Long-term oncological outcomes of endoscopic full-thickness resection after previous incomplete resection of low-risk T1 CRC (LOCAL-study): study protocol of a national prospective cohort study.

BACKGROUND: T1 colorectal cancer (CRC) without histological high-risk factors for lymph node metastasis (LNM) can potentially be cured by endoscopic resection, which is associated with significantly lower morbidity, mortality and costs compared to radical surgery. An important prerequisite for endoscopic resection as definite treatment is the histological confirmation of tumour-free resection margins. Incomplete resection with involved (R1) or indeterminate (Rx) margins is considered a strong risk factor for residual disease and local recurrence. Therefore, international guidelines recommend additional surgery in case of R1/Rx resection, even in absence of high-risk factors for LNM. Endoscopic full-thickness resection (eFTR) is a relatively new technique that allows transmural resection of colorectal lesions. Local scar excision after prior R1/Rx resection of low-risk T1 CRC could offer an attractive minimal invasive strategy to achieve confirmation about radicality of the previous resection or a second attempt for radical resection of residual luminal cancer. However, oncologic safety has not been established and long-term data are lacking. Besides, surveillance varies widely and requires standardization. METHODS/DESIGN: In this nationwide, multicenter, prospective cohort study we aim to assess feasibility and oncological safety of completion eFTR following incomplete resection of low-risk T1 CRC. The primary endpoint is to assess the 2 and 5 year luminal local tumor recurrence rate. Secondary study endpoints are to assess feasibility, percentage of curative eFTR-resections, presence of scar tissue and/or complete scar excision at histopathology, safety of eFTR compared to surgery, 2 and 5 year nodal and/or distant tumor recurrence rate and 5-year disease-specific and overall-survival rate. DISCUSSION: Since the implementation of CRC screening programs, the diagnostic rate of T1 CRC is steadily increasing. A significant proportion is not recognized as cancer before endoscopic resection and is therefore resected through conventional techniques primarily reserved for benign polyps. As such, precise histological assessment is often hampered due to cauterization and fragmentation and frequently leads to treatment dilemmas. This first prospective trial will potentially demonstrate the effectiveness and oncological safety of completion eFTR for patients who have undergone a previous incomplete T1 CRC resection. Hereby, substantial surgical overtreatment may be avoided, leading to treatment optimization and organ preservation. Trial registration Nederlands Trial Register, NL 7879, 16 July 2019 ( https://trialregister.nl/trial/7879 ).

[Pancreatic cystic neoplasms: a clinical dilemma]. / Neoplastische cysten van het pancreas.

Pancreatic cystic neoplasms are increasingly detected in the general population. Although most of these lesions are benign, some are (pre)malignant and require follow-up or even surgical intervention. Three cases are presented and used to discuss the clinical implications of the renewed European Guideline on pancreatic cystic neoplasms in which relative and absolute indications for resection are proposed. In the first case, a pancreatic cystic lesion was found on abdominal ultrasound in a 77-year old female patient. After endoscopic ultrasound was performed, a serous cystic neoplasm was diagnosed without need for surveillance. In a 57-year old male, an abdominal MRI was performed to further assess an incidentally found pancreatic cystic lesion. Based on the MRI, a side-branch intraductal papillary mucinous neoplasm (SB-IPMN) was diagnosed and yearly surveillance was initiated. A 61-year old male underwent a laparoscopic distal pancreatectomy because of a mixed-type IPMN (MT-IPMN). The pathological results showed an IPMN with high-grade dysplasia.

Pain patterns in chronic pancreatitis: a nationwide longitudinal cohort study.

OBJECTIVE: Pain in chronic pancreatitis is subdivided in a continuous or intermittent pattern, each thought to represent a different entity, requiring specific treatment. Because evidence is missing, we studied pain patterns in a prospective longitudinal nationwide study. DESIGN: 1131 patients with chronic pancreatitis (fulfilling M-ANNHEIM criteria) were included between 2011 and 2018 in 30 Dutch hospitals. Patients with continuous or intermittent pain were compared for demographics, pain characteristics, quality of life (Short-Form 36), imaging findings, disease duration and treatment. Alternation of pain pattern and associated variables were longitudinally assessed using a multivariable multinomial logistic regression model. RESULTS: At inclusion, 589 patients (52%) had continuous pain, 231 patients (20%) had intermittent pain and 311 patients (28%) had no pain. Patients with continuous pain had more severe pain, used more opioids and neuropathic pain medication, and had a lower quality of life. There were no differences between pain patterns for morphological findings on imaging, disease duration and treatment. During a median follow-up of 47 months, 552 of 905 patients (61%) alternated at least once between pain patterns. All alternations were associated with the Visual Analogue Scale pain intensity score and surgery was only associated with the change from pain to no pain. CONCLUSION: Continuous and intermittent pain patterns in chronic pancreatitis do not seem to be the result of distinctly different pathophysiological entities. The subjectively reported character of pain is not related to imaging findings or disease duration. Pain patterns often change over time and are merely a feature of how severity of pain is experienced.

