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Impact of Prior Biliary Drainage With Plastic Stents on the Performance of Self-Expanding Metal Stents in Patients Receiving Neoadjuvant Therapy for Pancreatic Cancer
Brian Ginnebaugh*3, Kathryn R. Byrne1, Darren D. Ballard1, Nishchal Kumar1, Susan Tsai2, Douglas B. Evans2, Kulwinder S. Dua1
1Gastroenterology and Hepatology, Medical College of Wisconsin, Milwaukee, WI; 2Surgery, Medical College of Wisconsin, Milwaukee, WI; 3Internal Medicine, Medical College of Wisconsin, Milwaukee, WI
Introduction: Increasing numbers of patients with resectable pancreas cancer (RPC) are receiving pre-operative neoadjuvant therapy for 3 to 4 months. Self-expanding metal stents (SEMS) provide more durable biliary drainage compared to plastic stents (PS). Due to lack of tissue diagnosis secondary to limited availability of EUS/FNA and/or on-site cytophathologist, biliary obstructions are often drained by PS at the index ERCP. These patients are then referred to tertiary centers for tissue diagnosis and, if positive, the PS are exchanged to SEMS.
Aim: Evaluate the impact of prior biliary drainage with PS on the performance of SEMS in patients receiving neoadjuvant therapy for RPC.
Methods: From 2011 to 2013, all consecutive patients with biliary obstruction secondary to pancreas cancer referred to one tertiary center were reviewed using a prospectively collected database. Outside hospital records were also reviewed. Patients underwent staging CT/MRI scan and those with RPC were enrolled in the study. All patients underwent EUS/FNA with immediate cytology evaluation by an on-site cytopathologist. If positive for cancer, during the same procedure, the previously placed PS was changed to a SEMS in those with prior biliary intervention or upfront a SEMS was placed in those without prior intervention. All patients received neoadjuvant therapy. Data on demographics, stent patency, complications and re-intervention rates was prospectively collected and compared between the two groups.
Results: Seventy-seven patients were enrolled in the study. At index ERCP, 53 patients underwent biliary drainage with PS at an outside hospital. Nine (17%) of these patients had complications (cholangitis, PS occlusion and migration). Upfront SEMS were placed in 24 patients following a positive on-site EUS/FNA cytology at the tertiary center (Table 1). Prior to neoadjuvant therapy, all PS were exchanged to SEMS following a positive cytology. The median duration of neoadjuvant therapy was similar between the two groups (Table 2). During this period, 4 of 53 SEMS (8%) malfunctioned at a median of 36 days (range 12- 86) after insertion in the prior PS group compared to 1 of 24 (4%) at day 10 in the upfront SEMS group (p=0.9). All SEMS malfunctions (sludge, tissue in-growth) were successfully managed by repeat ERCP.
Conclusion: During neoadjuvant therapy for resectable pancreas cancer, previous biliary drainage with plastic stents does not adversely affect the performance of subsequently placed self-expandable metal stents as compared to those drained with metal stents upfront. Since ERCP is associated with complications and malignant biliary obstruction rarely leads to cholangitis, it is recommended not to do ERCP with placement of a plastic stent due to non-availability of EUS/FNA and/or on-site cytology. This also saves the patient having multiple procedures.
Table 1: Patient characteristics
| Prior plastic stent exchanged to metal stent | Upfront self-expandable metal stent | p value | | N | 53 | 24 | - | Age (yrs)
(gender) | 68 ± 10 SD
(M 26 F 27) | 65 ± 9 SD
(M 14 F 10) | NS | | Resectable tumor (n) | 25 (47%) | 14 (58%) | NS | | Borderline resectable (n) | 28 (53%) | 11 (42%) | NS |
Table 2: Outcomes | Prior plastic stent exchanged to metal stent
N=53 | Upfront self-expandable metal stent
N=24 | p value | Duration of neoadjuvant therapy
Median in days (range) | 91
(74-112) | 100
(52-148) | 0.8 | | Metal stent dysfunction during neoadjuvant therapy (n) | 4 (8%) | 1 (4%) | 0.9 |
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