Endoscopic Access Loop With Bilio-enteric Anastomosis: A Prospective Randomized Comparison Between Gastric and Subcutaneous Accesses
Primary Purpose
Jaundice, Obstructive
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
hepaticojejunostomy
modified hepaticojejunostomy with subcutaneous access loop
modified hepaticojejunostomy with gastric access loop
Sponsored by
About this trial
This is an interventional treatment trial for Jaundice, Obstructive
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group A
Group B:
Group C:
Arm Description
Patients undergoing modified hepaticojejunostomy with gastric access loop
Patients undergoing modified hepaticojejunostomy with subcutaneous access loop
Group C: Patients undergoing standard hepaticojejunostomy with no endoscopic access loop
Outcomes
Primary Outcome Measures
endoscopic access
two trial of endoscopic entry for assessment of hepaticojejunostomy after 2 months (8 weeks) and one year postoperatively
Secondary Outcome Measures
mortality rate
number of deaths intraoperative and postoperative related to surgery
bilio-enteric fistula
anastomotic leak from hepaticojejunostomy or enteroenterostomy
hepaticojejunostomy stricture
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03252379
Brief Title
Endoscopic Access Loop With Bilio-enteric Anastomosis: A Prospective Randomized Comparison Between Gastric and Subcutaneous Accesses
Official Title
Endoscopic Access Loop With Bilio-enteric Anastomosis: A Prospective Randomized Comparison Between Gastric and Subcutaneous Accesses
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Anticipated)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaundice, Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Patients undergoing modified hepaticojejunostomy with gastric access loop
Arm Title
Group B:
Arm Type
Experimental
Arm Description
Patients undergoing modified hepaticojejunostomy with subcutaneous access loop
Arm Title
Group C:
Arm Type
Experimental
Arm Description
Group C: Patients undergoing standard hepaticojejunostomy with no endoscopic access loop
Intervention Type
Procedure
Intervention Name(s)
hepaticojejunostomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
modified hepaticojejunostomy with subcutaneous access loop
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
modified hepaticojejunostomy with gastric access loop
Intervention Description
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.
Primary Outcome Measure Information:
Title
endoscopic access
Description
two trial of endoscopic entry for assessment of hepaticojejunostomy after 2 months (8 weeks) and one year postoperatively
Time Frame
first trial after 2 months (8 weeks) and second trial one year postoperatively
Secondary Outcome Measure Information:
Title
mortality rate
Description
number of deaths intraoperative and postoperative related to surgery
Time Frame
up to 3 months postoperative for each case
Title
bilio-enteric fistula
Description
anastomotic leak from hepaticojejunostomy or enteroenterostomy
Time Frame
1 month post-operative for each case, data will be available
Title
hepaticojejunostomy stricture
Description
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.
Time Frame
6 months after the last case
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamad Raafat, MSc
Phone
0201067877622
Email
mohamad_raafat10@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Faculty of Medicine-Assiut University -Assiut-Egypt Faculty of Medicine-Assiut University -Assiut-Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing 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.
Citations:
PubMed Identifier
7575127
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
8452402
Citation
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.
Results Reference
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PubMed Identifier
12832970
Citation
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Results Reference
background
PubMed Identifier
12146986
Citation
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.
Results Reference
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Citation
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.
Results Reference
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Citation
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.
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Endoscopic Access Loop With Bilio-enteric Anastomosis: A Prospective Randomized Comparison Between Gastric and Subcutaneous Accesses
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