European guidelines on achalasia: United European Gastroenterology and European Society of Neurogastroenterology and Motility recommendations.

INTRODUCTION: Achalasia is a primary motor disorder of the oesophagus characterised by absence of peristalsis and insufficient lower oesophageal sphincter relaxation. With new advances and developments in achalasia management, there is an increasing demand for comprehensive evidence-based guidelines to assist clinicians in achalasia patient care. METHODS: Guidelines were established by a working group of representatives from United European Gastroenterology, European Society of Neurogastroenterology and Motility, European Society of Gastrointestinal and Abdominal Radiology and the European Association of Endoscopic Surgery in accordance with the Appraisal of Guidelines for Research and Evaluation II instrument. A systematic review of the literature was performed, and the certainty of the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation methodology. Recommendations were voted upon using a nominal group technique. RESULTS: These guidelines focus on the definition of achalasia, treatment aims, diagnostic tests, medical, endoscopic and surgical therapy, management of treatment failure, follow-up and oesophageal cancer risk. CONCLUSION: These multidisciplinary guidelines provide a comprehensive evidence-based framework with recommendations on the diagnosis, treatment and follow-up of adult achalasia patients.

Recurrence of idiopathic acute pancreatitis after cholecystectomy: systematic review and meta-analysis.

BACKGROUND: Occult biliary disease has been suggested as a frequent underlying cause of idiopathic acute pancreatitis (IAP). Cholecystectomy has been proposed as a strategy to prevent recurrent IAP. The aim of this systematic review was to determine the efficacy of cholecystectomy in reducing the risk of recurrent IAP. METHODS: PubMed, Embase and Cochrane Library databases were searched systematically for studies including patients with IAP treated by cholecystectomy, with data on recurrence of pancreatitis. Studies published before 1980 or including chronic pancreatitis and case reports were excluded. The primary outcome was recurrence rate. Quality was assessed using the Newcastle-Ottawa Scale. Meta-analyses were undertaken to calculate risk ratios using a random-effects model with the inverse-variance method. RESULTS: Overall, ten studies were included, of which nine were used in pooled analyses. The study population consisted of 524 patients with 126 cholecystectomies. Of these 524 patients, 154 (29·4 (95 per cent c.i. 25·5 to 33·3) per cent) had recurrent disease. The recurrence rate was significantly lower after cholecystectomy than after conservative management (14 of 126 (11·1 per cent) versus 140 of 398 (35·2 per cent); risk ratio 0·44, 95 per cent c.i. 0·27 to 0·71). Even in patients in whom IAP was diagnosed after more extensive diagnostic testing, including endoscopic ultrasonography or magnetic resonance cholangiopancreatography, the recurrence rate appeared to be lower after cholecystectomy (4 of 36 (11 per cent) versus 42 of 108 (38·9 per cent); risk ratio 0·41, 0·16 to 1·07). CONCLUSION: Cholecystectomy after an episode of IAP reduces the risk of recurrent pancreatitis. This implies that current diagnostics are insufficient to exclude a biliary cause.

ANTECEDENTES: Se ha sugerido que la enfermedad biliar oculta es una causa subyacente frecuente de pancreatitis aguda idiopática (idiopathic acute pancreatitis, IAP). La colecistectomía se ha propuesto como una estrategia para prevenir la IAP recidivante. El objetivo de esta revisión sistemática era determinar la eficacia de la colecistectomía para reducir el riesgo de la IAP recidivante. MÉTODOS: Se realizó una búsqueda sistemática en PubMed, Embase y Cochrane de estudios que incluían pacientes con IAP tratados con colecistectomía, y con datos sobre la recidiva de la pancreatitis. Se excluyeron los estudios anteriores a 1980, los que incluían pancreatitis crónica y los casos clínicos. El resultado principal fue la tasa de recidiva. La calidad se evaluó utilizando la escala de Newcastle-Ottawa. Se realizaron metaanálisis para calcular la tasa de riesgo utilizando un modelo de efectos aleatorios con el método de varianza inversa. RESULTADOS: En total, se incluyeron 10 estudios, de los cuales 9 se utilizaron para realizar análisis agrupados. La población de estudio incluyó 524 pacientes en los que se habían efectuado 126 colecistectomías. De estos 524 pacientes, 154 (29% (i.c. del 95% 25,5-33,3)) presentaron recidiva de la enfermedad. La tasa de recidiva fue significativamente menor después de la colecistectomía que después del tratamiento conservador (14/126 (11%) versus 140/398 (35)); tasa de riesgo 0,44 (i.c. del 95% 0,27-0,71)). Incluso en pacientes en los que se diagnosticó IAP tras haber efectuado pruebas diagnósticas más extensas, incluyendo ultrasonografía endoscópica o colangiopancreatografía por resonancia magnética, la tasa de recidiva después de la colecistectomía era menor (4/36 (11%) versus 42/108 (39%); tasa de riesgo 0,41 (i.c. del 95% 0,16-1,07)). CONCLUSIÓN: La práctica de una colecistectomía después de un episodio de IAP disminuye el riesgo de pancreatitis recidivante. Esto implica que los diagnósticos actuales son insuficientes para excluir una causa biliar (PROSPERO CRD42017055275).

