Paravertebral versus EPidural Analgesia in Minimally Invasive Esophageal ResectioN (PEPMEN): A Randomized Controlled Multicenter Trial.

OBJECTIVE: To compare quality of recovery in patients receiving epidural or paravertebral analgesia for minimally invasive esophagectomy (MIE). SUMMARY BACKGROUND DATA: Paravertebral analgesia may be a promising alternative to epidural analgesia, avoiding potential side effects and improving postoperative recovery. METHODS: This randomized controlled superiority trial was conducted across four Dutch centers with esophageal cancer patients scheduled for transthoracic MIE with intrathoracic anastomosis, randomizing patients to receive either epidural or paravertebral analgesia. The primary outcome was Quality of Recovery (QoR-40) on the third postoperative day (POD). Secondary outcomes included quality of life, postoperative pain, opioid consumption, inotropic/vasopressor medication use, hospital stay, complications, readmission, and mortality. RESULTS: From December 2019 to February 2023, 192 patients were included: 94 received epidural and 98 paravertebral analgesia. QoR-40 score on POD3 was not different between groups (mean difference 3.7, 95%CI -2.3 to 9.7; P=0.268). Epidural patients had significant higher QoR-40 scores on POD1 and 2 (mean difference 7.7, 95%CI 2.3-13.1; P=0.018 and mean difference 7.3, 95%CI 1.9-12.7; P=0.020) and lower pain scores (median 1 versus 2; P=<0.001 and median 1 versus 2; P=0.033). More epidural patients required vasopressor medication on POD1 (38.3% versus 13.3%; P<0.001). Urinary catheters were removed earlier in the paravertebral group (median POD3 versus 4; P=<0.001). No significant differences were found in postoperative complications or hospital/Intensive Care Unit stay. CONCLUSIONS: This randomized controlled trial did not demonstrate superiority of paravertebral over epidural analgesia regarding quality of recovery on POD3 after MIE. Both techniques are effective and can be offered in clinical practice.

Current perioperative care in patients undergoing a beyond total mesorectal excision procedure for rectal cancer: What are the differences with the colorectal enhanced recovery after surgery protocol?

AIM: Patients requiring a beyond total mesorectal excision (bTME) procedure for locally advanced rectal cancer (LARC) and locally recurrent rectal cancer (LRRC) will probably benefit from enhanced recovery after surgery (ERAS) protocols. However, implementation of ERAS protocols in such groups of patients is considered challenging. The aims of this study were to evaluate ERAS-related outcomes of patients with LARC or LRRC undergoing bTME and to investigate the possibility of designing a tailored ERAS protocol. METHOD: This study was divided into four phases. Phase one consisted of a literature study to compare functional recovery and postoperative outcomes in patients undergoing bTME. In phase two, outcomes on ERAS care elements in bTME were retrospectively evaluated. In phase three, differences in ERAS-related outcomes and compliance of the colorectal ERAS protocol in patients who had undergone bTME were studied. In phase four, multidisciplinary team meetings were held to develop an ERAS protocol for bTME patients. RESULTS: Seven studies reported on ERAS-related outcomes in patients undergoing bTME. Median length of hospital stay was 9-19 days, median stay in the intensive care unit was 2-4 days and 30-day postoperative major complication rates were 22.6%-61.3%. Seventy-five bTME patients were included for retrospective analysis. In these patients, length of stay was 9.0 days and major postoperative complications were observed in 40.0%. The overall ERAS compliance was 44.4%. Compared with the colorectal ERAS protocol, the largest differences in management were observed in the use of epidural anaesthesia, the postoperative use of urethral catheters, oral intake and mobilization. CONCLUSION: Patients undergoing bTME for LARC or LRRC are substantially different from patients treated with the colorectal ERAS protocol, regarding ERAS-related outcomes. A tailored, multimodal ERAS protocol with specific modifications was developed by an expert multidisciplinary team for patients undergoing bTME for LARC or LRRC.

Histopathological response to chemotherapy and survival of mucinous type gastric cancer.

