Clinical trial NCT04289831: Preoperative Biliary Drainage in Patients With Operable Malignant Periampulary Tumors
Official title: "Impact of Preoperative Biliary Drainage on Surgical and Oncologic Outcomes After Pancreatico-Duodenectomy in Patients With Operable Malignant Periampulary Tumors. A Randomized Controlled Study"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periampullary Cancer
Biliary Obstruction
Preoperative Biliary Drainage
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Early postoperative mortality (within 3 months)
timeFrame: within 90 days after surgery
measure: Early postoperative morbidities (within 3 months)
timeFrame: within 90 days after surgery
Secondary outcomes:
measure: Tumor recurrence
timeFrame: 2 years follow up after surgery
measure: Disease free survival (DFS)
timeFrame: 2 years follow up after surgery
measure: Overall survival (OS)
timeFrame: 2 years follow up after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Ass. Professor of Surgery (Surgical Oncology Unit)
name: Mohamed M Elmessiry, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of Internal Medicine (Gastroenterology Unit)
name: Eman A Mohamed, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.