Surveillance for pancreatic cancer in high-risk individuals.

Background: Surveillance of individuals at high risk of pancreatic ductal adenocarcinoma (PDAC) and its precursors might lead to better outcomes. The aim of this study was to determine the prevalence and outcomes of PDAC and high-risk neoplastic precursor lesions among such patients participating in surveillance programmes. Methods: A multicentre study was conducted through the International CAncer of the Pancreas Screening (CAPS) Consortium Registry to identify high-risk individuals who had undergone pancreatic resection or progressed to advanced PDAC while under surveillance. High-risk neoplastic precursor lesions were defined as: pancreatic intraepithelial neoplasia (PanIN) 3, intraductal papillary mucinous neoplasia (IPMN) with high-grade dysplasia, and pancreatic neuroendocrine tumours at least 2 cm in diameter. Results: Of 76 high-risk individuals identified in 11 surveillance programmes, 71 had undergone surgery and five had been diagnosed with inoperable PDAC. Of the 71 patients who underwent resection, 32 (45 per cent) had PDAC or a high-risk precursor (19 PDAC, 4 main-duct IPMN, 4 branch-duct IPMN, 5 PanIN-3); the other 39 patients had lesions thought to be associated with a lower risk of neoplastic progression. Age at least 65 years, female sex, carriage of a gene mutation and location of a lesion in the head/uncinate region were associated with high-risk precursor lesions or PDAC. The survival of high-risk individuals with low-risk neoplastic lesions did not differ from that in those with high-risk precursor lesions. Survival was worse among patients with PDAC. There was no surgery-related mortality. Conclusion: A high proportion of high-risk individuals who had surgical resection for screening- or surveillance-detected pancreatic lesions had a high-risk neoplastic precursor lesion or PDAC at the time of surgery. Survival was better in high-risk individuals who had either low- or high-risk neoplastic precursor lesions compared with that in patients who developed PDAC.

Antecedentes: Se podrían obtener mejores resultados con el seguimiento de individuos de alto riesgo para adenocarcinoma ductal pancreático (pancreatic ductal adenocarcinoma, PDAC) y lesiones precursoras. El objetivo de este estudio fue determinar la prevalencia y los resultados del PDAC y de las lesiones precursoras de alto riesgo neoplásico en pacientes que participaron en programas de seguimiento. Métodos: Se llevó a cabo un estudio multicéntrico a través del registro internacional del consorcio CAPS (Common Automotive Platform Standard) para identificar a las personas de alto riesgo que se habían sometido a una resección pancreática o habían progresado a PDAC avanzado mientras estaban en seguimiento. Se definieron como lesiones neoplásicas precursoras de alto riesgo la neoplasia intraepitelial pancreática de tipo 3 (PanIN­3), la neoplasia papilar mucinosa intraductal (intraductal papillary mucinous neoplasia, IPMN) con displasia de alto grado y los tumores neuroendocrinos pancreáticos (pancreatic neuroendocrine tumours, PanNET) de ≥ 2 cm de diámetro. Resultados: De 76 individuos con lesiones de alto riesgo identificados en 11 programas de seguimiento, 71 fueron tratados quirúrgicamente y 5 fueron diagnosticados de un PDAC inoperable. De las 71 resecciones, 32 (45%) tenían PDAC o una lesión precursora de alto riesgo (19 PDAC, 4 IPMN de conducto principal, 4 IPMN de rama secundaria y 5 PanIN­3). Los otros 39 pacientes tenían lesiones que se consideraron asociadas con un menor riesgo de progresión neoplásica. La edad ≥ 65 años, el sexo femenino, el ser portador de una mutación genética y la localización de la lesión en la cabeza/proceso uncinado fueron factores asociados a las lesiones precursoras de alto riesgo o al PDAC. No hubo diferencias en la supervivencia de individuos de alto riesgo con lesiones neoplásicas de bajo riesgo frente a aquellos que presentaron lesiones precursoras de alto riesgo. La supervivencia fue peor en los pacientes con PDAC. No hubo mortalidad relacionada con la cirugía. Conclusión: Un elevado porcentaje de individuos de alto riesgo que se sometieron a resección quirúrgica tras la detección de lesiones pancreáticas en el seguimiento tenían una lesión precursora neoplásica de alto riesgo o un PDAC. La supervivencia fue mejor en individuos de alto riesgo que tenían lesiones precursoras neoplásicas de bajo o alto riesgo en comparación con aquellos pacientes que habían desarrollado un PDAC.