BACKGROUND: Data on the clinicopathological characteristics of mucinous gastric cancer (muc-GC) are limited. This study compares the clinical outcome and response to chemotherapy between patients with resectable muc-GC, intestinal (int-GC) and diffuse (dif-GC) gastric cancer. METHODS: Patients from the D1/D2 study or the CRITICS trial were included in exploratory surgery-alone (SAtest) or chemotherapy test (CTtest) cohorts. Real-world data from the Netherlands Cancer Registry on patients treated between with surgery-alone (SAvalidation), and receiving preoperative chemotherapy with or without postoperative treatment (CTvalidation) were used for validation. Histopathological subtypes were extracted from pathology reports filed in the Dutch Pathology Registry and correlated with tumor regression grade (TRG) and relative survival (RS). RESULTS: In SAtest (n = 549) and SAvalidation (n = 8062) cohorts, muc-GC patients had a five-year RS of 39% and 31%, similar to or slightly better than dif-GC (43% and 29%, p = .52 and p = .011), but worse than int-GC (55% and 42%, p = .11 and p < .001). In CTtest (n = 651) and CTvalidation (n = 2889) cohorts, muc-GC showed favorable TRG (38% and 44% (near-)complete response) compared to int-GC (26% and 35%) and dif-GC (10% and 28%, p < .001 and p = .005). The 5-year RS in CTtest and CTvalidation cohorts for muc-GC (53% and 48%) and int-GC (58% and 59%) was significantly better compared to dif-GC (35% and 38%, p = .004 and p < .001). CONCLUSION: Recognizing and incorporating muc-GC into treatment decision-making of resectable GC can lead to more personalized and effective approaches, given its favorable response to preoperative chemotherapy in relation to int-GC and dif-GC and its favorable prognostic outcomes in relation to dif-GC.

Electrical vagus nerve stimulation is a promising approach to reducing pulmonary complications after an esophagectomy: an experimental rodent model.

After esophagectomy, an imbalanced inflammatory response increases the risk of postoperative morbidity. The vagus nerve modulates local and systemic inflammatory responses, but its pulmonary branches are transected during esophagectomy as part of the oncological resection, which may account for the high incidence of postoperative (pulmonary) complications. This study investigated the effect of electrical vagus nerve stimulation (VNS) on lipopolysaccharide (LPS)-induced lung injury in rats. Rats (n = 60) were randomly assigned to a non-vagotomy or cervical vagotomy group, with VNS or without (NOSTIM). There were four non-vagotomy groups: NOSTIM and bilateral VNS with 100, 50, or 10 µA. The four vagotomy groups were NOSTIM and VNS with fixed amplitude (50 µA) bilaterally before (VNS-50-before) or after bilateral vagotomy (VNS-50-after), or unilaterally (left) before ipsilateral vagotomy (VNS-50-unilaterally). LPS was administered intratracheally after surgery. Pulmonary function, pro-inflammatory cytokines in serum, broncho-alveolar lavage fluid (BALF), and histopathological lung injury (LIS) were assessed 180 min post-procedure. In non-vagotomized rats, neutrophil influx in BALF following intra-tracheal LPS (mean 30 [± 23]; P = 0.075) and LIS (mean 0.342 [± 0.067]; P = 0.142) were similar after VNS-100, compared with NOSTIM. VNS-50 reduced neutrophil influx (23 [± 19]; P = 0.024) and LIS (0.316 [± 0.093]; P = 0.043). VNS-10 reduced neutrophil influx (15 [± 6]; P = 0.009), while LIS (0.331 [± 0.053]; P = 0.088) was similar. In vagotomized rats, neutrophil influx (52 [± 37]; P = 0.818) and LIS (0.407 [SD ± 0.037]; P = 0.895) in VNS-50-before were similar compared with NOSTIM, as well as in VNS-50-after (neutrophils 30 [± 26]; P = 0.090 and LIS 0.344 [± 0.053]; P = 0.073). In contrast, VNS-50-unilaterally reduced neutrophil influx (26 [± 10]; P = 0.050) and LIS (0.296 [± 0.065]; P = 0.005). Systemic levels of cytokines TNF-α and IL-6 were undetectable in all groups. Pulmonary function was not statistically significantly affected. In conclusion, VNS limited influx of neutrophils in lungs in non-vagotomized rats and may attenuate LIS. Unilateral VNS attenuated lung injury even after ipsilateral vagotomy. This effect was absent for bilateral VNS before and after bilateral vagotomy. It is suggested that the effect of VNS is dependent on (partially) intact vagus nerves and that the level of the vagotomy during esophagectomy may influence postoperative pulmonary outcomes.

Interval Metastases After Neoadjuvant Chemoradiotherapy for Patients with Locally Advanced Esophageal Cancer: A Multicenter Observational Cohort Study.

