Effectiveness of Mindfulness-Based Cognitive Therapy in reducing psychological distress and improving sleep in patients with Inflammatory Bowel Disease: study protocol for a multicentre randomised controlled trial (MindIBD).

BACKGROUND: Many patients with Inflammatory Bowel Diseases (IBD) suffer from psychological distress, fatigue and sleep disturbances, which are associated with reduced quality of life (QoL) and increased societal costs. Only limited psychosocial treatment options are available. As Mindfulness-Based Cognitive Therapy (MBCT) has demonstrated to improve psychological distress, QoL and sleep in other populations, MBCT might also be effective in patients with IBD. METHODS: The MindIBD study is a prospective, multicentre, randomised controlled trial comparing MBCT plus Treatment As Usual (TAU) versus TAU alone in a targeted number of 136 IBD patients in remission, aged 16 years and older with at least mild psychological distress (Hospital Anxiety and Depression Scale (HADS) total score ≥ 11). Primary outcome is reduction of psychological distress post-intervention, measured by the HADS. In addition, the effect of MBCT on sleep quality (including actigraphy and electroencephalography recordings), fatigue, disease activity, perceived disease control, QoL and positive mental health will be examined. Assessments will be conducted at baseline and at 3, 6, 9 and 12 months follow-up. Cost-effectiveness will be determined and a process evaluation will be conducted. DISCUSSION: This study will provide valuable insight into the clinical effect of MBCT on psychological distress, sleep quality, fatigue and QoL in IBD patients and into the cost-effectiveness. If effective, MBCT can be a valuable addition to the available psychosocial interventions for patients with IBD. Moreover, findings from this study may also be applicable in patients with other chronic conditions. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04646785, registered on 30/11/2020.

Accuracy of upper endoscopies with random biopsies to identify patients with gastric premalignant lesions who can safely be exempt from surveillance.

INTRODUCTION: Guidelines recommend endoscopy with biopsies to stratify patients with gastric premalignant lesions (GPL) to high and low progression risk. High-risk patients are recommended to undergo surveillance. We aimed to assess the accuracy of guideline recommendations to identify low-risk patients, who can safely be discharged from surveillance. METHODS: This study includes patients with GPL. Patients underwent at least two endoscopies with an interval of 1-6 years. Patients were defined 'low risk' if they fulfilled requirements for discharge, and 'high risk' if they fulfilled requirements for surveillance, according to European guidelines (MAPS-2012, updated MAPS-2019, BSG). Patients defined 'low risk' with progression of disease during follow-up (FU) were considered 'misclassified' as low risk. RESULTS: 334 patients (median age 60 years IQR11; 48.7% male) were included and followed for a median of 48 months. At baseline, 181/334 (54%) patients were defined low risk. Of these, 32.6% were 'misclassified', showing progression of disease during FU. If MAPS-2019 were followed, 169/334 (51%) patients were defined low risk, of which 32.5% were 'misclassified'. If BSG were followed, 174/334 (51%) patients were defined low risk, of which 32.2% were 'misclassified'. Seven patients developed gastric cancer (GC) or dysplasia, four patients were 'misclassified' based on MAPS-2012 and three on MAPS-2019 and BSG. By performing one additional endoscopy 72.9% (95% CI 62.4-83.3) of high-risk patients and all patients who developed GC or dysplasia were identified. CONCLUSION: One-third of patients that would have been discharged from GC surveillance, appeared to be 'misclassified' as low risk. One additional endoscopy will reduce this risk by 70%.

Low value of second-look endoscopy for detecting residual colorectal cancer after endoscopic removal.

BACKGROUND AND AIMS: Endoscopic resection is often feasible for submucosal invasive colorectal cancers (T1 CRCs) and usually judged as complete. If histology casts doubt on the radicality of resection margins, adjuvant surgical resection is advised, although residual intramural cancer is found in only 5% to 15% of patients. We assessed the sensitivity of biopsy specimens from the resection area for residual intramural cancer as a potential tool to estimate the preoperative risk of residual intramural cancer in patients without risk factors for lymph node metastasis (LNM). METHODS: In this multicenter prospective cohort study, patients with complete endoscopic resection of T1 CRC, scheduled for adjuvant resection due to pathologically unclear resection margins, but absent risk factors for LNM, were asked to consent to second-look endoscopy with biopsies. The results were compared with the pathology results of the surgical resection specimen (criterion standard). RESULTS: One hundred three patients were included. In total, 85% of resected lesions were unexpectedly malignant, and 45% were removed using a piecemeal resection technique. Sixty-four adjuvant surgical resections and 39 local full-thickness resections were performed. Residual intramural cancer was found in 7 patients (6.8%). Two of these patients had cancer in second-look biopsy specimens, resulting in a sensitivity of 28% (95% confidence interval, <58%). The preoperative risk of residual intramural cancer in the case of negative biopsy specimens was not significantly reduced (P = .61). CONCLUSIONS: The sensitivity of second-look endoscopy with biopsies for residual intramural cancer after endoscopic resection of CRC is low. Therefore, it should not be used in the decision whether or not to perform adjuvant resection. (Clinical trial registration number: NCT02328664.).

