As current follow-up modalities for colorectal carcinoma (CRC) have restricted sensitivity, novel diagnostic tools are needed. The presence of CRC changes the endogenous metabolism, resulting in the release of a specific volatile organic compounds (VOC) pattern that can be detected with an electronic nose or Aeonose^TM. To evaluate the use of an electronic nose in the follow-up of CRC, we studied the effect of curative surgery on the VOC pattern recognition using Aeonose^TM. A prospective cohort study was performed, in which 47 patients diagnosed with CRC were included, all of whom underwent curative surgical resection. Breath testing was performed before and after surgery using the Aeonose^TM. A machine learning model was developed by discerning between the 94 pre-and postoperative breath samples. The training model differentiated between the pre-and postoperative CRC breath samples with a sensitivity and specificity of 0.78 (95%CI 0.61–0.90) and 0.73 (95%CI 0.56–0.86), respectively, with an accuracy of 0.76 (95%CI 0.66–0.85), and an area under the curve of 0.79 (95%CI 0.68–0.89). The internal validation of the test set resulted in an accuracy of 0.75 (95%CI 0.51–0.91) and AUC of 0.82 (95%CI 0.61–1). In conclusion, our results suggest that the VOC pattern of CRC patients is altered by curative surgery in a short period, indicating that the exhaled VOCs might be closely related to the presence of CRC. However, to use Aeonose^TM as a potential diagnostic tool in the clinical follow-up of CRC patients, the performance of the models needs to be improved through further large-scale prospective research.

The sole presence of deep submucosal invasion is shown to be associated with a limited risk of lymph node metastasis. This justifies a local excision of suspected deep submucosal invasive colon carcinomas (T1 CCs) as a first step treatment strategy. Recently Colonoscopy-Assisted Laparoscopic Wedge Resection (CAL-WR) has been shown to be able to resect pT1 CRCs with a high R0 resection rate, but the long term outcomes are lacking. The aim of this study is to evaluate the safety, effectiveness and long-term oncological outcomes of CAL-WR as primary treatment for patients with suspected superficial and also deeply-invasive T1 CCs. In this prospective multicenter clinical trial, patients with a macroscopic and/or histologically suspected T1 CCs will receive CAL-WR as primary treatment in order to prevent unnecessary major surgery for low-risk T1 CCs. To make a CAL-WR technically feasible, the tumor may not include > 50% of the circumference and has to be localized at least 25 cm proximal from the anus. Also, there should be sufficient distance to the ileocecal valve to place a linear stapler. Before inclusion, all eligible patients will be assessed by an expert panel to confirm suspicion of T1 CC, estimate invasion depth and subsequent advise which local resection techniques are possible for removal of the lesion. The primary outcome of this study is the proportion of patients with pT1 CC that is curatively treated with CAL-WR only and in whom thus organ-preservation could be achieved. Secondary outcomes are 1) CAL-WR’s technical success and R0 resection rate for T1 CC, 2) procedure-related morbidity and mortality, 3) 5-year overall and disease free survival, 4) 3-year metastasis free survival, 5) procedure-related costs and 6) impact on quality of life. A sample size of 143 patients was calculated. CAL-WR is a full-thickness local resection technique that could also be effective in removing pT1 colon cancer. With the lack of current endoscopic local resection techniques for > 15 mm pT1 CCs with deep submucosal invasion, CAL-WR could fill the gap between endoscopy and major oncologic surgery. The present study is the first to provide insight in the long-term oncological outcomes of CAL-WR. CCMO register (ToetsingOnline), NL81497.075.22, protocol version 2.3 (October 2022).

