Preoperative Biliary Drainage In Patients With Operable Malignant Periampulary Tumors

Study Overview

Preoperative Biliary Drainage in Patients With Operable Malignant Periampulary Tumors

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.

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.

Periampullary Cancer
Biliary Obstruction
Preoperative Biliary Drainage

PROCEDURE: Preoperative Biliary Drainage (PBD)
PROCEDURE: Surgery

03027612

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-02-27	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-02-27
First Submitted that Met QC Criteria 2020-02-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-02-28
First Posted (ACTUAL) 2020-02-28	Results First Posted N/A	Last Verified 2020-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Double

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: 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 s PROCEDURE: Surgery The standard surgical procedure for operable tumors Whipple procedure with triple reconstruction, namely pancreatogastrostomy or pancreatojejunostomy,hepaticojejunostomy and gastrojejunostomy

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: 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 s

PROCEDURE: Surgery

The standard surgical procedure for operable tumors Whipple procedure with triple reconstruction, namely pancreatogastrostomy or pancreatojejunostomy,hepaticojejunostomy and gastrojejunostomy

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Mohamed M Elmessiry, MD,PhD, Ass. Professor of Surgery (Surgical Oncology Unit)

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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.

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