BACKGROUND: Despite trimodality treatment, 10% to 20% of patients with esophageal cancer experience interval metastases after surgery. Restaging may identify patients who should not proceed to surgery, as well as a subgroup with limited metastases for whom long-term disease-control can be obtained. This study aimed to determine the proportion of patients with interval metastases after neoadjuvant chemoradiotherapy (nCRT) and to evaluate treatment and survival. METHODS: Patients who had cT2-4aN0-3M0 esophageal cancer treated with nCRT were identified from a trial database. Metastases detected up to 14 weeks after nCRT on 18F-FDG-PET/CT or during surgery were categorized as oligometastases (≤3 lesions located in one single organ or one extra-regional lymph node station) or as non-oligometastases. The primary outcome was the proportion of patients with metastases after nCRT. The secondary outcomes were overall survival (OS) and the site and treatment of metastases. RESULTS: Between 2013 and 2021, 973 patients received nCRT, and 10.3% had interval metastases. Of 100 patients, 30 (30%) had oligometastases, located mostly in non-regional lymph nodes (33.3%) or bones (26.7%). The median OS of this group was 13.8 months (95% confidence interval [CI] 9.2-27.1 months). Of 30 patients, 12 (40%) with oligometastases underwent potentially curative treatment, with a median OS of 22.8 months (95% CI 10.4-NA). The patients with non-oligometastases underwent mostly systemic therapy or BSC and had a median OS of 9 months (95% CI 7.4-10.9 months). CONCLUSIONS: Interval metastases were detected in about 10% of patients after nCRT, underscoring the importance of re-staging with 18F-FDG-PET/CT for those who proceed to surgery. A favorable survival might be accomplished for a subgroup of patients with oligometastases.

Oncologic outcomes of de-escalating axillary treatment in clinically node-positive breast cancer patients treated with neoadjuvant systemic therapy - A two center cohort study.

BACKGROUND: The aim of the present study was to report the 5-year axillary recurrence-free interval (aRFI) in clinically node-positive breast cancer patients treated according to a de-escalating axillary treatment protocol after neoadjuvant systemic therapy (NST). METHODS: All patients diagnosed in two hospitals between October 2014 and March 2021 were identified retrospectively. Data on diagnostic workup, treatment and follow-up was collected. Adjuvant axillary treatment was considered based on the initial staging using 18F-FDG PET/CT and the results of axillary lymph node marking with a radioactive-iodine seed protocol or a targeted axillary dissection procedure. Follow-up was updated until 27th April 2024. Kaplan-Meier curves were calculated to report the 5-year aRFI with corresponding 95 % confident intervals (95%-CI). RESULTS: A total of 199 patients were included. Axillary pathological complete response was reported in 66 (33.2 %). Based on the treatment protocol and initial clinical staging, no adjuvant axillary treatment was indicated in 30 patients (15 %), while 139 (70 %) received axillary radiotherapy without performance of an axillary lymph node dissection (ALND). The remaining 30 patients (15 %) underwent an ALND with additional locoregional radiotherapy. A median follow-up of 62 months (30-106) showed that 4 (2 %) patients experienced an axillary recurrence after 7, 8, 36 and 36 months, respectively. In all 4 patients, synchronous distant metastases were diagnosed. The estimated 5-year aRFI was 97.8 % (95%-CI 95.6-99.9 %) CONCLUSION: Although longer follow-up should be awaited before final conclusions can be drawn regarding the oncological safety of this approach, the implementation of a de-escalating axillary treatment protocol appears to be safe since the estimated 5-year aRFI is 97.8 %.

Expectations and needs of patients with esophageal cancer during curative treatment regarding self-management, self-management support and eHealth: a qualitative study.

PURPOSE: Self-management is an essential component of the curative treatment trajectory of esophageal cancer patients. The aims of this study were to explore expectations and needs of esophageal cancer patients during curative treatment regarding self-management, relevant aspects of self-management in which they need additional support, and to explore their willingness to use eHealth. METHODS: Semi-structured interviews were conducted with esophageal cancer patients, who had been treated with neoadjuvant chemo(radio)therapy followed by surgery, maximally 1 year after surgery. Based on the general model of self-management, the following themes were discussed: experience-based knowledge, contribution to care, living with the condition, and organization of care and support. A stepwise systematic text condensation guided the data analysis. RESULTS: All four domains of the general model of self-management were identified. All participants described a remarkable difference between the pre-operative pathway, when it felt like they were taken by the hand, and the postoperative pathway, when it felt like they were thrown into the deep end. They adjusted to their new life situation by learning new experiences, while dealing with their diminished confidence in their bodies. Patients expressed the need for support from different sources, and were open to the idea of using eHealth in addition to usual care. (digital) Self-management support should be easily accessible, person-centered, confidential, and include personal contact. CONCLUSION: Differences were found among esophageal cancer patients regarding self-management, self-management support and eHealth for self-management purposes, indicating there is no one approach that will meet the needs of all patients at all times.

