Radical surgery versus organ preservation via short-course radiotherapy followed by transanal endoscopic microsurgery for early-stage rectal cancer (TREC): a randomised, open-label feasibility study.
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SUBMITTER: Bach SP
PROVIDER: S-EPMC7802515 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundThe CARTS study is a multicenter feasibility study, investigating the role of rectum saving surgery for distal rectal cancer.Methods/designPatients with a clinical T1-3 N0 M0 rectal adenocarcinoma below 10 cm from the anal verge will receive neoadjuvant chemoradiation therapy (25 fractions of 2 Gy with concurrent capecitabine). Transanal Endoscopic Microsurgery (TEM) will be performed 8 - 10 weeks after the end of the preoperative treatment depending on the clinical response.Primary objective is to determine the number of patients with a (near) complete pathological response after chemoradiation therapy and TEM. Secondary objectives are the local recurrence rate and quality of life after this combined therapeutic modality. A three-step analysis will be performed after 20, 33 and 55 patients to ensure the feasibility of this treatment protocol.DiscussionThe CARTS-study is one of the first prospective multicentre trials to investigate the role of a rectum saving treatment modality using chemoradiation therapy and local excision. The CARTS study is registered at clinicaltrials.gov (NCT01273051).
| S-EPMC3295682 | biostudies-literature
Project description:ImportanceTreatment of rectal cancer is shifting toward organ preservation aiming to reduce surgery-related morbidity. Short-term outcomes of organ-preserving strategies are promising, but long-term outcomes are scarce in the literature.ObjectiveTo explore long-term oncological outcomes and health-related quality of life (HRQL) in patients with cT1-3N0M0 rectal cancer who underwent neoadjuvant chemoradiotherapy (CRT) followed by transanal endoscopic microsurgery (TEM).Design, setting, and participantsIn this multicenter phase II feasibility study, patients with cT1-3N0M0 rectal cancer admitted to referral centers for rectal cancer throughout the Netherlands between February 2011 and September 2012 were prospectively included. These patients were to be treated with neoadjuvant CRT followed by TEM in case of good response. An intensive follow-up scheme was used to detect local recurrences and/or distant metastases. Data from validated HRQL questionnaires and low anterior resection syndrome questionnaires were collected. Data were analyzed from February 2011 to April 2017.Main outcomes and measuresThe primary study outcome of the study was the number of ypT0-1 specimens by performing TEM. Secondary outcome parameters were locoregional recurrences and HRQL.ResultsOf the 55 included patients, 30 (55%) were male, and the mean (SD) age was 64 (39-82) years. Patients were followed up for a median (interquartile range) period of 53 (39-57) months. Two patients (4%) died during CRT, 1 (2%) stopped CRT, and 1 (2%) was lost to follow-up. Following CRT, 47 patients (85%) underwent TEM, of whom 35 (74%) were successfully treated with local excision alone. Total mesorectal excision was performed in 16 patients (4 with inadequate responses, 8 with completion after TEM, and 4 with salvage for local recurrence). The actuarial 5-year local recurrence rate was 7.7%, with 5-year disease-free and overall survival rates of 81.6% and 82.8%, respectively. Health-related quality of life during follow-up was equal to baseline, with improved emotional well-being in patients treated with local excision (mean score at baseline, 72.0; 95% CI, 67.1-80.1; mean score at follow-up, 86.9; 95% CI, 79.2-94.7; P = .001). Major, minor, and no low anterior resection syndrome was experienced in 50%, 28%, and 22%, respectively, of patients with successful organ preservation.Conclusions and relevanceIn early-stage rectal cancer (cT1-3N0M0), CRT enables organ preservation with additional TEM surgery in approximately two-thirds of patients with good long-term oncological outcome and HRQL. This multimodality treatment triggers a certain degree of bowel dysfunction, and one-third of patients still undergo radical surgery and are overtreated by CRT.
