Robotic-assisted laparoscopic resection of a pelvic solitary fibrous tumour causing distal ureteric compression.

This case report describes a male in his late 40s with a 4 cm pelvic mass compressing the left distal ureter, resulting in left hydroureteronephrosis. Biopsy of the mass was suggestive of a solitary fibrous tumour. The patient underwent a robotic-assisted laparoscopic excision of the left pelvic mass. Intraoperatively, the mass was found to be densely adhered to the ureter, necessitating a left distal ureterectomy and ureteric reimplantation. Subsequent histopathological analysis revealed the mass was a solitary fibrous tumour with no evidence of malignancy.

Evaluation of the proportional hazards assumption and covariate adjustment methods in comparative surgical observational studies with time-to-event endpoints.

INTRODUCTION: Comparative studies on surgical treatments with time-to-event endpoints have provided substantial evidence for clinical practice, but the accurate use of survival data analysis and the control of confounding bias remain big challenges. METHODS: This was a survey of surgical studies with survival outcomes published in four general medical journals and five general surgical journals in 2021. The two most concerned statistical issues were evaluated, including confounding control by propensity score analysis (PSA) or multivariable analysis and testing of proportional hazards (PH) assumption in Cox model. RESULTS: A total of 74 studies were included, comprising 63 observational studies and 11 randomized controlled trials. Among the observational studies, the proportion of studies utilizing PSA in surgical oncology and non-oncology studies was similar (40.9 % versus 36.8 %, P = 0.762). However, the former reported a significantly lower proportion of PH assumption assessments compared to the latter (13.6 % versus 42.1 %, P = 0.020). Twenty-five observational studies (25/63) used PSA methods, but two-thirds of them (17/25) showed unclear balance of baseline data after PSA. And the proportion of PH assumption testing after PSA was slightly lower than that before PSA, but the difference was not statistically significant (24.0 % versus 28.0 %, P = 0.317). Comprehensive suggestions were given on confounding control in survival analysis and alternative resolutions for non-compliance with PH assumption. CONCLUSION: This study highlights suboptimal reporting of PH assumption evaluation in observational surgical studies both before and after PSA. Efforts and consensus are needed with respect to the underlying assumptions of statistical methods.

Bifocal solid pseudopapillary tumour of the pancreas.

Solid pseudopapillary neoplasm of the pancreas (SPNP) is a rare entity. In this study, we present a woman in her 20's who presented for evaluation of two separate pancreatic masses. On imaging and biopsy, the tail lesion was thought to be a neuroendocrine tumour and the body lesion was thought to be a metastatic lymph node. The patient was brought to the operating room and underwent a distal pancreatectomy and splenectomy. The patient had an uneventful postoperative course and was discharged home on postoperative day 4. Pathology confirmed both masses were consistent with the diagnosis of well-differentiated SPNP with no signs of malignancy including lymphovascular or perineural invasion, or lymph node involvement.

Molecular classification of endometrial carcinoma on endometrial biopsy: an early prognostic value to guide personalized treatment.

OBJECTIVE: Molecular features are essential for estimating the risk of recurrence and impacting overall survival in patients with endometrial cancer. Additionally, the surgical procedure itself could be personalized based on the molecular characteristics of the tumor. This study aims to assess the feasibility of obtaining reliable molecular classification status from biopsy specimens collected during hysteroscopy to better modulate the appropriate surgical treatment. METHODS: This monocentric, retrospective, observational study was conducted on 106 patients who underwent a biopsy procedure followed by radical surgery for endometrial cancer, with concurrent molecular investigation. The molecular classification was determined through immunohistochemical staining for p53 and mismatch repair proteins, along with gene sequencing for POLE. RESULTS: Overall, 106 patients underwent molecular investigation, which was finally achieved on 99 patients (93.4%). Among these, the molecular analysis was conducted in 71 patients (67%) on the pre-operative endometrial biopsy and on the final uterine specimen in 28 patients (26.4%). Most of the endometrial biopsies were performed using Bettocchi hysteroscopy (66%). Molecular analysis was not possible in seven patients (6.6%), with six cases due to sample inadequacy and one case attributed to intra-mucosal carcinoma. The molecular results showed that the copy number low sub-group was the most common, and five cases of 'multiple classifiers' were observed in the low-risk category. CONCLUSION: Our experience in obtaining molecular information from biopsy samples underscores the feasibility and efficacy of this technique, even in small tissue samples. This capability helps define the prognostic group of patients, facilitates timely decision-making, and develops a personalized strategy for each patient.