European clinical practice guidelines for the definition, diagnosis, and treatment of oligometastatic esophagogastric cancer (OMEC-4)

The OligoMetastatic Esophagogastric Cancer (OMEC) project aims to provide clinical practice guidelines for the definition, diagnosis, and treatment of esophagogastric oligometastatic disease (OMD). Guidelines were developed according to AGREE II and GRADE principles. Guidelines were based on a systematic review (OMEC-1), clinical case discussions (OMEC-2), and a Delphi consensus study (OMEC-3) by 49 European expert centers for esophagogastric cancer. OMEC identified patients for whom the term OMD is considered or could be considered. Disease-free interval (DFI) was defined as the time between primary tumor treatment and detection of OMD. Moderate to high quality of evidence was found (i.e. 1 randomized and 4 non-randomized phase II trials) resulting in moderate recommendations. OMD is considered in esophagogastric cancer patients with 1 organ with ≤ 3 metastases or 1 involved extra-regional lymph node station. In addition, OMD continues to be considered in patients with OMD without progression in number of metastases after systemic therapy. 18F-FDG PET/CT imaging is recommended for baseline staging and for restaging after systemic therapy when local treatment is considered. For patients with synchronous OMD or metachronous OMD and a DFI ≤ 2 years, recommended treatment consists of systemic therapy followed by restaging to assess suitability for local treatment. For patients with metachronous OMD and DFI > 2 years, upfront local treatment is additionally recommended. These multidisciplinary European clinical practice guidelines for the uniform definition, diagnosis and treatment of esophagogastric OMD can be used to standardize inclusion criteria in future clinical trials and to reduce variation in treatment.

Breast conserving surgery with intraoperative electron beam radiation therapy for low-risk breast cancer: Five-year follow-up of 306 patients.

Recent studies have reported a higher than expected risk of ipsilateral breast tumor recurrence (IBTR) after breast conserving surgery (BCS) and a single dose of electron beam intra-operative radiotherapy (IORT). This finding was the rationale to perform a retrospective single center cohort study evaluating the oncologic results of consecutive patients treated with BCS and IORT. Women were eligible if they had clinical low-risk (N0, ≤2 cm unifocal, Bloom and Richardson grade 1-2), estrogen receptor-positive and human-epidermal-growth-factor-receptor-2-negative breast cancer. Prior to BCS, pN0 status was determined by sentinel lymph node biopsy. Data on oncologic follow-up were analyzed. Between 2012 and 2019, 306 consecutive patients were treated and analyzed, with a median age of 67 (50-86) years at diagnosis. Median follow-up was 60 (8-120) months. Five-year cumulative risk of IBTR was 13.4% (95% confidence interval [CI] 9.4-17.4). True in field recurrence was present in 3.9% of the patients. In 4.6% of the patients, the IBRT was classified as a local recurrence due to seeding of tumor cells in the cutis or subcutis most likely related to percutaneous biopsy. In 2.9% of the patients, the IBRT was a new outfield primary tumor. Three patients had a regional lymph node recurrence and two had distant metastases as first event. One breast cancer-related death was observed. Estimated 5-year overall survival was 89.8% (95% CI 86.0-93.6). In conclusion, although some of IBTR cases could have been prevented by adaptations in biopsy techniques and patient selection, BCS followed by IORT was associated with a substantial risk of IBTR.

Effects of a perioperative educational pathway on ostomy self-care, level of independence and need for visiting nurse services: a comparative observational cohort study.

AIM: Most new ostomy patients are not able to manage ostomy self-care when they are discharged and rely on visiting nurse services for ostomy care. The aim of this study was to determine if a perioperative ostomy educational pathway increases the level of independence and decreases the need for visiting nurse services in new ostomy patients. METHOD: A prospective longitudinal study was conducted between July 2018 and February 2020. Patients who received a colostomy or ileostomy and were treated on the surgery ward were included. Patients who followed a perioperative ostomy educational pathway were compared to a historical control group. The primary outcome measure was the level of independence in ostomy care and the need for visiting nurse services. RESULTS: After discharge, 67.6% of patients in the intervention group (n = 244) were able to independently perform ostomy care and were therefore not relying on visiting nurse services, compared to 15.2% of the patients in the control group (n = 33). The need for visiting nurse services was higher in patients aged ≥70 years (OR 3.20, P < 0.001), those who did not attend the preoperative practice session (OR 3.02, P = 0.002), those with a history of transient ischaemic attack (OR 10.22, P = 0.045) and those with mild cognitive impairment (OR 28.98, P = 0.002). CONCLUSION: A perioperative ostomy educational pathway effectively increased the level of independence and decreased the need for visiting nurse services in new ostomy patients.

Nationwide Association of Surgical Performance of Minimally Invasive Esophagectomy With Patient Outcomes.