| S-EPMC6439861 | biostudies-literature
Project description:Transanal endoscopic microsurgery (TEM) is a minimally invasive technique that is increasingly being used to treat early rectal cancer (T1/T2). We studied the outcomes of TEM for rectal cancer at our institution looking at the indication, recurrence rate, need for further radical surgery, 30-day and 12-month mortality and complication rate. We performed a retrospective analysis of prospectively collected data of cases between 2008 and 2012: 110 TEM procedures were performed during this period: 40 were confirmed rectal cancers and 70 were benign. We analysed the data for the 40 patients with confirmed rectal cancer. Thirty (75 %) of the subjects were male with a mean age of 71?±?10 years (range 49-90 years) and 19 (48 %) patients were ASA 3 and 4. Nineteen (48 %) of cancers were pT1, eighteen (45 %) were pT2, two (5 %) were pT3 and one was yPT0. Mean specimen size was 66?±?20 mm (range 33-120 mm) with a mean polyp size of 41?±?24 mm (range 18-110 mm). The mean cancer size was 24?±?13 mm (range 2-50 mm). Average distance from the anal verge was 70?±?37 mm (range 10-150 mm), and the mean operating time was 72?±?22 min (range 40-120 min), with an average blood loss of 28?±?15 ml (range 10-50ml). Median hospital stay was 2?±?1 days (range 1-7 days). Complete excision (R0) was achieved in 37 (93 %) patients. Minor post-operative complications included urinary retention in two and pyrexia in three patients. There were no 30-day or 12-month mortalities. Mean follow-up was 13?±?11 months, range (3-40 months) Local recurrence occurred in two (5 %) patients, both underwent redo TEM. Twelve (30 %) patients underwent laparoscopic radical resections (seven AR and five APER) post-TEM. Post-operative histology confirmed pT0N0 in 7/12 patients. Three were lymph node-positive (T0N1), one was pT3N1 and the fifth was pT3N2. TEM is associated with quicker recovery, shorter hospital stay and fewer complications than radical surgery. It is a good alternative to radical surgery in early rectal cancer, especially for high-risk patients. Recurrent tumours can be treated with redo TEM.
| S-EPMC4775597 | biostudies-literature
Project description:PurposeLocal treatment of small well-differentiated rectal neuroendocrine tumors (NETs) is recommended by current guidelines. However, although several endoscopic methods have been established, the highest R0 rate is achieved by transanal endoscopic microsurgery (TEM). Since a recently published study about endoscopic full thickness resection (eFTR) showed a R0 resection rate of 100%, the aim of this study was to evaluate both methods (eFTR vs. TEM).MethodsWe retrospectively analyzed all patients with rectal NET treated either by TEM (1999-2018) or eFTR (2016-2019) in two tertiary centers (University Hospital Wuerzburg and Ulm). We analyzed clinical, procedural, and histopathological outcomes in both groups.ResultsTwenty-eight patients with rectal NET received local treatment (TEM: 13; eFTR: 15). Most tumors were at stage T1a and grade G1 or G2 (in the TEM group two G3 NETs were staged T2 after neoadjuvant chemotherapy). In both groups, similar outcomes for en bloc resection rate, R0 resection rate, tumor size, or specimen size were found. No procedural adverse events were noted. Mean procedure time in the TEM group was 48.9 min and 19.2 min in the eFTR group.ConclusioneFTR is a convincing method for local treatment of small rectal NETs combining high safety and efficacy with short interventional time.
