Preoperative Biliary Drainage in Patients With Operable Malignant Periampulary Tumors

Biliary Obstruction Clinical Trial

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04289831
• Other study ID #: 03027612
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: October 2019

Study information

• Verified date: February 2020
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2019
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Biliary Obstruction
• Periampullary Cancer
• Preoperative Biliary Drainage

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alexandria

References & Publications (4)

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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early postoperative mortality (within 3 months)	Death within 90 days postoperatively	within 90 days after surgery
Primary	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	Tumor recurrence	Local or systemic recurrence of the malignant tumor	2 years follow up after surgery
Secondary	Disease free survival (DFS)	% of patients survived without any evidence of tumor recurrence after 2 years follow up	2 years follow up after surgery
Secondary	Overall survival (OS)	% of patients survived with or without tumor recurrence after 2 years follow up	2 years follow up after surgery