Importance: Suboptimal surgical performance is hypothesized to be associated with less favorable patient outcomes in minimally invasive esophagectomy (MIE). Establishing this association may lead to programs that promote better surgical performance of MIE and improve patient outcomes. Objective: To investigate associations between surgical performance and postoperative outcomes after MIE. Design, Setting, and Participants: In this nationwide cohort study of 15 Dutch hospitals that perform more than 20 MIEs per year, 7 masked expert MIE surgeons assessed surgical performance using videos and a previously developed and validated competency assessment tool (CAT). Each hospital submitted 2 representative videos of MIEs performed between November 4, 2021, and September 13, 2022. Patients registered in the Dutch Upper Gastrointestinal Cancer Audit between January 1, 2020, and December 31, 2021, were included to examine patient outcomes. Exposure: Hospitals were divided into quartiles based on their MIE-CAT performance score. Outcomes were compared between highest (top 25%) and lowest (bottom 25%) performing quartiles. Transthoracic MIE with gastric tube reconstruction. Main Outcome and Measure: The primary outcome was severe postoperative complications (Clavien-Dindo ≥3) within 30 days after surgery. Multilevel logistic regression, with clustering of patients within hospitals, was used to analyze associations between performance and outcomes. Results: In total, 30 videos and 970 patients (mean [SD] age, 66.6 [9.1] years; 719 men [74.1%]) were included. The mean (SD) MIE-CAT score was 113.6 (5.5) in the highest performance quartile vs 94.1 (5.9) in the lowest. Severe postoperative complications occurred in 18.7% (41 of 219) of patients in the highest performance quartile vs 39.2% (40 of 102) in the lowest (risk ratio [RR], 0.50; 95% CI, 0.24-0.99). The highest vs the lowest performance quartile showed lower rates of conversions (1.8% vs 8.9%; RR, 0.21; 95% CI, 0.21-0.21), intraoperative complications (2.7% vs 7.8%; RR, 0.21; 95% CI, 0.04-0.94), and overall postoperative complications (46.1% vs 65.7%; RR, 0.54; 95% CI, 0.24-0.96). The R0 resection rate (96.8% vs 94.2%; RR, 1.03; 95% CI, 0.97-1.05) and lymph node yield (mean [SD], 38.9 [14.7] vs 26.2 [9.0]; RR, 3.20; 95% CI, 0.27-3.21) increased with oncologic-specific performance (eg, hiatus dissection, lymph node dissection). In addition, a high anastomotic phase score was associated with a lower anastomotic leakage rate (4.6% vs 17.7%; RR, 0.14; 95% CI, 0.06-0.31). Conclusions and Relevance: These findings suggest that better surgical performance is associated with fewer perioperative complications for patients with esophageal cancer on a national level. If surgical performance of MIE can be improved with MIE-CAT implementation, substantially better patient outcomes may be achievable.

Perioperative Chemotherapy for Gastro-Esophageal or Gastric Cancer: Anthracyclin Triplets versus FLOT.

Background: The FLOT4-AIO trial (2019) showed improved survival with perioperative fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) compared to anthracyclin triplets in gastric cancer treatment. It is unclear whether these results extend to real-world scenarios in the Netherlands. This study aimed to compare outcomes of perioperative FLOT to anthracyclin triplets in a real-world Dutch gastric cancer population. Methods: Patients diagnosed with resectable (cT2-4a/cTxN0-3/NxM0) gastric or gastro-esophageal junction carcinoma between 2015-2021 who received neoadjuvant FLOT or anthracyclin triplets were selected from the Netherlands Cancer Registry. The primary outcome was overall survival (OS), analyzed through multivariable Cox regression. Secondary outcomes included pathological complete response (pCR), neoadjuvant chemotherapy cycle completion, surgical resection rates, and adjuvant therapy. Results: Adjusted OS showed no significant survival benefit (HR = 0.88, 95% CI 0.77-1.01, p = 0.07), even though the median OS was numerically improved by 8 months with FLOT compared to anthracyclin triplets (48.1 vs. 39.9 months, p = 0.16). FLOT patients were more likely to undergo diagnostic staging laparoscopies (74.2% vs. 44.1%, p < 0.001), had higher rates of completing neoadjuvant chemotherapy (OR = 1.35, 95% CI 1.09-1.68, p = 0.007), receiving adjuvant therapy (OR = 1.34, 95% CI 1.08-1.66, p = 0.08), and achieving pCR (OR = 1.52, 95% CI 1.05-2.20, p = 0.03). No significant differences were observed in (radical) resection rates. Conclusion(s): Real-world data showed no significant OS improvement for FLOT-treated patients compared to anthracyclin triplets, despite more staging laparoscopies. However, FLOT patients demonstrated higher rates of neoadjuvant therapy completion, proceeding to adjuvant therapy, and increased pCR rates. Therefore, we recommend the continued use of neoadjuvant FLOT therapy in the current clinical setting.

European clinical practice guidelines for the definition, diagnosis, and treatment of oligometastatic esophagogastric cancer (OMEC-4).