Multicentre study of surgical referral and outcomes of patients with benign colorectal lesions.

Background: A multicentre cohort study was performed to analyse the motivations for surgical referral of patients with benign colorectal lesions, and to evaluate the endoscopic and pathological characteristics of these lesions as well as short-term surgical outcomes. Methods: Patients who underwent surgery for a benign colorectal lesion in 15 Dutch hospitals between January 2014 and December 2017 were selected from the pathology registry. Lesions were defined as complex when at least one of the following features was present: size at least 40 mm, difficult location according to the endoscopist, previous failed attempt at resection, or non-lifting sign. Results: A total of 358 patients were included (322 colonic and 36 rectal lesions). The main reasons for surgical referral of lesions in the colon and rectum were large size (33·5 and 47 per cent respectively) and suspicion of invasive growth (31·1 and 58 per cent). Benign lesions could be categorized as complex in 80·6 per cent for colonic and 80 per cent for rectal locations. Surgery consisted of local excision in 5·9 and 64 per cent of colonic and rectal lesions respectively, and complicated postoperative course rates were noted in 11·2 and 3 per cent. In the majority of patients, no attempt was made to resect the lesion endoscopically (77·0 per cent of colonic and 83 per cent of rectal lesions). Conclusion: The vast majority of the benign lesions referred for surgical resection could be classified as complex. Considering the substantial morbidity of surgery for benign colonic lesions, reassessment for endoscopic resection by another advanced endoscopy centre seems to be underused and should be encouraged.

Antecedentes: Se realizó un estudio de cohorte multicéntrico para analizar los motivos de la derivación quirúrgica de pacientes con lesiones colorrectales benignas y evaluar las características endoscópicas y patológicas de estas lesiones, así como los resultados quirúrgicos a corto plazo. Métodos: A partir de un registro anatomopatológico, se seleccionaron los pacientes que se sometieron a cirugía por una lesión colorrectal benigna en 15 hospitales holandeses entre enero de 2014 y diciembre de 2017. Se definió como lesión compleja aquella que presentaba, al menos, una de las siguientes características: tamaño > 40 mm, ubicación difícil según el endoscopista, fracaso previo de la resección o signo de no­elevación. Resultados: Se incluyeron 358 pacientes (322 lesiones de colon y 36 rectales). Las principales razones para la derivación quirúrgica de las lesiones de colon y recto fueron el gran tamaño (34% y 47%) y la sospecha de crecimiento invasivo (31% y 58%). Las lesiones benignas se consideraron complejas en el 81% de los casos del colon y en el 80% del recto. La cirugía consistió en una exéresis local en el 6% y el 64% y se observó una tasa de complicaciones postoperatorias del 11% y el 3% de las lesiones de colon y recto, respectivamente. En la mayoría de los casos, no se intentó la resección endoscópica de la lesión (77% en colon y 83% en recto). Conclusión: La gran mayoría de las lesiones benignas derivadas para la resección quirúrgica podrían clasificarse como complejas. Considerando la notable morbilidad de la cirugía de las lesiones benignas de colon, debería contemplarse y fomentarse la reevaluación de la resección endoscópica en un centro de endoscopia avanzada.

The diagnostic yield of open-access endoscopy of the upper gastrointestinal tract in the Netherlands.

