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CompletedNCT04289831Updated Feb 28, 2020

Preoperative Biliary Drainage in Patients With Operable Malignant Periampulary Tumors

An interventional study of Preoperative Biliary Drainage (PBD) and Surgery in Periampullary Cancer, Biliary Obstruction and Preoperative Biliary Drainage, sponsored by University of Alexandria. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-02-28.

Sponsored by University of Alexandria · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 6 months after the study started (first participant enrolled Aug 2015, registered Feb 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Periampullary Cancer
  • Biliary Obstruction
  • Preoperative Biliary Drainage
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In context

Lead sponsor

University of Alexandria is the lead sponsor of 57 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
150 participants (actual)

Study arms

  • Active comparator
    Direct Surgery (DS) group

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

    Procedure: Surgery

  • 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) · Procedure: Surgery

Interventions

  • ProcedurePreoperative 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

  • ProcedureSurgery

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

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What researchers measure

Primary outcomes

  1. Early postoperative mortality (within 3 months)

    Death within 90 days postoperatively

    Time frame: within 90 days after surgery

  2. 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

    Time frame: within 90 days after surgery

Secondary outcomes

  1. Tumor recurrence

    Local or systemic recurrence of the malignant tumor

    Time frame: 2 years follow up after surgery

  2. Disease free survival (DFS)

    % of patients survived without any evidence of tumor recurrence after 2 years follow up

    Time frame: 2 years follow up after surgery

  3. Overall survival (OS)

    % of patients survived with or without tumor recurrence after 2 years follow up

    Time frame: 2 years follow up after surgery

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Study locations

No study locations are listed for this record.

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References and documents

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. PubMed 24570957 ↗
  • 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. PubMed 19774424 ↗
  • 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. PubMed 18787902 ↗
  • 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. PubMed 19533815 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04289831
Lead sponsor
University of Alexandria
Responsible party
Mohamed El Messiry (Ass. Professor, University of Alexandria) — Principal investigator
First posted
Feb 28, 2020
Start date
Aug 2015
Primary completion
Oct 2017
Completion
Oct 2019
Last update
Feb 28, 2020

Study contacts

Mohamed M Elmessiry, MD,PhD
principal investigator · Ass. Professor of Surgery (Surgical Oncology Unit)
Eman A Mohamed, MD, PhD
principal investigator · Lecturer of Internal Medicine (Gastroenterology Unit)

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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