INTRODUCTION: The OligoMetastatic Esophagogastric Cancer (OMEC) project aims to provide clinical practice guidelines for the definition, diagnosis, and treatment of esophagogastric oligometastatic disease (OMD). METHODS: Guidelines were developed according to AGREE II and GRADE principles. Guidelines were based on a systematic review (OMEC-1), clinical case discussions (OMEC-2), and a Delphi consensus study (OMEC-3) by 49 European expert centers for esophagogastric cancer. OMEC identified patients for whom the term OMD is considered or could be considered. Disease-free interval (DFI) was defined as the time between primary tumor treatment and detection of OMD. RESULTS: Moderate to high quality of evidence was found (i.e. 1 randomized and 4 non-randomized phase II trials) resulting in moderate recommendations. OMD is considered in esophagogastric cancer patients with 1 organ with ≤ 3 metastases or 1 involved extra-regional lymph node station. In addition, OMD continues to be considered in patients with OMD without progression in number of metastases after systemic therapy. 18F-FDG PET/CT imaging is recommended for baseline staging and for restaging after systemic therapy when local treatment is considered. For patients with synchronous OMD or metachronous OMD and a DFI ≤ 2 years, recommended treatment consists of systemic therapy followed by restaging to assess suitability for local treatment. For patients with metachronous OMD and DFI > 2 years, upfront local treatment is additionally recommended. DISCUSSION: These multidisciplinary European clinical practice guidelines for the uniform definition, diagnosis and treatment of esophagogastric OMD can be used to standardize inclusion criteria in future clinical trials and to reduce variation in treatment.

Factors associated with one-year mortality after curative surgery for primary clinical T4 and locally recurrent rectal cancer in elderly patients.

INTRODUCTION: Despite advancements in colorectal cancer care, one-year post-operative mortality rates remain high for elderly patients who have undergone curative surgery for primary clinical T4 rectal cancer (cT4RC) or locally recurrent rectal cancer (LRRC). This study aimed to identify factors associated with one-year mortality and to evaluate the causes of death. MATERIALS & METHODS: This retrospective cohort study included patients aged ≥70 years who underwent surgery with curative intent for cT4RC or LRRC between January 2013 and December 2020. Clinical and follow-up data were collected and analyzed to determine survival rates and investigate factors associated with mortality within one year after surgery. RESULTS: A total of 183 patients (94 cT4RC, 89 LRRC) were included. One-year mortality rates were 16.0% for cT4RC and 28.1% for LRRC (P = 0.064). In cT4RC patients, factors associated with one-year mortality were preoperative anemia (OR 3.83, P = 0.032), total pelvic exenteration (TPE) (OR 7.18, P = 0.018), multivisceral resections (OR 5.73, P = 0.028), pulmonary complications (OR 13.31, P < 0.001) and Clavien-Dindo grade ≥ III complications (OR 5.19, P = 0.025). In LRRC patients, factors associated with one-year mortality were TPE (OR 27.00, P = 0.008), the need for supported care after discharge (OR 3.93, P = 0.041) and Clavien-Dindo grade ≥ III complications (OR 3.95, P = 0.006). The main causes of death in cT4RC and LRRC patients were failure to recover (cT4RC 26.6%, LRRC 28.0%) and disease recurrence (cT4RC 26.6%, LRRC 60.0%). CONCLUSION: In order to tailor treatment in elderly with cT4RC and LRRC, factors associated with increased one-year mortality (e.g. pre-operative anemia, TPE) should be incorporated in the decision-making process. CLINICAL TRIAL REGISTRATION: Not applicable.

Impact of 18FFDG-PET/CT and Laparoscopy in Staging of Locally Advanced Gastric Cancer: A Cost Analysis in the Prospective Multicenter PLASTIC-Study.

BACKGROUND: Unnecessary D2-gastrectomy and associated costs can be prevented after detecting non-curable gastric cancer, but impact of staging on treatment costs is unclear. This study determined the cost impact of 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18FFDG-PET/CT) and staging laparoscopy (SL) in gastric cancer staging. MATERIALS AND METHODS: In this cost analysis, four staging strategies were modeled in a decision tree: (1) 18FFDG-PET/CT first, then SL, (2) SL only, (3) 18FFDG-PET/CT only, and (4) neither SL nor 18FFDG-PET/CT. Costs were assessed on the basis of the prospective PLASTIC-study, which evaluated adding 18FFDG-PET/CT and SL to staging advanced gastric cancer (cT3-4 and/or cN+) in 18 Dutch hospitals. The Dutch Healthcare Authority provided 18FFDG-PET/CT unit costs. SL unit costs were calculated bottom-up. Gastrectomy-associated costs were collected with hospital claim data until 30 days postoperatively. Uncertainty was assessed in a probabilistic sensitivity analysis (1000 iterations). RESULTS: 18FFDG-PET/CT costs were €1104 including biopsy/cytology. Bottom-up calculations totaled €1537 per SL. D2-gastrectomy costs were €19,308. Total costs per patient were €18,137 for strategy 1, €17,079 for strategy 2, and €19,805 for strategy 3. If all patients undergo gastrectomy, total costs were €18,959 per patient (strategy 4). Performing SL only reduced costs by €1880 per patient. Adding 18FFDG-PET/CT to SL increased costs by €1058 per patient; IQR €870-1253 in the sensitivity analysis. CONCLUSIONS: For advanced gastric cancer, performing SL resulted in substantial cost savings by reducing unnecessary gastrectomies. In contrast, routine 18FFDG-PET/CT increased costs without substantially reducing unnecessary gastrectomies, and is not recommended due to limited impact with major costs. TRIAL REGISTRATION: NCT03208621. This trial was registered prospectively on 30-06-2017.