BACKGROUND AND STUDY AIMS: Since the introduction of open-access esophago-gastroduodenoscopy (OAE) there is an increase in the total number of performed OAEs whilst the frequency of clinical relevant findings has decreased. The aim of this study was to assess the appropriate use and the diagnostic yield of OAE in the Netherlands and to determine which patient variables are able to predict a malignant finding. PATIENTS AND METHODS: A retrospective chart review of all referrals for diagnostic OAE between October 2012 and October 2016 at the Northwest Clinics was performed. The indications were recorded from the referral letter and were classified as "appropriate" or "inappropriate" according to the NHG guideline. Logistic regression was used to detect significant predictive variables for a malignancy. RESULTS: A total of 2006 patients were included, of whom 59.6 % had an 'appropriate' referral indication. The diagnostic yield of finding a clinical relevant finding was significantly higher for OAEs with an "appropriate" referral indication. Independent risk factors for malignancy were alarm symptoms, age and male gender with a combined AUC of 0.868. CONCLUSIONS: Only 3.8 % of the malignancies would be missed by strict adherence to the guideline. This indicates that the open-access system in the Netherlands works well. Further improvement of the system can be achieved by only accepting appropriate indications for OAE and by treating patients under the age of 40 without OAE. We showed that a risk-prediction model based on the variables age, alarm symptoms and male gender is a good predictor of malignant finding.

Organizing and implementing a multidisciplinary fast track oncology clinic.

QUALITY PROBLEM: Patients with gastrointestinal malignancies often need multiple appointments with different medical specialists, causing waiting times to accrue. INITIAL ASSESSMENT: In our hospital, care is organized in a sequential manner, causing long waiting times. To reduce this, a fast track outpatient clinic (FTC) was implemented. CHOICE OF SOLUTION: The FTC was organized within the hospital's existing structure. Patient centered care was achieved by ensuring that the medical specialists visit the patient, implementing nurse coordinators and considering patient wishes and co-morbidities when formulating a treatment plan. IMPLEMENTATION: A mandate from the board (Top-down), ensured cooperation between different medical departments and a change in resource allocation (i.e. medical staff); a horizontal clinic across a vertical departmental structure. Brainstorm sessions between the departments led by two physicians who were going to work at the FTC (Bottom-up), assured a swift implementation of the FTC. EVALUATION: Since implementation in 2009, patient influx has tripled. Waiting time for an appointment and start of treatment was reduced from 2-4 weeks to 6 working days and from 12-14 weeks to 17 working days, respectively. This was achieved by re-allocating recourses, but without increasing existing resources. LESSONS LEARNED: The combination of a top-down and bottom-up strategy ensured participation from all involved departments, a strong foundation and a shared vision on patient centered care. The FTC facilitates sharing information between different medical specialists through both proximity and a shared electronic patient record. The implementation of the FTC comprises a change in organization, but not a change in structure.

Adenoma detection with Endocuff colonoscopy versus conventional colonoscopy: a multicentre randomised controlled trial.

BACKGROUND AND AIMS: Colonoscopy is the current reference standard for the detection of colorectal neoplasia, but nevertheless adenomas remain undetected. The Endocuff, an endoscopic cap with plastic projections, may improve colonic visualisation and adenoma detection. The aim of this study was to compare the mean number of adenomas per patient (MAP) and the adenoma detection rate (ADR) between Endocuff-assisted colonoscopy (EAC) and conventional colonoscopy (CC). METHODS: We performed a multicentre, randomised controlled trial in five hospitals and included fecal immonochemical test (FIT)-positive screening participants as well as symptomatic patients (>45 years). Consenting patients were randomised 1:1 to EAC or CC. All colonoscopies were performed by experienced colonoscopists (≥500 colonoscopies) who were trained in EAC. All colonoscopy quality indicators were prospectively recorded. FINDINGS: Of the 1063 included patients (52% male, median age 65 years), 530 were allocated to EAC and 533 to CC. More adenomas were detected with EAC, 722 vs 621, but the gain in MAP was not significant: on average 1.36 per patient in the EAC group versus 1.17 in the CC group (p=0.08). In a per-protocol analysis, the gain was 1.44 vs 1.19 (p=0.02), respectively. In the EAC group, 275 patients (52%) had one or more adenomas detected versus 278 in the CC group (52%; p=0.92). For advanced adenomas these numbers were 109 (21%) vs 117 (22%). The adjusted caecal intubation rate was lower with EAC (94% vs 99%; p<0.001), however when allowing crossover from EAC to CC, they were similar in both groups (98% vs 99%; p value=0.25). INTERPRETATION: Though more adenomas are detected with EAC, the routine use of Endocuff does not translate in a higher number of patients with one or more adenomas detected. Whether increased detection ultimately results in a lower rate of interval carcinomas is not yet known. TRIAL REGISTRATION NUMBER: http://www.trialregister.nl Dutch Trial Register: NTR3962.

Waiting time at a fast-track diagnostic clinic.