Use of social media for academic and professional purposes by gynecologic oncologists.

OBJECTIVE: To investigate the prevalence and patterns of social media use among gynecologic oncologists for professional and academic purposes. METHODS: A prospective online survey between November and December 2022 targeted gynecologic oncology practitioners (gynecologic oncologists, surgical oncologists, medical oncologists, radiation/clinical oncologists, and onco-pathologists/pathologists). The survey, distributed via various social media platforms, included 40 questions to capture qualitative and quantitative data on social media use. RESULTS: Of 131 respondents from 32 countries, 106 (80.9%) were gynecologic oncologists and affiliated with academic institutions (84.7%). Facebook (n=110, 83.9%), Twitter (n= 108, 82.4%), and Instagram (n=100, 76.3%) were the most used platforms. Respondents used social media to stay updated (n=101, 77.1%), network (n=97, 74%), learn about conferences and webinars (n=97, 74%), and engage in academic discussions (n=84, 64.1%). Following the COVID-19 pandemic, 100/129 (77.5%) reported increased social media use. However, only 32 (24.4%) used it to connect with patients, and concerns were raised about privacy and the need for separate professional and personal accounts. A quarter of respondents hesitated to share their opinions on social media due to the fear of controversy, with 26 (20%) experiencing cyberbullying, yet 120/130 (92.3%) believed it enabled junior professionals to express their views. Concerns about differentiating valid content, information reliability, and the professional perception of sourcing knowledge from social media were noted. Gender, age, specialty, and income level influenced patterns of social media use, with variations in preferences for platforms, content engagement, and purposes, highlighting a complex landscape of social media interaction among gynecologic oncologists. CONCLUSION: While the use of social media among gynecologic oncologists is prevalent, particularly for academic and professional development, challenges such as cyberbullying, privacy concerns, and the need for formal training in social media navigation persist. Tailored training programs and guidelines could enhance social media's effective and ethical use in this field, promoting a safe environment for professional expression and engagement.

Extramammary breast cancer of the vulva.

A woman in her 70s was seen in the gynaecology outpatient clinic with a swelling on the right side of the vulva. Surgical excision of the lesion revealed unexpectedly an extensive ductal carcinoma in situ with a focus of a grade 2 invasive ductal carcinoma arising in extramammary breast tissue of the vulva. Postoperative staging studies showed normal breasts, with no evidence of disease elsewhere. The patient underwent a wider excision of the right vulva and sentinel node biopsy of the right inguinal region, which revealed no further disease. The patient is currently taking adjuvant hormonal therapy and has remained disease free at 2-year follow-up. This case underscores the importance of considering rare presentations of vulvar malignancies and the necessity for a multidisciplinary approach in managing such cases.

The role of a dedicated Oncology Nurse Navigator in the surgical oncology pathways: 1 year experience from a General Surgery Unit in central Italy with follow up.

