Delayed gastric emptying after classical Whipple or pylorus-preserving pancreatoduodenectomy: a randomized clinical trial (QUANUPAD)

Purpose Pylorus-preserving pancreatoduodenectomy (PPPD) has been the gold standard for pancreatic head lesion resection for several years. Some studies have noted that it involves more delayed gastric emptying (DGE) than classical Whipple (i.e., pancreatoduodenectomy with antrectomy). Our working hypothesis was that the classical Whipple has a lower incidence of DGE. We aimed to compare the incidence of DGE among pancreatoduodenectomy techniques. Methods This pragmatic, randomized, open-label, single-center clinical trial involved patients who underwent classical Whipple (study group) or PPPD (control group). Gastric emptying was clinically evaluated using scintigraphy. DGE was defined according to the International Study Group of Pancreatic Surgery (ISGPS) criteria. The secondary endpoints were postoperative morbidity, length of hospital stay, anthropometric measurements, and nutritional status. Results A total of 84 patients were randomized (42 per group). DGE incidence was 50% (20/40, 95% confidence interval (95% CI): 35-65%) in the study group and 62% (24/39, 95% CI: 46-75%) in the control group (p = 0.260). No differences were observed between both groups regarding postoperative morbidity or length of hospital stay. Anthropometric measurements at 6 months post-surgery: triceps fold measurements were 12 mm and 16 mm (p = 0.021). At 5 weeks post-surgery, triceps fold measurements were 13 mm and 16 mm (p = 0.020) and upper arm circumferences were 26 cm and 28 cm (p = 0.030). No significant differences were observed in nutritional status. Conclusion DGE incidence and severity did not differ between classical Whipple and PPPD. Some anthropometric measurements may indicate a better recovery with PPPD

Axillary lymph node dissection versus radiotherapy in breast cancer with positive sentinel nodes after neoadjuvant therapy (ADARNAT trial)

IntroductionBreast cancer surgery currently focuses on de-escalating treatment without compromising patient survival. Axillary radiotherapy (ART) now replaces axillary lymph node dissection (ALND) in patients with limited sentinel lymph node (SLN) involvement during the primary surgery, and this has significantly reduced the incidence of lymphedema without worsening the prognosis. However, patients treated with neoadjuvant systemic treatment (NST) cannot benefit from this option despite the low incidence of residual disease in the armpit in most cases. Data regarding the use of radiotherapy instead of ALND in this population are lacking. This study will assess whether ART is non-inferior to ALND in terms of recurrence and overall survival in patients with positive SLN after NST, including whether it reduces surgery-related adverse effects.Methods and analysesThis multicenter, randomized, open-label, phase 3 trial will enroll 1660 patients with breast cancer and positive SLNs following NST in approximately 50 Spanish centers over 3 years. Patients will be stratified by NST regimen and nodal involvement (isolated tumoral cells or micrometastasis versus macrometastasis) and randomly assigned 1:1 to ART without ALND (study arm) or ALND alone (control arm). Level 3 and supraclavicular radiotherapy will be added in both arms. The primary outcome is the 5-year axillary recurrence determined by clinical and radiological examination. The secondary outcomes include lymphedema or arm dysfunction, quality of life based (EORTC QLQ-C30 and QLQ-BR23 questionnaires), disease-free survival, and overall survival.DiscussionThis study aims to provide data to confirm the efficacy and safety of ART over ALND in patients with a positive SLN after NST, together with the impact on morbidity.Ethics and disseminationThe Research Ethics Committee of Bellvitge University Hospital approved this trial (Protocol Record PR148/21, version 3, 1/2/2022) and all patients must provide written informed consent. The involvement of around 50 centers across Spain will facilitate the dissemination of our results.Trial registrationClinicalTrials.gov, identifier number NCT04889924

Additional tracer injection to improve the technical success rate of lymphoscintigraphy for sentinel node biopsy in breast cancer

BACKGROUND: Sentinel node (SN) biopsy has become the standard of care in the treatment of breast cancer. The aim of this study is to determine the value of additional tracer injection to increase the technical success rate of the SN procedure and to identify factors that influence the ability to visualize hotspots. METHODS: From February 1997 to August 2007, 1,208 clinically node-negative breast cancer patients underwent lymphatic mapping for SN biopsy. The technique involved the injection of 370 MBq (10 mCi) Tc-99 m-nanocolloid peritumorally. In case of insufficient or absent visualization of hotspots 37 MBq (1 mCi) of additional tracer was given intracutaneously above the tumor. RESULTS: In 93 patients (7.7%) visualization of hotspots on initial lymphoscintigraphy was insufficient (41 patients) or absent (52 patients). The first 14 patients did not receive additional tracer injection. In five patients, additional tracer did not result in successful lymphoscintigraphy, which is correlated with massive nodal tumor infiltration. In 33 patients with negative initial lymphoscintigraphy, additional tracer injection resulted in secondary SN visualization. In 41 patients with faint hotspots on initial lymphoscintigraphy, additional tracer injection, by increasing nodal uptake, simplified accurate SN biopsy. Decreased radiotracer uptake in this group was associated with older age and high body mass index (BMI). CONCLUSIONS: Additional tracer injection following initial scan failure increases the success rate of lymphoscintigraphy during lymphatic mapping in breast cancer, without compromising accuracy. If additional tracer injection does not result in secondary SN visualization, gross nodal tumor involvement is often present and axillary lymph node dissection (ALND) is mandatory