PANasta Trial: Cattell Warren versus Blumgart techniques of pancreatico-jejunostomy following pancreato-duodenectomy—A double-blinded multi-centered trial, trial results.

Abstract

4619 Background: Pancreatic anastomosis failure following pancreatic head excision, for suspected pancreatic cancer, leads to longer recovery and failure to start or complete adjuvant chemotherapy. The aim of this study is to evaluate whether a Blumgart anastomosis (BA) reduces the post operative pancreatic fistula (POPF) rate compared to a more traditional Cattell-Warren anastomosis (CWA). Methods: Patients with suspected pancreatic cancer, undergoing elective pancreato-duodenectomy were randomized intra-operatively to either a BA or a CWA. Anastomoses were constructed according to prior agreed techniques and an operative manual describing key surgical steps. Quality control of these key steps and adherence to the arm of randomization was ensured by operative photographs. Surgical drain amylase was measured post-operatively to establish the primary end point of POPF. These were graded A (biochemical) or B and C (clinically relevant, CR-POPF). Secondary endpoints included: Entry in adjuvant therapy, hospital stay, mortality and survival. Overall survival was estimated using the method of Kaplan Meier and defined as the time from randomisation until death by any cause with alive patients censored at the end of study date. Results: Between May 5 2015 and August 7 2017, 238 patients were randomized, 2 patients withdrew, leaving 236 patients for analysis (112 BA, 124 CWA). Median age was 70 years, 63% were men. Median time from diagnosis to randomization (surgery) was 33 days for both arms. In the BA arm there were 28 POPF’s (15-A, 10-B and 3-C) and 32 in the CWA arm (18-A, 12-B and 2-C), p = 0.887. In total 27 patients (11.4%) developed a CR-POPF, BA 13 (5.5%), CWA 14 (5.9%), p = 0.857. 75% of eligible patients entered chemotherapy, with a median (IQR) time to the start treatment of 2.55 (2.27, 3.15) months for the BA group and 2.87 (2.56, 3.75) for the CWA group. Median hospital stay (IQR) in days was 13 (10-24) for BA and 14.5 (10-22) for CWA, p = 0.232. The overall surgical related mortally at 90 days was 1.7%. 44 study deaths were observed, 35 were due to disease progression (BA 19, CWA 16). A hazard ratio (95% CI) of 0.72 (0.4, 1.311) shows better, but not statistically significant survival for the CWA group. Conclusions: This is the largest surgical trial ever conducted comparing these techniques and there was no significant difference in the POPF rate between the BA and CWA anastomoses. In a UK population the clinically relevant POPF rate is 11% and 75% of eligible patients enter chemotherapy. Clinical trial information: ISRCTN52263879 .