| S-EPMC8026435 | biostudies-literature
Project description:BACKGROUND:Transanal minimally invasive surgery (TAMIS) is deployed for organ preservation in early rectal cancer and significant rectal polyps. Rapid evaporative ionisation mass spectrometry (REIMS) provides biochemical tissue analysis, which could be applied intraoperatively to give real-time tissue feedback to the surgeon and decrease the risk of an involved margin. However, the accuracy and feasibility of this approach have not been established. METHODS:In this prospective observational study, patients undergoing resection of rectal adenomas or carcinomas were recruited. An electrosurgical handpiece analysed tissues ex vivo using diathermy, with the aerosol aspirated into a Xevo G2-S ToF mass spectrometer. The relative abundance of lipids underwent predictive statistical modelling and leave-one-patient-out cross-validation. The outcomes of interest were the ability of REIMS to differentiate normal, adenomatous and cancerous tissue, or any disease subtype from normal. REIMS was coupled with TAMIS for in vivo sampling, assessing the accuracy of tissue recognition and distinguishing bowel wall layers. RESULTS:Forty-seven patients were included, yielding 266 spectra (121 normal, 109 tumour and 36 adenoma). REIMS differentiates normal, adenomatous and cancerous rectal tissues with 86.8% accuracy, and normal and adenomatous tissue with 92.4% accuracy and 91.4% accuracy when differentiating disease from normal. We have performed the first five in-man mass spectrometry augmented TAMIS (MS-TAMIS). In real time, MS-TAMIS can differentiate rectal mucosa and submucosa based on their relative abundance of triglycerides and glycerophospholipids. The ex vivo accuracy distinguishing diseased and normal tissues is maintained in vivo at 90%, with negative predictive value of 95%. The system identified a deep and lateral involved tumour margin during TAMIS. CONCLUSIONS:REIMS distinguishes rectal tissue types based on underlying lipid biology, and this can be translated in vivo by coupling it to TAMIS. There is a role for this technology in improving the efficacy of resection of early rectal cancers.
| S-EPMC7326832 | biostudies-literature
Project description:Transanal endoscopic microsurgery (TEM) for the treatment of early-stage rectal cancer has attracted attention due to its advantages of reduced surgical trauma, fewer complications, low operative mortality, rapid postoperative recovery and short hospital stay. However, there are still significant controversies regarding TEM for the treatment of rectal cancer, mainly related to the prognosis associated with this method.This study sought to compare the efficacy of transanal endoscopic microsurgery (TEM) and total mesorectal excision (TME) for the treatment of T1 rectal cancer.We searched the Cochrane Library, PubMed, Embase and CNKI databases. Based on the Cochrane Handbook for Systematic Reviews, we screened the trials, evaluated the quality and extracted the data.One randomized controlled trial (RCT) and six non-randomized controlled clinical trials (CCTs) were included in the meta-analysis (a total of 860 rectal cancer patients were included; 303 patients were treated with TEM, and 557 patients were treated with TME). Analysis revealed that all seven studies reported local recurrence rates, and there was a significant difference between the TEM and TME groups [odds ratio (OR) = 4.62, 95% confidence interval (CI) (2.03, 10.53), P = 0.0003]. A total of five studies reported distant metastasis rates, and there was no significant difference between the TEM and TME groups [OR = 0.74, 95%CI (0.32, 1.72), P = 0.49]. A total of six studies reported postoperative overall survival of the patients, and there was no significant difference between the TEM and TME groups [OR = 0.87, 95%CI(0.55, 1.38), P = 0.55]. In addition, two studies reported the postoperative disease-free survival rates of patients, and there was no significant difference between the TEM and TME groups [OR = 1.12, 95%CI (0.31, 4.12), P = 0.86].For patients with T1 rectal cancer, the distant metastasis, overall survival and disease-free survival rates did not differ between the TEM and TME groups, although the local recurrence rate after TEM was higher than that after TME.
| S-EPMC4624726 | biostudies-literature
Project description:A proportion of patients with rectal cancer who undergo neoadjuvant treatment end up with a complete pathological response. Because these patients have excellent oncological outcomes, many have questioned if surgical treatment in this population constitutes overtreatment. There is growing interest in watch and wait with selective organ preservation for rectal cancer patients. We review the fundamentals and key considerations of this approach including patient selection, available treatment regimens, assessment of response, long-term monitoring of response, and long-term oncological and functional outcomes.