BACKGROUND: The LIMERIC study has proven that colonoscopy-assisted laparoscopic wedge resection effectively and safely removes benign colonic lesions unsuitable for endoscopic removal, thereby avoiding the need for major surgery. OBJECTIVE: To evaluate the impact of colonoscopy-assisted laparoscopic wedge on health-related quality of life of patients who participated in the LIMERIC study. DESIGN: Prospective multicenter study. SETTINGS: The LIMERIC study was performed between 2016 and 2020 in 13 Dutch hospitals. Five-level EuroQoL 5-dimension questionnaires were administered at baseline and 3 months after the procedure. PATIENTS: Patients with incomplete pre- or postoperative questionnaires or those undergoing combined interventions were excluded from the intention-to-treat analysis. Those for whom CAL-WR was not feasible or who underwent completion surgery were excluded from the per-protocol analysis. INTERVENTION: Colonoscopy-assisted laparoscopic wedge for either 1) colon polyp unsuitable for endoscopic resection; 2) nonlifting residual or recurrent polyp within scar tissue after previous polypectomy; or (3) Rx/R1 endoscopic removal of a low-risk pT1 colon carcinoma. MAIN OUTCOME MEASURES: Three-month health-related quality of life. RESULTS: Colonoscopy-assisted laparoscopic wedge did not affect health-related quality of life in the per-protocol analysis (n = 56) or in the intention-to-treat analysis (n = 67). The majority of patients reported no change in health status (57%). No significant differences were observed in the distribution of responses across all 5 dimensions before and after colonoscopy-assisted laparoscopic wedge. Patients’EuroQoL self-rated visual analog scale scores were also unaffected by a colonoscopy-assisted laparoscopic wedge, with a median score of 82.5 at baseline and 80 after surgery in the per-protocol analysis (p = 0.63). LIMITATIONS: Solely a patient-reported outcome measure evaluating global health-related quality of life was used, rather than one specifically assessing disease-related quality of life, such as the quality of life questionnaire colorectal cancer module 29. CONCLUSIONS: Colonoscopy-assisted laparoscopic wedge has no significant impact on the health-related quality of life in patients with benign colonic lesions and should therefore be considered before major surgery is performed. See Video Abstract. RESECCIÓN LAPAROSCÓPICA EN CUÑA ASISTIDA POR COLONOSCOPIA PARA LESIONES COLÓNICAS: IMPACTO EN LA CALIDAD DE VIDA: RESULTADOS DEL ESTUDIO LIMERIC: ANTECEDENTES: El estudio LIMERIC ha demostrado que la resección laparoscópica en cuña asistida por colonoscopia elimina de forma eficaz y segura las lesiones colónicas benignas inadecuadas para la extirpación endoscópica, evitando así la necesidad de cirugía mayor. OBJETIVO: Evaluar el impacto de la cuña laparoscópica asistida por colonoscopia en la calidad de vida relacionada con la salud de los pacientes que participaron en el estudio LIMERIC. DISEÑO: Estudio multicéntrico prospectivo. ENTORNO: El estudio LIMERIC se realizó entre 2016 y 2020 en 13 hospitales holandeses. Se administraron cuestionarios EQ-5D-5L al inicio y 3 meses después del procedimiento. PACIENTES: Los pacientes con cuestionarios pre o postoperatorios incompletos o aquellos sometidos a intervenciones combinadas fueron excluidos del análisis por intención de tratar. Aquellos en los que la CAL-WR no era factible o que se sometieron a cirugía de finalización fueron excluidos del análisis por protocolo. INTERVENCIÓN: Cuña laparoscópica asistida por colonoscopia para (1) pólipo de colon no apto para resección endoscópica; (2) pólipo residual o recidivante no elevable dentro de tejido cicatricial tras polipectomía previa; o (3) extirpación endoscópica Rx/R1 de un carcinoma de colon pT1 de bajo riesgo. MEDIDAS DE RESULTADO PRINCIPALES: Calidad de vida relacionada con la salud a los tres meses. RESULTADOS: La cuña laparoscópica asistida por colonoscopia no afectó a la calidad de vida relacionada con la salud en el análisis por protocolo (n = 56), ni en el análisis por intención de tratar (n = 67). La mayoría de los pacientes no informaron ningún cambio en su estado de salud (57%). No se observaron diferencias significativas en la distribución de las respuestas en las 5 dimensiones antes y después de la cuña laparoscópica asistida por colonoscopia. La EQ-VAS autoevaluada de los pacientes tampoco se vio afectada por la cuña laparoscópica asistida por colonoscopia, con una puntuación media de la VAS de 82,5 al inicio y 80 después de la cirugía en el análisis por protocolo (p = 0,63). LIMITACIONES: Se utilizó únicamente una medida de resultados comunicada por el paciente que evaluaba la calidad de vida global relacionada con la salud, en lugar de una que evaluara específicamente la calidad de vida relacionada con la enfermedad, como el QLQ-CR29. CONCLUSIONES: La cuña laparoscópica asistida por colonoscopia no tiene un impacto significativo en la calidad de vida relacionada con la salud en pacientes con lesiones colónicas benignas y, por lo tanto, debe considerarse antes de realizar una cirugía mayor. (Traducción—Dr. Aurian Garcia Gonzalez)