Purpose - Guidelines stating maximum waiting times fail to take cancer patients' expectations into account. Therefore, the purpose of this paper is to assess patients' expectations and experiences with their waiting time at a fast-track clinic. Design/methodology/approach - Patients were selected using a purposeful sampling strategy and were interviewed four times: before the visit; one day after; two weeks after the visit; and one week after starting treatment. Interviews were audiotaped and independently coded by two researchers. Findings - All patients (n=9) preferred a short waiting time before the first visit; they feared that their disease would spread and believed that cancer warrants priority treatment. Six patients experienced the waiting time as short, one had no expectations and two felt they waited longer than expected; three patients changed this evaluation during the study. Six patients received treatment - four preferred to wait before treatment and two wanted to start treatment immediately. Reasons to wait included putting one's affairs in order, or needing to adjust to the diagnosis. Practical implications - Cancer patients prefer a short waiting time before the first visit but have different expectations and needs regarding waiting time before treatment. Ideally, their expectations are managed by their treating physician to match waiting time reality. Originality/value - This is the first study to assess cancer patients' waiting time experiences and how these experiences change over time. This study paves the way for establishing a framework to better assess patient satisfaction with oncology care waiting time. An important aspect, is managing patients' expectations.

Metal or plastic stents for preoperative biliary drainage in resectable pancreatic cancer.

INTRODUCTION: In pancreatic cancer, preoperative biliary drainage (PBD) increases complications compared with surgery without PBD, demonstrated by a recent randomised controlled trial (RCT). This outcome might be related to the plastic endoprosthesis used. Metal stents may reduce the PBD-related complications risk. METHODS: A prospective multicentre cohort study was performed including patients with obstructive jaundice due to pancreatic cancer, scheduled to undergo PBD before surgery. This cohort was added to the earlier RCT (ISRCTN31939699). The RCT protocol was adhered to, except PBD was performed with a fully covered self-expandable metal stent (FCSEMS). This FCSEMS cohort was compared with the RCT's plastic stent cohort. PBD-related complications were the primary outcome. Three-group comparison of overall complications including early surgery patients was performed. RESULTS: 53 patients underwent PBD with FCSEMS compared with 102 patients treated with plastic stents. Patients' characteristics did not differ. PBD-related complication rates were 24% in the FCSEMS group vs 46% in the plastic stent group (relative risk of plastic stent use 1.9, 95% CI 1.1 to 3.2, p=0.011). Stent-related complications (occlusion and exchange) were 6% vs 31%. Surgical complications did not differ, 40% vs 47%. Overall complication rates for the FCSEMS, plastic stent and early surgery groups were 51% vs 74% vs 39%. CONCLUSIONS: For PBD in pancreatic cancer, FCSEMS yield a better outcome compared with plastic stents. Although early surgery without PBD remains the treatment of choice, FCSEMS should be preferred over plastic stents whenever PBD is indicated. TRIAL REGISTRATION NUMBER: Dutch Trial Registry (NTR3142).

A multicentre comparative prospective blinded analysis of EUS and MRI for screening of pancreatic cancer in high-risk individuals.

OBJECTIVE: Endoscopic ultrasonography (EUS) and MRI are promising tests to detect precursors and early-stage pancreatic ductal adenocarcinoma (PDAC) in high-risk individuals (HRIs). It is unclear which screening technique is to be preferred. We aimed to compare the efficacy of EUS and MRI in their ability to detect clinically relevant lesions in HRI. DESIGN: Multicentre prospective study. The results of 139 asymptomatic HRI (>10-fold increased risk) undergoing first-time screening by EUS and MRI are described. Clinically relevant lesions were defined as solid lesions, main duct intraductal papillary mucinous neoplasms and cysts ≥10 mm. Results were compared in a blinded, independent fashion. RESULTS: Two solid lesions (mean size 9 mm) and nine cysts ≥10 mm (mean size 17 mm) were detected in nine HRI (6%). Both solid lesions were detected by EUS only and proved to be a stage I PDAC and a multifocal pancreatic intraepithelial neoplasia 2. Of the nine cysts ≥10 mm, six were detected by both imaging techniques and three were detected by MRI only. The agreement between EUS and MRI for the detection of clinically relevant lesions was 55%. Of these clinically relevant lesions detected by both techniques, there was a good agreement for location and size. CONCLUSIONS: EUS and/or MRI detected clinically relevant pancreatic lesions in 6% of HRI. Both imaging techniques were complementary rather than interchangeable: contrary to EUS, MRI was found to be very sensitive for the detection of cystic lesions of any size; MRI, however, might have some important limitations with regard to the timely detection of solid lesions.