The Nurse Navigator is a highly specialized nurse with technical and non-technical skills that offers individualized assistance to cancer patients, their family and caregivers to overcome health system barriers and facilitate access to care. This role was introduced in the General Surgery Unit of the Madonna del Soccorso Hospital in San Benedetto del Tronto from 1st January 2023. The primary endpoint is to compare the times taken for each step of the diagnostic-therapeutic pathway comparing the study group followed by Oncology Nurse Navigator (ONN) and the group not followed by this role. The secondary endpoints, only for the study group, were the number of patient contacts with the ONN and the time slots; the number of examinations and consultations organized by ONN; the evaluation of patient satisfaction at discharge; the number and type of problems noted during follow-up contact at 7 and 30 days after discharge. A prospective court study with historical control was conducted from 1st January 2023 in Madonna del Soccorso Hospital, Italy. The study group consists of all cancer patients cared for by ONN. The control group was created by selecting the same number of patients as the study group but taken care of in the previous 3 years (from 2020 to 2022) and, therefore, without the presence of the Nurse Navigator. The control group data come from clinical documentation. The number and time slots of contact with the ONN were recorded through the use of a company mobile phone active 24/7 through phone calls and messages. The number of examinations and consultations is known through online requests. The satisfaction assessment was carried out through the use of externally validated questionnaire Patient Satisfaction with Cancer Care (PSCC). The follow-up was performed by telephone and recorded on documentation according to established parameters. A total of 200 patients were analyzed. Both the study and control groups included 100 patients each. The average time between the first contact with the patient and the execution of the diagnostic test was 7 days in the cases compared to 28 days in the control group. The waiting time for the Multi-Disciplinary Team discussion (MDT) was 3 days for the study group compared to 6 days in the control group. The average time taken for the first oncological visit was 3 days in the study group compared to 18 days in the controls. The time from first contact to the operating session was 20 days compared to 45 in controls. Each patient had an average of 10 phone calls with the ONN. For all patients accompanied at the first diagnosis, at least 2 radiological and laboratory tests were organized. Oncology appointment for treatment evaluations after delivery of the histological report was communicated within a maximum of 3 working days. A patient satisfaction questionnaire achieved a response rate of 100%, with an average score of 87.0/90. The telephone follow-up had a response rate of 100% of patients and revealed a decrease in problems at the 30-day check-up compared to that of 7 days after discharge. (Activity of Daily Living 20% vs 8%; nutritional problems 40% vs 21%, pain 18% vs 2%; surgical wounds 45% vs 1%; mobilization 8% vs 0%). The data demonstrate that ONN service improves the quality and outcomes of surgical oncology patients' pathway. The professional role of the ONN, with predefined technical and non-technical skills, should also be officially recognized by the healthcare system and hospital administration.

A pre-operative scoring model to estimate the risk of blood transfusion over an ovarian cancer debulking surgery (BLOODS score): a Memorial Sloan Kettering Cancer Center Team Ovary study.

OBJECTIVES: To develop a pre-operative tool to estimate the risk of peri-operative packed red blood cell transfusion in primary debulking surgery. METHODS: We retrospectively reviewed an institutional database to identify patients who underwent primary debulking surgery for ovarian cancer at a single center between January 1, 2001 and May 31, 2019. Receiver operating characteristic curve and area under the receiver operating characteristic curve (AUC) were calculated. Five-fold cross-validation was applied to the multivariate model. Significant variables were assigned a 'BLOODS' (BLood transfusion Over an Ovarian cancer Debulking Surgery) score of +1 if present. A total BLOODS score was calculated for each patient, and the odds of receiving a transfusion was determined for each score. RESULTS: Overall, 1566 patients met eligibility criteria; 800 (51%) underwent a peri-operative blood transfusion. Odds ratios (OR) were statistically significant for American Society of Anesthesiologists scores of 3 and 4 (OR 1.34, 95% confidence interval (95% CI) 1.09 to 1.63), pre-operative levels of cancer antigen 125 (CA125) (OR 2.43, 95% CI 1.98 to 2.99), platelets (OR 1.59, 95% CI 1.45 to 1.74), obesity (OR 0.76, 95% CI 0.60 to 0.96), presence of carcinomatosis (OR 2.45, 95% CI 1.93 to 3.11), bulky upper abdominal disease (OR 2.86, 95% CI 2.32 to 3.54), pre-operative serum albumin level (OR 0.31, 95% CI 0.24 to 0.40), and pre-operative hemoglobin level (OR 0.56, 95% CI 0.51 to 0.61). The corrected AUC was 0.748 (95% CI 0.693 to 0.804). BLOODS scores of 0 and 5 corresponded to 11% and 73% odds, respectively, of receiving a peri-operative blood transfusion. CONCLUSIONS: We developed a universal pre-operative scoring system, the BLOODS score, to help identify patients with ovarian cancer who would benefit from surgical planning and blood-saving techniques. The BLOODS score was directly proportional to the American Society of Anesthesiologists score, presence of upper abdominal disease, carcinomatosis, CA125 level, and platelets level. We believe this model can help physicians with surgical planning and can benefit patient outcomes.

