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

NCT03252379 | Unknown

• 1 other identifier: RF2017
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Jaundice, Obstructive

Outcome Measures

Primary Outcomes (1)

• endoscopic access

  two trial of endoscopic entry for assessment of hepaticojejunostomy after 2 months (8 weeks) and one year postoperatively

  first trial after 2 months (8 weeks) and second trial one year postoperatively

Secondary Outcomes (3)

• mortality rate

  up to 3 months postoperative for each case

• bilio-enteric fistula

  1 month post-operative for each case, data will be available

• hepaticojejunostomy stricture

  6 months after the last case

Study Arms (3)

Group A

EXPERIMENTAL

Patients undergoing modified hepaticojejunostomy with gastric access loop

Procedure: modified hepaticojejunostomy with gastric access loop

Group B:

EXPERIMENTAL

Patients undergoing modified hepaticojejunostomy with subcutaneous access loop

Procedure: modified hepaticojejunostomy with subcutaneous access loop

Group C:

EXPERIMENTAL

Group C: Patients undergoing standard hepaticojejunostomy with no endoscopic access loop

Procedure: hepaticojejunostomy

Interventions

hepaticojejunostomy PROCEDURE

* 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.

Group C:

modified hepaticojejunostomy with subcutaneous access loop PROCEDURE

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 B:

modified hepaticojejunostomy with gastric access loop PROCEDURE

* 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 A

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients who will undergo roux-en-Y hepaticojejunostomy reconstruction at General surgery department - Assiut University.

You may not qualify if:

• Patients with malignant disease necessitating roux-en-Y hepaticojejunostomy (Cholangiocarcinoma or inoperable pancreatic cancer) will be excluded from this study.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (9)

• 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.

  PMID: 7575127 BACKGROUND

• 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.

  PMID: 11596901 BACKGROUND

• 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.

  PMID: 8452402 BACKGROUND

• 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.

  PMID: 12832970 BACKGROUND

• 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.

  PMID: 12146986 BACKGROUND

• 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.

  PMID: 9445233 BACKGROUND

• 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.

  PMID: 8757379 BACKGROUND

• 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.

  PMID: 10973393 BACKGROUND

• 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.

  PMID: 37556078 DERIVED

MeSH Terms

Conditions

Jaundice, Obstructive

Condition Hierarchy (Ancestors)

Jaundice; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Central Study Contacts

Mohamad Raafat, MSc

CONTACT

0201067877622; mohamad_raafat10@yahoo.com

Faculty of Medicine-Assiut University -Assiut-Egypt Faculty of Medicine-Assiut University -Assiut-Egypt

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer at General surgery department

Model Details: 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

Study Record Dates

• First Submitted: August 12, 2017
• First Posted: August 17, 2017
• Study Start: September 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 30, 2019
• Last Updated: August 18, 2017

Record last verified: 2017-08