Staging laparoscopy to prevent non-therapeutic laparotomy after neoadjuvant treatment for pancreatic cancer in the PREOPANC-2 trial

Objective: To assess the yield of staging laparoscopy (SL) in a multicenter randomized trial in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma (PDAC) undergoing surgical exploration after neoadjuvant treatment.

Background: Occult metastases may be detected at surgical exploration, leading to a non-therapeutic laparotomy. Starting a surgical exploration with an SL may prevent this, but more prospective data justifying its routine use after neoadjuvant treatment for PDAC is needed.

Methods: This was a prespecified analysis within the multicenter PREOPANC-2 trial, which randomized patients with resectable and borderline resectable PDAC to receive neoadjuvant FOLFIRINOX or gemcitabine-based chemoradiotherapy and adjuvant gemcitabine. The SL was performed in the same surgical session as the intended resection. Primary outcome was the yield of SL to prevent a laparotomy without resection (non-therapeutic laparotomy).

Results: Among 369 randomized patients, 322 (87.2%) ultimately underwent surgical exploration. At surgery, 240 patients (74.5%) underwent SL, including 81 patients (25.2%) scheduled for a robot-assisted resection, and 82 (25.5%) underwent laparotomy without SL. Occult metastases were detected in 39/322 patients (12.1%); in 28/240 with (11.7%) and 11/82 (13.4%) without SL (p=0.675). Of the 28 patients with occult metastases in the SL cohort, 18 (64.3%) did not undergo subsequent laparotomy. Multivariable logistic regression identified tumor size>3 cm (OR: 2.85, 95%CI 1.31 to 6.61, p=0.011) and baseline CA19-9>500 U/ml (OR: 2.92, 95%CI: 1.27 to 6.75, p=0.011) as independent predictors for occult metastatic disease. Without these factors, occult metastatic disease was present in 2.8% of patients (95%CI: 0.9 to 8.0). However, in patients with either tumor size>3 cm or CA19-9 levels>500 U/ml, the prevalence increased to 14.8% (95%CI: 5.9-32.5) and 28.9% (95%CI: 17.0-44.8) with both factors present. The presence of occult metastases was the main reason for abortion of surgery without resection (90.5%). Consequently, the rate of non-therapeutic laparotomy was lower in the SL group (4.5% vs. 17%, p=0.002; number needed-to-treat=8).

Conclusions: The findings of this study highlight the importance of preoperative risk assessment including SL in minimizing non-therapeutic laparotomies.

Publication History

Article published online:
04 September 2025