| S-EPMC7390702 | biostudies-literature
Project description:INTRODUCTION: Transanal endoscopic microsurgery (TEM) is a minimal invasive technique for local excision of rectal tumours. The procedure is performed via a rectoscope with a diametre of 4 cm. The aim of this prospective study was to assess both functional outcome and quality of life after TEM. PATIENTS AND METHODS: Between 2004 and 2006, 47 patients were studied prior to and at least 6 months after TEM. Demographics, operative details and post-operative complications were recorded. Functional outcome was determined using the Faecal Incontinence Severity Index (FISI). Quality of life was measured using the EuroQol EQ-5D questionnaire and the Faecal Incontinence Quality of Life (FIQL) score. RESULTS: Six months after surgery, median FISI score was found to be decreased (p<0.01), depicting an improvement in faecal continence. This improvement was most significant in tumours within 7 cm from the dentate line (p=0.01). From the patients' perspective, post-operative quality of life was found to be higher (p<0.02). A significant improvement was observed in two of the four FIQLS domains (embarrassment, p=0.03; lifestyle, p=0.05). The domains of lifestyle, coping and behaviour and embarrassment were correlated with the FISI (all p<0.05). CONCLUSION: This study indicates TEM has no deteriorating effect on faecal continence. Moreover, once the tumour has been excised using TEM, quality of life is improved.
| S-EPMC2386752 | biostudies-other
Project description:AimOrgan-saving treatment for early-stage rectal cancer can reduce patient-reported side effects compared to standard total mesorectal excision (TME) and preserve quality of life. An optimal strategy for achieving organ preservation and longer-term oncological outcomes are unknown; thus there is a need for high quality trials.MethodCan we Save the rectum by watchful waiting or TransAnal surgery following (chemo)Radiotherapy versus Total mesorectal excision for early REctal Cancer (STAR-TREC) is an international three-arm multicentre, partially randomized controlled trial incorporating an external pilot. In phase III, patients with cT1-3b N0 tumours, ≤40 mm in diameter, who prefer organ preservation are randomized 1:1 between mesorectal long-course chemoradiation versus mesorectal short-course radiotherapy, with selective transanal microsurgery. Patients preferring radical surgery receive TME. STAR-TREC aims to recruit 380 patients to organ preservation and 120 to TME surgery. The primary outcome is the rate of organ preservation at 30 months. Secondary clinician-reported outcomes include acute treatment-related toxicity, rate of non-operative management, non-regrowth pelvic tumour control at 36 months, non-regrowth disease-free survival at 36 months and overall survival at 60 months, and patient-reported toxicity, health-related quality of life at baseline, 12 and 24 months. Exploratory biomarker research uses circulating tumour DNA to predict response and relapse.DiscussionSTAR-TREC will prospectively evaluate contrasting therapeutic strategies and implement new measures including a smaller mesorectal target volume, two-step response assessment and non-operative management for complete response. The trial will yield important information to guide routine management of patients with early-stage rectal cancer.
| S-EPMC9311773 | biostudies-literature
Project description:BackgroundThe treatment of flat rectal adenomas is challenging. The technical difficulty and the potential of malignancy in suspected benign lesions are the factors in question. Surgical and interventional endoscopic techniques are implemented in Europe without a clear strategy. To minimize recurrent adenoma and unclear histopathological work up en bloc excision is desirable.Methods and resultsWe demonstrate in this article the transanal endoscopic microsurgical submucosa dissection (TEM-ESD) procedure as a feasible method for en bloc excision of rectal adenomas and early rectal cancer. The surgical technique is demonstrated in detail with the help of a video of the operation that is available online. The results of a consecutive series of 78 patients are presented.ConclusionTEM-ESD is a safe procedure for resection of rectal adenomas and low risk carcinomas. It offers the possibility of organ preservation and minimizes functional disturbances. In case of a necessary salvage operation, the preserved integrity of the rectal muscle tube grants maximal oncological safety.
| S-EPMC6208633 | biostudies-literature