Preoperative Biliary Drainage in Patients With Operable Malignant Periampulary Tumors
NCT ID: NCT04289831
Last Updated: 2020-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2015-08-31
2019-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Direct Surgery (DS) group
patients subjected to direct surgery (DS) within 1 week after randomization
Surgery
The standard surgical procedure for operable tumors Whipple procedure with triple reconstruction, namely pancreatogastrostomy or pancreatojejunostomy,hepaticojejunostomy and gastrojejunostomy
Preoperative Biliary Drainage (PBD) group
patients managed by Preoperative Biliary Drainage followed by surgery after 4-6 weeks.
Preoperative Biliary Drainage (PBD)
Endoscopic retrograde biliary drainage (ERBD) and stent placement was the first choice for PBD while ultrasound-guided percutaneous transhepatic biliary drainage (PTBD) was done if ERBD was not feasible. Biliary drainage was considered successful if the serum bilirubin level decreased by 50% or more within 2 weeks after the procedure. Patients with failed PBD were referred directly to surgery, while those with successful PBD were referred to surgery 4 to 6 weeks after first drainage procedure according to the latest guidelines
Surgery
The standard surgical procedure for operable tumors Whipple procedure with triple reconstruction, namely pancreatogastrostomy or pancreatojejunostomy,hepaticojejunostomy and gastrojejunostomy
Interventions
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Preoperative Biliary Drainage (PBD)
Endoscopic retrograde biliary drainage (ERBD) and stent placement was the first choice for PBD while ultrasound-guided percutaneous transhepatic biliary drainage (PTBD) was done if ERBD was not feasible. Biliary drainage was considered successful if the serum bilirubin level decreased by 50% or more within 2 weeks after the procedure. Patients with failed PBD were referred directly to surgery, while those with successful PBD were referred to surgery 4 to 6 weeks after first drainage procedure according to the latest guidelines
Surgery
The standard surgical procedure for operable tumors Whipple procedure with triple reconstruction, namely pancreatogastrostomy or pancreatojejunostomy,hepaticojejunostomy and gastrojejunostomy
Eligibility Criteria
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Inclusion Criteria
* suspected peri-ampullary tumor at computed tomography (CT)
* No evidence of distant metastasis or locally advanced tumor
Exclusion Criteria
* Prior neoadjuvant chemotherapy or Radiotherapy
* Prior biliary surgery
* Patients with contraindication for major surgery
18 Years
70 Years
ALL
No
Sponsors
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University of Alexandria
OTHER
Responsible Party
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Mohamed El Messiry
Ass. Professor
Principal Investigators
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Mohamed M Elmessiry, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Ass. Professor of Surgery (Surgical Oncology Unit)
Eman A Mohamed, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Lecturer of Internal Medicine (Gastroenterology Unit)
References
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Wang C, Xu Y, Lu X. Should preoperative biliary drainage be routinely performed for obstructive jaundice with resectable tumor? Hepatobiliary Surg Nutr. 2013 Oct;2(5):266-71. doi: 10.3978/j.issn.2304-3881.2013.09.01.
Mezhir JJ, Brennan MF, Baser RE, D'Angelica MI, Fong Y, DeMatteo RP, Jarnagin WR, Allen PJ. A matched case-control study of preoperative biliary drainage in patients with pancreatic adenocarcinoma: routine drainage is not justified. J Gastrointest Surg. 2009 Dec;13(12):2163-9. doi: 10.1007/s11605-009-1046-9. Epub 2009 Sep 23.
Smith RA, Dajani K, Dodd S, Whelan P, Raraty M, Sutton R, Campbell F, Neoptolemos JP, Ghaneh P. Preoperative resolution of jaundice following biliary stenting predicts more favourable early survival in resected pancreatic ductal adenocarcinoma. Ann Surg Oncol. 2008 Nov;15(11):3138-46. doi: 10.1245/s10434-008-0148-z. Epub 2008 Sep 12.
Abdullah SA, Gupta T, Jaafar KA, Chung YF, Ooi LL, Mesenas SJ. Ampullary carcinoma: effect of preoperative biliary drainage on surgical outcome. World J Gastroenterol. 2009 Jun 21;15(23):2908-12. doi: 10.3748/wjg.15.2908.
Other Identifiers
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03027612
Identifier Type: -
Identifier Source: org_study_id