Trimodal prehabilitation in oncogynaecology.

Prehabilitation is a set of interventions aimed at increasing the patient's endurance and functional capacity before a planned stressful event (oncogynaecological surgery). Currently, prehabilitation is based on three main modalities which are: physiotherapy, nutritional support and psychological support, with others gradually being added. In studies published to date, a positive effect of combined preoperative intervention on the patient's postoperative recovery reduces the risk of perioperative and postoperative complications, shortening the hospital stay. This directly reduces the costs associated with cancer treatment.

Re-evaluation of risk and oncological outcomes of resection of veins and arteries in the resection of pancreatic cancer.

BACKGROUND: Advances in chemotherapy have led to increasing major vascular resection during pancreatectomy which has been contraindicated due to high morbidity. This study aimed to verify the safety and oncological outcomes of vascular resection during pancreatectomy in the era of neoadjuvant therapy. METHODS: Data from patients who underwent surgery for pancreatic cancer at Seoul National University Hospital between 2001 and 2021 were reviewed. Clinicopathological outcomes were analyzed according vessel resection. A propensity-score-matched (PSM) analysis was performed to evaluate survival outcomes. RESULTS: Of 1596 patients, the proportion of those who underwent vascular resection increased from 9.2% to 23.4% over time divided into 5-year intervals. There were no differences in major complications (15.6% vs. 13.0%; p = .266) and 30-day mortality rate (0.3% vs. 0.6%; p = .837) between the vascular and nonvascular resection groups. After PSM, the vascular resection group demonstrated comparable survival outcome with the nonvascular resection group (5 year-survival-rate 20.4 vs. 23.7%; p = .194). Arterial resection yielded comparable survival outcome with nonvascular resection (5 year-survival-rate 38.1% vs. 23.7%; p = .138). CONCLUSIONS: Appropriate vascular resection-even arterial-is safe and effective in patients carefully selected for radical surgery in the era of neoadjuvant therapy. Further studies are needed to determine the optimal indication and method for vascular resection in patients with pancreatic cancer.

The Norwegian Watch and Wait study: Norwait for rectal cancer. A report from a failed study-a word of caution.

The paucity of prospective data on the subject of Watch and Wait for rectal cancer prompted the implementation of Norwait, a population-based study including rectal cancer patients after neoadjuvant therapy. The aim of the study was to assess the accuracy of clinical complete response (cCR) and quantify the regrowth rates. Norwait was a prospective population-based observational study with ethical approval (2017/935) registered at clinicaltrials.com (NTC03402477). Residents of Norway with histologically proven rectal cancer located within 15 cm from anal verge were eligible following completion of radiotherapy or chemoradiation at seven hospitals. cCR was the disappearance of tumour and of any ulcer with/without the appearance of whitening of prior tumour site and telangiectasia evaluated at 12 weeks by digital rectal exam, and endoscopic imaging. The study aimed to include 100 cCR patients with regrowth rates as primary endpoint. The data are presented in crude form. Eighty-two patients were included in seven hospitals from 2018 to 2020 when the study was terminated. Fifty-one patients were included in six hospitals, whereas protocol violations were identified in one hospital, where thirty-one (rather than protocol-estimated 12) patients were enrolled. Amongst the 31 patients, there were only 2 with documented cCR. Of the latter 29, there were 16 with ulcer or persistent tumour, and 13 without any documentation of cCR. Of these, 23 underwent surgery with a delay up to 50 weeks. At median 54-month follow-up of 31 patients, there were 77% local regrowths (n = 23), 40% metachronous metastases (n = 12) and 23% deaths (n = 7). At median 54-month follow-up of 51 cCR patients, there were 53% local regrowths (n = 27), 14% metachronous metastases (n = 7) and 4% deaths (n = 2). Norwait admonishes a word of caution reaching beyond the inconclusive results of a population-based study jeopardised by serious violation to protocol and legislation for conducting safe research.

