Preoperative Biliary Drainage in Patients With Operable Malignant Periampulary Tumors

NCT04289831 | Completed DMC

• 1 other identifier: 03027612
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Periampullary Cancer; Biliary Obstruction; Preoperative Biliary Drainage

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Tumor recurrence

  2 years follow up after surgery

• Disease free survival (DFS)

  2 years follow up after surgery

• Overall survival (OS)

  2 years follow up after surgery

Study Arms (2)

Direct Surgery (DS) group

ACTIVE COMPARATOR

patients subjected to direct surgery (DS) within 1 week after randomization

Procedure: Surgery

Preoperative Biliary Drainage (PBD) group

ACTIVE COMPARATOR

patients managed by Preoperative Biliary Drainage followed by surgery after 4-6 weeks.

Procedure: Preoperative Biliary Drainage (PBD); Procedure: Surgery

Interventions

Preoperative Biliary Drainage (PBD) PROCEDURE

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

Preoperative Biliary Drainage (PBD) group

Surgery PROCEDURE

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

Direct Surgery (DS) group; Preoperative Biliary Drainage (PBD) group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alexandria: lead

Related Publications (4)

• 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.

  PMID: 24570957 BACKGROUND

• 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.

  PMID: 19774424 BACKGROUND

• 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.

  PMID: 18787902 BACKGROUND

• 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.

  PMID: 19533815 BACKGROUND

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Professor

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: February 28, 2020
• Study Start: August 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2019
• Last Updated: February 28, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share