Value of EUS in Determining Curative Resectability in Reference to CT and FDG-PET: The Optimal Sequence in Preoperative Staging of Esophageal Cancer?

BACKGROUND: The separate value of endoscopic ultrasonography (EUS), multidetector computed tomography (CT), and 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) in the optimal sequence in staging esophageal cancer has not been investigated adequately. METHODS: The staging records of 216 consecutive operable patients with esophageal cancer were reviewed blindly. Different staging strategies were analyzed, and the likelihood ratio (LR) of each module was calculated conditionally on individual patient characteristics. A logistic regression approach was used to determine the most favorable staging strategy. RESULTS: Initial EUS results were not significantly related to the LRs of initial CT and FDG-PET results. The positive LR (LR+) of EUS-fine-needle aspiration (FNA) was 4, irrespective of CT and FDG-PET outcomes. The LR+ of FDG-PET varied from 13 (negative CT) to 6 (positive CT). The LR+ of CT ranged from 3-4 (negative FDG-PET) to 2-3 (positive FDG-PET). Age, histology, and tumor length had no significant impact on the LRs of the three diagnostic tests. CONCLUSIONS: This study argues in favor of PET/CT rather than EUS as a predictor of curative resectability in esophageal cancer. EUS does not correspond with either CT or FDG-PET. LRs of FDG-PET were substantially different between subgroups of negative and positive CT results and vice versa.

Participation, yield, and interval carcinomas in three rounds of biennial FIT-based colorectal cancer screening.

BACKGROUND: The effectiveness of colorectal cancer screening programs based on the fecal immunochemical test (FIT) is influenced by program adherence during consecutive screening rounds. We aimed to evaluate the participation rate, yield, and interval cancers in a third round of biennial CRC screening using FIT and to compare those with the first and the second screening round. METHODS: A total of 3566 average-risk individuals aged 50-75 years were invited to participate in a third round of biennial FIT-based CRC screening. All FIT positives were recommended to undergo colonoscopy. We merged our data with the national cancer registry in the Netherlands to identify all non-screen-detected cancers in our cohort. RESULTS: Of the invitees, 2142 (60%) returned the FIT in this third screening round, compared to 56% in the second round and 57% in the first round. Overall, 153 of the third-round participants (7.1%) had a positive FIT result, versus 7.9% in the second round and 8.1% in the first round (P=0.05). Of all FIT positives, 123 (80%) underwent colonoscopy. Within this group, 33 persons had advanced neoplasia. The predictive value of FIT positivity for advanced neoplasia was 27% (33/123), compared to 42% in the second round and 54% in the first round - a significant decline (P<0.01). CONCLUSION: In an FIT-based screening program, participation rates remained stable over consecutive biennial screening rounds, while the FIT positivity rate and positive predictive value for advanced neoplasia gradually declined. Cancers in non-participants are significantly more advanced in staging than cancers in participants in the first round of screening.

Long-term results of palliative stent placement for acute malignant colonic obstruction.

BACKGROUND: Endoscopic placement of self-expanding-metal-stents (SEMS) is widely performed as palliative treatment for acute malignant colonic obstruction. There is ongoing debate regarding risks and benefits associated with SEMS placement. This study aimed to evaluate long-term outcomes of palliative SEMS placement in patients presenting with acute malignant colonic obstruction. METHODS: A prospectively collected patient cohort (2005-2013) from a general teaching hospital was used. In this hospital, all consecutive patients presenting with acute malignant large bowel obstruction are treated with endoscopic SEMS placement. Only colon cancer patients who underwent palliative SEMS placement were selected. RESULTS: In total, 48 patients were included. The technical and short-term clinical success rates were 91 % (44/48) and 85 % (36/48), respectively. SEMS-related mortality occurred in 6/48 patients (13 %) (early n = 4, late n = 2) and was caused by SEMS-related perforation in all cases. The SEMS-related morbidity rate was 38 % (18/48) (early n = 7, late n = 11). Endoscopic re-intervention was performed 14 times and 13 patients eventually underwent surgical treatment during follow-up. The stoma-formation rate was 15 % (7/48). Long-term clinical success was 48 % (23/48). The estimated stent patency rate (95 % confidence interval) was 69 % (52-79) at 1 month, 54 % (37-66) at 6 months and 50 % (33-62) at 12 months. CONCLUSION: Palliative SEMS placement provides rapid relief of obstruction and avoids a stoma in most patients with acute colonic obstruction caused by incurable or inoperable colon cancer. However, these benefits should be weighed against mortality and morbidity related to SEMS placement.