The impact of hospital experience in bariatric surgery on short-term outcomes after minimally invasive esophagectomy: a nationwide analysis.

BACKGROUND: Minimally invasive esophagectomy (MIE) is a technically challenging procedure with a substantial learning curve. Composite volume of upper gastrointestinal (upper GI) procedures for cancer has been previously linked to postoperative outcomes. This study aimed to investigate an association between hospital experience in bariatric surgery and short-term outcomes in MIE. METHOD: Data on esophagectomy patients between 2016 and 2020 were collected from the Dutch Upper Gastrointestinal Cancer Audit, a mandatory nationwide registry. Hospitals were categorized as bariatric or non-bariatric. Multivariable logistic regression investigated short-term postoperative outcomes, adjusting for case mix. RESULTS: Of 3371 patients undergoing esophagectomy in sixteen hospitals, 2450 (72.7%) underwent MIE. Bariatric hospitals (N = 6) accounted for 1057 (43.1%) MIE. Annual volume of bariatric procedures was median 523 and esophagectomies 42. In non-bariatric hospitals, volume of esophagectomies was median 52 (P = 0.145). Overall postoperative complication rate was lower in bariatric hospitals (59.2% vs. 65.9%, P < 0.001). Bariatric hospitals were associated with a reduced risk of overall complications (aOR 0.76 [95% CI 0.62-0.92]), length of hospital (aOR 0.79 [95% CI 0.65-0.95]), and ICU stay (aOR 0.81 [95% CI 0.67-0.98]) after MIE. Surgical radicality (R0) did not differ. Lymph node yield (≥ 15) was lower in bariatric hospitals (90.0% vs. 94.7%, P < 0.001). Over the years, several short-term outcomes improved in bariatric hospitals compared to non-bariatric hospitals. CONCLUSION: In this nationwide analysis, there was an association between bariatric hospitals and improved short-term outcomes after MIE. Characteristics of bariatric hospitals that could explain this phenomenon and whether this translates to other upper GI procedures may be warranted to identify.

A Video-Based Procedure-Specific Competency Assessment Tool for Minimally Invasive Esophagectomy.

Importance: Minimally invasive esophagectomy (MIE) is a complex procedure with substantial learning curves. In other complex minimally invasive procedures, suboptimal surgical performance has convincingly been associated with less favorable patient outcomes as assessed by peer review of the surgical procedure. Objective: To develop and validate a procedure-specific competency assessment tool (CAT) for MIE. Design, Setting, and Participants: In this international quality improvement study, a procedure-specific MIE-CAT was developed and validated. The MIE-CAT contains 8 procedural phases, and 4 quality components per phase are scored with a Likert scale ranging from 1 to 4. For evaluation of the MIE-CAT, intraoperative MIE videos performed by a single surgical team in the Esophageal Center East Netherlands were peer reviewed by 18 independent international MIE experts (with more than 120 MIEs performed). Each video was assessed by 2 or 3 blinded experts to evaluate feasibility, content validity, reliability, and construct validity. MIE-CAT version 2 was composed with refined content aimed at improving interrater reliability. A total of 32 full-length MIE videos from patients who underwent MIE between 2011 and 2020 were analyzed. Data were analyzed from January 2021 to January 2023. Exposure: Performance assessment of transthoracic MIE with an intrathoracic anastomosis. Main Outcomes and Measures: Feasibility, content validity, interrater and intrarater reliability, and construct validity, including correlations with both experience of the surgical team and clinical parameters, of the developed MIE-CAT. Results: Experts found the MIE-CAT easy to understand and easy to use to grade surgical performance. The MIE-CAT demonstrated good intrarater reliability (range of intraclass correlation coefficients [ICCs], 0.807 [95% CI, 0.656 to 0.892] for quality component score to 0.898 [95% CI, 0.846 to 0.932] for phase score). Interrater reliability was moderate (range of ICCs, 0.536 [95% CI, -0.220 to 0.994] for total MIE-CAT score to 0.705 [95% CI, 0.473 to 0.846] for quality component score), and most discrepancies originated in the lymphadenectomy phases. Hypothesis testing for construct validity showed more than 75% of hypotheses correct: MIE-CAT performance scores correlated with experience of the surgical team (r = 0.288 to 0.622), blood loss (r = -0.034 to -0.545), operative time (r = -0.309 to -0.611), intraoperative complications (r = -0.052 to -0.319), and severe postoperative complications (r = -0.207 to -0.395). MIE-CAT version 2 increased usability. Interrater reliability improved but remained moderate (range of ICCs, 0.666 to 0.743), and most discrepancies between raters remained in the lymphadenectomy phases. Conclusions and Relevance: The MIE-CAT was developed and its feasibility, content validity, reliability, and construct validity were demonstrated. By providing insight into surgical performance of MIE, the MIE-CAT might be used for clinical, training, and research purposes.