Survival benefit associated with screening of patients at elevated risk for pancreatic cancer.

BACKGROUND & OBJECTIVES: Screening for pancreatic cancer is recommended for individuals with a strong family history, certain genetic syndromes, or a neoplastic cyst of the pancreas. However, limited data supports a survival benefit attributable to screening these higher-risk individuals. METHODS: All patients enrolled in screening at a High-Risk Pancreatic Cancer Clinic (HRC) from July 2013 to June 2020 were identified from a prospectively maintained institutional database and compared to patients evaluated at a Surgical Oncology Clinic (SOC) at the same institution during the same period. Clinical outcomes of patients selected for surgical resection, particularly clinicopathologic stage and overall survival, were compared. RESULTS: Among 826 HRC patients followed for a median (IQR) of 2.3 (0.8-4.2) years, 128 were selected for surgical resection and compared to 402 SOC patients selected for resection. Overall survival was significantly longer among HRC patients (median survival: not reached vs. 2.6 years, p < 0.001). Among 31 HRC and 217 SOC patients with a diagnosis of pancreatic ductal adenocarcinoma (PDAC), the majority of HRC patients were diagnosed with stage 0 disease (carcinoma in situ), while the majority of SOC patients were diagnosed with stage II disease (p < 0.001). Overall survival after resection of invasive PDAC was also significantly longer among HRC patients compared to SOC patients (median survival 5.5 vs. 1.6 years, p = 0.002). CONCLUSION: Patients at increased risk for PDAC and followed with guideline-based screening exhibited downstaging of disease and improved survival from PDAC in comparison to patients who were not screened.

Adult granulosa cell tumour camouflaged as mucinous neoplasm.

This case report delves into the diagnostic intricacies and clinical management of adult granulosa cell tumour (AGCT) in a woman in her 50s, presenting with pain abdomen. Initial imaging investigations like ultrasound suggested diagnosis of benign cystadenoma. Further MRI revealed a large well-defined multiloculated lesion so a diagnosis of neoplastic aetiology/likely mucinous cystadenocarcinoma was offered. However, the definitive diagnosis was established through meticulous histopathological examination, revealing characteristic features of AGCT, a rare ovarian neoplasm. The case underscores the diagnostic challenges posed by AGCT, the importance of integrating clinical, radiological and histopathological data, and the necessity for a multidisciplinary approach for accurate diagnosis and optimal patient management.

Development of an enhanced recovery after surgery program for pediatric solid tumors.