Endoscopic mucosal resection of large rectal adenomas in the era of centralization: Results of a multicenter collaboration.

BACKGROUND AND OBJECTIVE: Endoscopic mucosal resection (EMR) of large rectal adenomas is largely being centralized. We assessed the safety and effectiveness of EMR in the rectum in a collaboration of 15 Dutch hospitals. METHODS: Prospective, observational study of patients with rectal adenomas >3 cm, resected by piecemeal EMR. Endoscopic treatment of adenoma remnants at 3 months was considered part of the intervention strategy. Outcomes included recurrence after 6, 12 and 24 months and morbidity. RESULTS: Sixty-four patients (50% male, age 69 ± 11, 96% ASA 1/2) presented with 65 adenomas (diameter 46 ± 17 mm, distance ab ano 4.5 cm (IQR 1-8), 6% recurrent lesion). Sixty-two procedures (97%) were technically successful. Histopathology revealed invasive carcinoma in three patients (5%), who were excluded from effectiveness analyses. At 3 months' follow-up, 10 patients showed adenoma remnants. Recurrence was diagnosed in 16 patients during follow-up (recurrence rate 25%). Fifteen of 64 patients (23%) experienced 17 postprocedural complications. CONCLUSION: In a multicenter collaboration, EMR was feasible in 97% of patients. Recurrence and postprocedural morbidity rates were 25% and 23%. Our results demonstrate the outcomes of EMR in the absence of tertiary referral centers.

Oncological outcome of malignant colonic obstruction in the Dutch Stent-In 2 trial.

BACKGROUND: The Stent-In 2 trial randomized patients with malignant colonic obstruction to emergency surgery or stent placement as a bridge to elective surgery. The aim of this study was to compare the oncological outcomes. METHODS: Disease recurrence, and disease-free, disease-specific and overall survival were evaluated, including a subgroup analysis of patients with a stent- or guidewire-related perforation. RESULTS: Of 98 patients included in the original Stent-In 2 trial, patients with benign (16) or incurable (23) disease were excluded from this study, along with a patient who had withdrawn from the trial. Of the remaining 58 patients, 32 were randomized to emergency surgery (31 resection, 1 stoma only) and 26 to stenting. Unsuccessful stenting required emergency surgery in six patients owing to wire or stent perforation. Locoregional or distant disease recurrence developed in nine of 32 patients in the emergency surgery group and 13 of 26 in the stent group. Disease-free survival was worse in the subgroup with stent- or guidewire-related perforation. Five of six patients in this subgroup developed a recurrence, compared with nine of 32 in the emergency surgery group and eight of 20 who had unperforated stenting. CONCLUSION: Stent placement for malignant colonic obstruction was associated with a risk of recurrence in this trial, but the numbers are small. There is not enough evidence to refute the approach strongly. REGISTRATION NUMBER: ISRCTN46462267 ( http://www.controlled-trials.com).

Is "really conscious" sedation with solely an opioid an alternative to every day used sedation regimes for colonoscopies in a teaching hospital? Midazolam/fentanyl, propofol/alfentanil, or alfentanil only for colonoscopy: a randomized trial.

BACKGROUND: We investigated the satisfaction of patients and endoscopists and concurrently safety aspects of an "alfentanil only" and two clinically routinely used sedation regimes in patients undergoing colonoscopy in a teaching hospital. METHODS: One hundred and eighty patients were prospectively randomized in three groups: M (midazolam/fentanyl), A (alfentanil), and P (propofol/alfentanil); M and A were administered by an endoscopy nurse, P by an anesthesia nurse. Interventions, heart rate, saturation, electrocardiogram, noninvasive blood pressure, and expiratory CO2 were monitored using video assistance. After endoscopy, patients and gastroenterologists completed questionnaires about satisfaction. RESULTS: A high level of satisfaction was found in all groups, with patients in group P being more satisfied with their sedation experience (median 1.75, p < 0.001). Gastroenterologist satisfaction varied not significantly between the three alternatives. Patients in group A felt less drowsy, could communicate more rapidly than patients in both other groups, and met discharge criteria immediately after the end of the procedure. Respiratory events associated with sedation were observed in 43% patients in group M, 47% in group P, but only 13% in group A (p < 0.001). CONCLUSIONS: These results suggest that alfentanil could be an alternative for sedation in colonoscopy even in the setting of a teaching hospital. It results in satisfied patients easily taking up information, and recovering rapidly. Although one might expect to observe more respiratory depression with an "opioid only" sedation technique without involvement of anesthesia partners, respiratory events were less frequent than when other methods were used.