Long-Term Survival Associated with Direct Oral Feeding Following Minimally Invasive Esophagectomy: Results from a Randomized Controlled Trial (NUTRIENT II).

Advancements in perioperative care have improved postoperative morbidity and recovery after esophagectomy. The direct start of oral intake can also enhance short-term outcomes following minimally invasive Ivor Lewis esophagectomy (MIE-IL). Subsequently, short-term outcomes may affect long-term survival. This planned sub-study of the NUTRIENT II trial, a multicenter randomized controlled trial, investigated the long-term survival of direct versus delayed oral feeding following MIE-IL. The outcomes included 3- and 5-year overall survival (OS) and disease-free survival (DFS), and the influence of complications and caloric intake on OS. After excluding cases of 90-day mortality, 145 participants were analyzed. Of these, 63 patients (43.4%) received direct oral feeding. At 3 years, OS was significantly better in the direct oral feeding group (p = 0.027), but not at 5 years (p = 0.115). Moreover, 5-year DFS was significantly better in the direct oral feeding group (p = 0.047) and a trend towards improved DFS was shown at 3 years (p = 0.079). Postoperative complications and caloric intake on day 5 did not impact OS. The results of this study show a tendency of improved 3-year OS and 5-year DFS, suggesting a potential long-term survival benefit in patients receiving direct oral feeding after esophagectomy. However, the findings should be further explored in larger future trials.

An evaluation of postoperative outcomes and treatment changes after frailty screening and geriatric assessment and management in a cohort of older patients with colorectal cancer.

INTRODUCTION: Adequate patient selection is crucial within the treatment of older patients with colorectal cancer (CRC). While previous studies report increased morbidity and mortality in older patients screened positive for frailty, improvements in the perioperative care and postoperative outcomes have raised the question of whether older patients screened positive for frailty still face worse outcomes. This study aimed to investigate the postoperative outcomes of older patients with CRC screened positive for frailty, and to evaluate changes in treatment after frailty screening and geriatric assessment. MATERIALS AND METHODS: Patients ≥70 years with primary CRC who underwent frailty screening between 1 January 2019 and 31 October 2021 were included. Frailty screening was performed by the Geriatric-8 (G8) screening tool. If the G8 indicated frailty (G8 ≤ 14), patients were referred for a comprehensive geriatric assessment (CGA). Postoperative outcomes and changes in treatment based on frailty screening and CGA were evaluated. RESULTS: A total of 170 patients were included, of whom 74 (43.5%) screened positive for frailty (G8 ≤ 14). Based on the CGA, the initially proposed treatment plan was altered to a less intensive regimen in five (8.9%) patients, and to a more intensive regimen in one (1.8%) patient. Surgery was performed in 87.8% of patients with G8 ≤ 14 and 96.9% of patients with G8 > 14 (p = 0.03). Overall postoperative complications were similar between patients with G8 ≤ 14 and G8 > 14 (46.2% vs. 47.3%, p = 0.89). Postoperative delirium was observed in 7.7% of patients with G8 ≤ 14 and 1.1% of patients with G8 > 14 (p = 0.08). No differences in 30-day mortality (1.1% vs. 1.5%, p > 0.99) or one-year and two-year survival rates were observed (log rank, p = 0.26). DISCUSSION: Although patients screened positive for frailty underwent CRC surgery less often, those considered eligible for surgery can safely undergo CRC resection within current clinical care pathways, without increased morbidity and mortality. Efforts to optimise perioperative care and minimise the risk of postoperative complications, in particular delirium, seem warranted. A multidisciplinary onco-geriatric pathway may support tailored decision-making in patients at risk of frailty.