Introduction: Enhanced recovery after surgery (ERAS) is an evidence-based, multi-modal approach to decrease surgical stress, expedite recovery, and improve postoperative outcomes. ERAS is increasingly being utilized in pediatric surgery. Its applicability to pediatric patients undergoing abdominal tumor resections remains unknown. Methods and Analysis: A group of key stakeholders adopted ERAS principles and developed a protocol suitable for the variable complexity of pediatric abdominal solid tumor resections. A multi-center, prospective, propensity-matched case control study was then developed to evaluate the feasibility of the protocol. A pilot-phase was utilized prior to enrollment of all patients older than one month of age undergoing any abdominal, retroperitoneal, or pelvic tumor resections. The primary outcome was 90-day complications per patient. Additional secondary outcomes included: ERAS protocol adherence, length of stay, time to administration of adjuvant chemotherapy, readmissions, reoperations, emergency room visits, pain scores, opioid usage, and differences in Quality of Recovery 9 scores. Ethics and Dissemination: Institutional review board approval was obtained at all participating centers. Informed consent was obtained from each participating patient. The results of this study will be presented at pertinent society meetings and published in peer-reviewed journals. We expect the results will inform peri-operative care for pediatric surgical oncology patients and provide guidance on initiation of ERAS programs. We anticipate this study will take four years to meet accrual targets and complete follow-up. Trial Registration Number: NCT04344899.

Cross-fellowship Inter-institutional Exchange: Answering the Call for Hepatopancreatobiliary Training Standardization.

OBJECTIVE: General surgery trainees interested in performing hepatopancreatobiliary (HPB) surgery can choose from multiple fellowship pathways, namely HPB, surgical oncology (SO), and abdominal transplant-HPB (TXP-HPB). Although focused on similar operations, each program offers distinct clinical and technical emphases. DESIGN: An annual inter-institutional exchange between TXP-HPB and SO fellowships, starting in 2014. SETTING AND PARTICIPANTS: TXP-HPB fellows from Washington University in St. Louis (WUSTL) and SO fellows from Memorial Sloan Kettering Cancer Center (MSKCC). RESULTS: About 14 fellows have participated in the exchange so far, 13 of whom responded to our survey. At MSKCC, TXP-HPB fellows performed a median of 24 cases, including 6 major pancreatic resections, 3 major hepatectomies, 4 hepatic artery infusion pump insertions, and 1 major biliary case. At WUSTL, SO fellows performed a median of 16 cases, including 5 liver transplants, 2 major pancreatic resections, 2 major hepatectomies, and 2 major biliary cases. About 92.3% of respondents stated they would repeat the rotation, with SO fellows emphasizing the exposure to vascular anastomoses and transplant-HPB fellows appreciating the oncologic focus. CONCLUSIONS: A monthlong inter-institutional exchange offers a unique opportunity to standardize and improve HPB education.

Management of intramuscular melanoma metastases to the psoas.

We detail a case of a woman in her 40s with isolated melanoma skeletal muscle metastasis (MSMM) to the right psoas muscle. This patient underwent R0 surgical resection through a novel pelvic approach. She received subsequent adjuvant immunotherapy with Braftovi/Mektov along with adjuvant radiation. She is currently disease free at 9 months post surgery. Here, we describe our novel surgical approach including description of the tumour pathology. We explain our multidisciplinary management of MSMM consisting of a multidisciplinary surgical approach by surgical oncology, gynecological oncology and urology as well as multidisciplinary medical management by oncology, radiation oncology and pathology. Finally, we discuss best current options for therapeutic management.

Adjuvant external beam radiotherapy combined with brachytherapy for intermediate-risk cervical cancer.

