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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct Surgery (DS) group | Active Comparator | patients subjected to direct surgery (DS) within 1 week after randomization |
|
| Preoperative Biliary Drainage (PBD) group | Active Comparator | patients managed by Preoperative Biliary Drainage followed by surgery after 4-6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24570957 | Background | 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. | |
| 19774424 | 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. |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Surgery | Procedure | The standard surgical procedure for operable tumors Whipple procedure with triple reconstruction, namely pancreatogastrostomy or pancreatojejunostomy,hepaticojejunostomy and gastrojejunostomy |
|
| 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 |
| 18787902 | 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. |
| 19533815 | 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. |