modified hepaticojejunostomy with subcutaneous access loop
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.
Group C:
Group C: Patients undergoing standard hepaticojejunostomy with no endoscopic access loop
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Mohamad Raafat
Assistant lecturer at General surgery department
Central Contacts
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Faculty of Medicine-Assiut University -Assiut-Egypt Faculty of Medicine-Assiut University -Assiut-Egypt
Role: CONTACT
References
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Stewart L, Way LW. Bile duct injuries during laparoscopic cholecystectomy. Factors that influence the results of treatment. Arch Surg. 1995 Oct;130(10):1123-8; discussion 1129. doi: 10.1001/archsurg.1995.01430100101019.
Csendes A, Navarrete C, Burdiles P, Yarmuch J. Treatment of common bile duct injuries during laparoscopic cholecystectomy: endoscopic and surgical management. World J Surg. 2001 Oct;25(10):1346-51. doi: 10.1007/s00268-001-0121-5.
Davids PH, Tanka AK, Rauws EA, van Gulik TM, van Leeuwen DJ, de Wit LT, Verbeek PC, Huibregtse K, van der Heyde MN, Tytgat GN. Benign biliary strictures. Surgery or endoscopy? Ann Surg. 1993 Mar;217(3):237-43. doi: 10.1097/00000658-199303000-00004.
Alves A, Farges O, Nicolet J, Watrin T, Sauvanet A, Belghiti J. Incidence and consequence of an hepatic artery injury in patients with postcholecystectomy bile duct strictures. Ann Surg. 2003 Jul;238(1):93-6. doi: 10.1097/01.sla.0000074983.39297.c5.
Moraca RJ, Lee FT, Ryan JA Jr, Traverso LW. Long-term biliary function after reconstruction of major bile duct injuries with hepaticoduodenostomy or hepaticojejunostomy. Arch Surg. 2002 Aug;137(8):889-93; discussion 893-4. doi: 10.1001/archsurg.137.8.889.
Rothlin MA, Lopfe M, Schlumpf R, Largiader F. Long-term results of hepaticojejunostomy for benign lesions of the bile ducts. Am J Surg. 1998 Jan;175(1):22-6. doi: 10.1016/s0002-9610(97)00229-8.
Tocchi A, Costa G, Lepre L, Liotta G, Mazzoni G, Sita A. The long-term outcome of hepaticojejunostomy in the treatment of benign bile duct strictures. Ann Surg. 1996 Aug;224(2):162-7. doi: 10.1097/00000658-199608000-00008.
Lillemoe KD, Melton GB, Cameron JL, Pitt HA, Campbell KA, Talamini MA, Sauter PA, Coleman J, Yeo CJ. Postoperative bile duct strictures: management and outcome in the 1990s. Ann Surg. 2000 Sep;232(3):430-41. doi: 10.1097/00000658-200009000-00015.
Raafat M, Morsy MM, Mohamed SI, Hamad MA, Sayed MM. Hepaticojejunostomy with gastric access loop versus conventional hepaticojejunostomy: a randomized trial. Updates Surg. 2023 Dec;75(8):2157-2167. doi: 10.1007/s13304-023-01604-6. Epub 2023 Aug 9.
Other Identifiers
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RF2017
Identifier Type: -
Identifier Source: org_study_id
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