OBJECTIVE: Patients with intermediate-risk cervical cancer receive external beam radiotherapy (EBRT) as adjuvant treatment. It is commonly administered with brachytherapy without proven benefits. Therefore, we evaluated the frequency of brachytherapy use, the doses for EBRT administered alone or with brachytherapy, and the overall survival impact of brachytherapy in patients with intermediate-risk, early-stage cervical cancer. METHODS: This retrospective cohort study was performed using data collected from the National Cancer Database. Patients diagnosed with cervical cancer from 2004 to 2019 who underwent a radical hysterectomy and lymph node staging and had disease limited to the cervix but with tumors larger than 4 cm or ranging from 2 to 4 cm with lymphovascular space invasion (LVSI) were included. Patients with distant metastasis or parametrial involvement were excluded. Patients who underwent EBRT alone were compared with those who also received brachytherapy after 2:1 propensity score matching. RESULTS: In total, 1174 patients met the inclusion criteria, and 26.7% of them received brachytherapy. After 2:1 propensity score matching, we included 620 patients in the EBRT group and 312 in the combination treatment group. Patients who received brachytherapy had higher equivalent doses than those only receiving EBRT. Overall survival did not differ between the two groups (hazard ratio (HR) 0.88 (95% confidence interval (CI), 0.62 to 1.23]; p=0.45). After stratification according to tumor histology, LVSI, and surgical approach, brachytherapy was not associated with improved overall survival. However, in patients who did not receive concomitant chemotherapy, the overall survival rate for those receiving EBRT and brachytherapy was significantly higher than that for those receiving EBRT alone (HR, 0.48 (95% CI, 0.27 to 0.86]; p=0.011). CONCLUSION: About one-fourth of the study patients received brachytherapy and EBRT. The variability in the doses and radiotherapy techniques used highlights treatment heterogeneity. Overall survival did not differ for EBRT with and without brachytherapy. However, overall survival was longer for patients who received brachytherapy but did not receive concomitant chemotherapy.

Frailty Increases Morbidity and Mortality in Patients Undergoing Oncological Liver Resections: A Systematic Review and Meta-analysis.

BACKGROUND: Considered to reflect a patients' biological age, frailty is a new syndrome shown to predict surgical outcomes in elderly patients. In view of the increasing age at which patients are proposed oncological liver surgery and the morbidity associated with it, we attempted to perform a systematic review and meta-analysis to compare morbidity and mortality between frail and nonfrail patients after liver resections. METHODS: The study was registered with PROSPERO. A systematic search of PubMed and EMBASE databases was performed for all comparative studies examining surgical outcomes after liver resections between frail and nonfrail patients. RESULTS: Ten studies were included based on the selection criteria with a total of 71,102 patients, split into two groups: frail (n = 17,167) and the control group (n = 53,928). There were more elderly patients with a lower preoperative albumin level in the frail group (p = 0.02, p = 0.001). Frail patients showed higher rates of morbidity with more major complications and a higher incidence of postoperative liver failure (p < 0.001). Mortality (p < 0.001) and readmission rate (p = 0.021) also was higher in frail patients. CONCLUSIONS: Frailty seems to be a solid predictive risk factor of morbidity and mortality after liver surgery and should be considered a selection criterion for liver surgery in at-risk patients.

A systematic methodology review of fluorescence-guided cancer surgery to inform the development of a core master protocol and outcome set.

BACKGROUND: Fluorescence-guided precision cancer surgery may improve survival and minimize patient morbidity. Efficient development of promising interventions is however hindered by a lack of common methodology. This methodology review aimed to synthesize descriptions of technique, governance processes, surgical learning and outcome reporting in studies of fluorescence-guided cancer surgery to provide guidance for the harmonized design of future studies. METHODS: A systematic search of MEDLINE, EMBASE and CENTRAL databases from 2016-2020 identified studies of all designs describing the use of fluorescence in cancer surgery. Dual screening and data extraction was conducted by two independent teams. RESULTS: Of 13,108 screened articles, 426 full text articles were included. The number of publications per year increased from 66 in 2016 to 115 in 2020. Indocyanine green was the most commonly used fluorescence agent (391, 91.8%). The most common reported purpose of fluorescence guided surgery was for lymph node mapping (195, 5%) and non-specific tumour visualization (94, 2%). Reporting about surgical learning and governance processes incomplete. A total of 2,577 verbatim outcomes were identified, with the commonly reported outcome lymph node detection (796, 30%). Measures of recurrence (32, 1.2%), change in operative plan (23, 0.9%), health economics (2, 0.1%), learning curve (2, 0.1%) and quality of life (2, 0.1%) were rarely reported. CONCLUSION: There was evidence of methodological heterogeneity that may hinder efficient evaluation of fluorescence surgery. Harmonization of the design of future studies may streamline innovation.