Jaundice, ObstructiveNCT03252379
Endoscopic Access Loop With Bilio-enteric Anastomosis: A Prospective Randomized Comparison Between Gastric and Subcutaneous Accesses
A study testing hepaticojejunostomy, modified hepaticojejunostomy with subcutaneous access loop and modified hepaticojejunostomy with gastric access loop in people with Jaundice, Obstructive, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Jaundice, Obstructive
- What is being tested?
- hepaticojejunostomy, modified hepaticojejunostomy with subcutaneous access loop and modified hepaticojejunostomy with gastric access loop
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2017to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who will undergo roux-en-Y hepaticojejunostomy reconstruction at General surgery department - Assiut University.
Who cannot join
- Patients with malignant disease necessitating roux-en-Y hepaticojejunostomy (Cholangiocarcinoma or inoperable pancreatic cancer) will be excluded from this study.
Trial locations and contacts
No sites are listed yet.
Faculty of Medicine-Assiut University -Assiut-Egypt Faculty of Medicine-Assiut University -Assiut-Egypt contact
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Jaundice, Obstructive
- Being tested
- hepaticojejunostomy, modified hepaticojejunostomy with subcutaneous access loop, modified hepaticojejunostomy with gastric access loop
- Medical subject headings
- Jaundice, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepaticojejunostomyProcedure or surgery
- 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 loopProcedure or surgery
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 loopProcedure or surgery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients undergoing modified hepaticojejunostomy with gastric access loop Receives: Procedure: modified hepaticojejunostomy with gastric access loop |
| Group B: | Experimental | Patients undergoing modified hepaticojejunostomy with subcutaneous access loop Receives: Procedure: modified hepaticojejunostomy with subcutaneous access loop |
| Group C: | Experimental | Group C: Patients undergoing standard hepaticojejunostomy with no endoscopic access loop Receives: Procedure: hepaticojejunostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
endoscopic access
two trial of endoscopic entry for assessment of hepaticojejunostomy after 2 months (8 weeks) and one year postoperatively
Measured: first trial after 2 months (8 weeks) and second trial one year postoperatively
Secondary outcomes (3)
mortality rate
number of deaths intraoperative and postoperative related to surgery
Measured: up to 3 months postoperative for each case
bilio-enteric fistula
anastomotic leak from hepaticojejunostomy or enteroenterostomy
Measured: 1 month post-operative for each case, data will be available
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.
Measured: 6 months after the last case
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start1 Sep 2017 (estimated)
- Primary completion1 Dec 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Jaundice, ObstructiveStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamad Raafat, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252379
- Sponsor's protocol ID
- RF2017
- Status last verified
- Aug 2017
- First submitted
- 12 Aug 2017
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 7575127Csendes 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.
PubMed 11596901Davids 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.
PubMed 8452402Alves 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.
PubMed 12832970Moraca 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.
PubMed 12146986Rothlin 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.
PubMed 9445233Tocchi 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.
PubMed 8757379Lillemoe 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.
PubMed 10973393Raafat 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.
PubMed 37556078
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Access Loop With Bilio-enteric Anastomosis: A Prospective Randomized Comparison Between Gastric and Subcutaneous Accesses
- ClinicalTrials.gov ID
- NCT03252379
- Acronym / sponsor ID
- RF2017
- Conditions
- Jaundice, Obstructive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 17 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: modified hepaticojejunostomy with gastric access loopPatients undergoing modified hepaticojejunostomy with gastric access loop |
| Group B: | Experimental | Procedure: modified hepaticojejunostomy with subcutaneous access loopPatients undergoing modified hepaticojejunostomy with subcutaneous access loop |
| Group C: | Experimental | Procedure: hepaticojejunostomyGroup C: Patients undergoing standard hepaticojejunostomy with no endoscopic access loop |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who will undergo roux-en-Y hepaticojejunostomy reconstruction at General surgery department - Assiut University.
Key exclusion criteria (1 listed)
- Patients with malignant disease necessitating roux-en-Y hepaticojejunostomy (Cholangiocarcinoma or inoperable pancreatic cancer) will be excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Group C: |
| modified hepaticojejunostomy with subcutaneous access loopIn 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. | Procedure or surgery | Group B: |
| 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. | Procedure or surgery | Group A |
Primary outcome
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
3 secondary outcomes
mortality rate
Time frame: up to 3 months postoperative for each case
bilio-enteric fistula
Time frame: 1 month post-operative for each case, data will be available
hepaticojejunostomy stricture
Time frame: 6 months after the last case
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
- Background: PubMed 7575127Stewart 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.
- Background: PubMed 11596901Csendes 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.
- Background: PubMed 8452402Davids 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.
- Background: PubMed 12832970Alves 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.
- Background: PubMed 12146986Moraca 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.
- Background: PubMed 9445233Rothlin 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.
- Background: PubMed 8757379Tocchi 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.
- Background: PubMed 10973393Lillemoe 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.
- Derived from this study: PubMed 37556078Raafat 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.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faculty of Medicine-Assiut University -Assiut-Egypt Faculty of Medicine-Assiut University -Assiut-Egypt contact
Questions about this trial
What is this clinical trial studying?
A study testing hepaticojejunostomy, modified hepaticojejunostomy with subcutaneous access loop and modified hepaticojejunostomy with gastric access loop in people with Jaundice, Obstructive, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamad Raafat, MSc (0201067877622, mohamad_raafat10@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endoscopic access (time frame: first trial after 2 months (8 weeks) and second trial one year postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03252379, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2017.