Preoperative Biliary Drainage in Patients With Operable Malignant Periampulary Tumors

"Impact of Preoperative Biliary Drainage on Surgical and Oncologic Outcomes After Pancreatico-Duodenectomy in Patients With Operable Malignant Periampulary Tumors. A Randomized Controlled Study"

The impact of preoperative biliary drainage (PBD) on morbidity and mortality associated with Pancreaticoduodenectomy (PD) in patients with peri-ampulary tumors is still controversial. The objective of this study is to evaluate the impact of PBD on surgical and oncologic outcomes after PD in jaundiced patients with operable peri-ampulary tumors.

Study Overview

• Status: Completed
• Conditions: Periampullary Cancer; Biliary Obstruction; Preoperative Biliary Drainage
• Intervention / Treatment: Procedure: Surgery; Procedure: Preoperative Biliary Drainage (PBD)

Detailed Description

150 consecutive jaundiced patients with suspected operable peri-ampullary tumors were randomized via concealed envelopes into 2 groups (each included 75 patients), group I managed by direct surgery while group II managed by PBD followed by surgery. Both groups were compared regarding perioperative mortality, morbidities, tumor recurrence and 2 years survival rates.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Serum bilirubin level above 4 mg/dl
• suspected peri-ampullary tumor at computed tomography (CT)
• No evidence of distant metastasis or locally advanced tumor

Exclusion Criteria:

• Patients with evidence of distant metastasis or locally advanced tumor
• Prior neoadjuvant chemotherapy or Radiotherapy
• Prior biliary surgery
• Patients with contraindication for major surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Direct Surgery (DS) group; patients subjected to direct surgery (DS) within 1 week after randomization	Procedure: Surgery; The standard surgical procedure for operable tumors Whipple procedure with triple reconstruction, namely pancreatogastrostomy or pancreatojejunostomy,hepaticojejunostomy and gastrojejunostomy
Active Comparator: Preoperative Biliary Drainage (PBD) group; patients managed by Preoperative Biliary Drainage followed by surgery after 4-6 weeks.	Procedure: Surgery; The standard surgical procedure for operable tumors Whipple procedure with triple reconstruction, namely pancreatogastrostomy or pancreatojejunostomy,hepaticojejunostomy and gastrojejunostomy; Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early postoperative mortality (within 3 months)	Death within 90 days postoperatively	within 90 days after surgery
Early postoperative morbidities (within 3 months)	Any complications related to surgery within 3 months including: postoperative bleeding, pancreatic fistula, Biliary leakage, Intra-abdominal infection, wound infection/ dehiscence	within 90 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor recurrence	Local or systemic recurrence of the malignant tumor	2 years follow up after surgery
Disease free survival (DFS)	% of patients survived without any evidence of tumor recurrence after 2 years follow up	2 years follow up after surgery
Overall survival (OS)	% of patients survived with or without tumor recurrence after 2 years follow up	2 years follow up after surgery

Collaborators and Investigators

• Sponsor: University of Alexandria
• Investigators: Principal Investigator: Mohamed M Elmessiry, MD,PhD, Ass. Professor of Surgery (Surgical Oncology Unit); Principal Investigator: Eman A Mohamed, MD, PhD, Lecturer of Internal Medicine (Gastroenterology Unit)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 27, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 03027612

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No