Axial slicing versus bivalving in the pathological examination of pancreatoduodenectomy specimens (APOLLO): a multicentre randomized controlled trial

Abstract

Background: In pancreatoduodenectomy specimens, dissection method may affect the assessment of primary tumour origin (i.e. pancreatic, distal bile duct or ampullary adenocarcinoma), which is primarily determined macroscopically. This is the first study to prospectively compare the two commonly used techniques, i.e. axial slicing and bivalving.Methods: In four centres, a randomized controlled trial was performed in specimens of patients with a suspected (pre)malignant tumour in the pancreatic head. Primary outcome measure was the level of certainty (scale 0-100) regarding tumour origin by four independent gastrointestinal pathologists based on macroscopic assessment. Secondary outcomes were inter-observer agreement and R1 rate.Results: In total, 128 pancreatoduodenectomy specimens were randomized. The level of certainty in determining the primary tumour origin did not differ between axial slicing and bivalving (mean score 72 [sd 13] vs. 68 [sd 16], p = 0.21), nor did inter-observer agreement, both being moderate (kappa 0.45 vs. 0.47). In pancreatic cancer specimens, R1 rate (60% vs. 55%, p = 0.71) and the number of harvested lymph nodes (median 16 vs. 17, p = 0.58) were similar. Conclusion:This study demonstrated no differences in determining the tumour origin between axial slicing and bivalving. Both techniques performed similarly regarding inter-observer agreement, R1 rate, and lymph node harvest.

The Feasibility, Proficiency, and Mastery Learning Curves in 635 Robotic Pancreatoduodenectomies Following A Multicenter Training Program

“…In the current study, the median number of 15 retrieved lymph nodes was similar to the 16 nodes retrieved in a recent Dutch multicenter randomized trial on PD specimen grossing 55 . Although this median number of 15 lymph nodes is 54 somewhat below a recent international benchmark cutoff (>16 nodes) 56 it is much lower than >28 required lymph nodes reported in a recent study 57 . The rate of R0 resection (>0 mm definition) was 81% in the current study, which conforms to textbook outcomes for pancreatic adenocarcinoma as identified from the National Cancer Database (>77.9%) 58 .…”

“…It is therefore likely that the progression of the experience came with a mitigation of the severity of the complications. During the LAELAPS-3 program, the Dutch PORSCH trial investigated whether the implementation of an algorithm for early detection and management of pancreatic fistula may improve outcomes after pancreatic resection and subsequently halved mortality after pancreatic surgery 54 . This intervention might have increased rate of postoperative fistula, due to increased use of percutaneous drainage, but may also have played a role in the decrease in grade C POPF to 0% after the “mastery” cutoff.…”

Pathologic Examination of Pancreatic Specimens Resected for Treated Pancreatic Ductal Adenocarcinoma

“…The working group agreed that both bivalving and axial sectioning approach may be used at the preference of the pathologist for pancreaticoduodenectomy specimens resected for PDAC after neoadjuvant therapy. Evolving literature indicates that both approaches provide comparable results, with their respective advantages and disadvantages 40. A multi-institutional, prospective study to compare the bivalving and axial sectioning approaches for pancreaticoduodenectomy specimens in the setting of neoadjuvant treatment is currently ongoing.…”

“…Evolving literature indicates that both approaches provide comparable results, with their respective advantages and disadvantages. 40 A multi-institutional, prospective study to compare the bivalving and axial sectioning approaches for pancreaticoduodenectomy specimens in the setting of neoadjuvant treatment is currently ongoing. Tumor size measurement is extremely difficult for PDAC after neoadjuvant therapy.…”

The Role of Pathological Method and Clearance Definition for the Evaluation of Margin Status after Pancreatoduodenectomy for Periampullary Cancer. Results of a Multicenter Prospective Randomized Trial

“…Moreover, the insignificant impact of the kind of pathological evaluation in terms of R1 rate reported in our study confirmed that reported by a recent randomized controlled trial published by the Dutch Pancreatic Cancer Group. In this study, bivalve and axial slicing of PD specimen were evaluated: the R1 rate was similar with the two slicing techniques (60% and 55%, respectively; p = 0.71) [ 30 ].…”