Surveillance of premalignant gastric lesions: a multicentre prospective cohort study from low incidence regions.

OBJECTIVE: International guidelines recommend endoscopic surveillance of premalignant gastric lesions. However, the diagnostic yield and preventive effect require further study. We therefore aimed to assess the incidence of neoplastic progression and to assess the ability of various tests to identify patients most at risk for progression. DESIGN: Patients from the Netherlands and Norway with a previous diagnosis of atrophic gastritis (AG), intestinal metaplasia (IM) or dysplasia were offered endoscopic surveillance. All histological specimens were assessed according to the updated Sydney classification and the operative link on gastric intestinal metaplasia (OLGIM) system. In addition, we measured serum pepsinogens (PG) and gastrin-17. RESULTS: 279 (mean age 57.9 years, SD 11.4, male/female 137/142) patients were included and underwent at least one surveillance endoscopy during follow-up. The mean follow-up time was 57 months (SD 36). Four subjects (1.4%) were diagnosed with high-grade adenoma/dysplasia or invasive neoplasia (ie, gastric cancer) during follow-up. Two of these patients were successfully treated with endoscopic submucosal dissection, while the other two underwent a total gastrectomy. Compared with patients with extended AG/IM (PGI/II≤3 and/or OGLIM stage III-IV), patients with limited AG/IM (PG I/II>3 and OLGIM stage 0-II) did not develop high-grade adenoma/dysplasia or invasive neoplasia during follow-up (p=0.02). CONCLUSION: In a low gastric cancer incidence area, a surveillance programme can detect gastric cancer at an early curable stage with an overall risk of neoplastic progression of 0.3% per year. Use of serological markers in endoscopic surveillance programmes may improve risk stratification.

Rising incidence and prevalence of primary biliary cirrhosis: a large population-based study.

BACKGROUND & AIMS: Large population-based studies are much needed to accurately establish the epidemiology of primary biliary cirrhosis (PBC). We aimed to collect all PBC patients in a geographically defined area to evaluate the epidemiology of PBC and examine the possible association of PBC with smoking, age at menarche, age at first pregnancy and number of pregnancies. METHODS: All PBC patients between 2000 and 2008 were identified in a geographically defined area of the Netherlands, comprising 50% of the Dutch population. Four independent hospital databases were searched in 44 hospitals. Medical records were reviewed on site verifying diagnosis and for collection of clinical data. Age- and gender matched controls were recruited from the outpatient clinics of four participating hospitals. Patients and controls were asked to fill out a questionnaire regarding family history, previous and current smoking behaviour and fertility status. RESULTS: Nine hundred and ninety-two PBC patients fulfilled all inclusion criteria, resulting in a mean incidence of 1.1 per 100 000; 0.3 in men and 1.9 in women. On January 1st 2008 the point prevalence was 13.2 per 100 000 inhabitants. Incidence and prevalence rates were increasing over time (P < 0.001). No geographical differences in disease distribution were observed. Smoking behaviour, age at menarche, age at first pregnancy, gravidity and number of children were not significantly different between cases and controls. CONCLUSION: Incidence and prevalence rates of PBC are increasing over time. PBC was not found to be associated with smoking, age at menarche, age at first pregnancy or number of pregnancies.

Increased cancer risk in a large population-based cohort of patients with primary biliary cirrhosis: follow-up for up to 36 years.

BACKGROUND AND AIMS: The natural history of primary biliary cirrhosis (PBC) has so far mainly been studied in tertiary referral centres. The aim of the present investigation was to describe the natural history of PBC in a large population-based cohort in order to identify risk factors for development of malignancies and disease progression. METHODS: Four independent hospital databases were searched in 44 hospitals in a geographically defined area, after which all medical records were evaluated on site. In addition, PBC registries in the three liver transplant centers were checked for missed referrals from the area of interest. RESULTS: In total, 992 cases fulfilled the inclusion criteria. The median follow-up was 73 months (range 0-434). Mortality was similar to the age- and gender matched population (SMR 1.1; 95 % CI 0.9-1.4). Male gender, smoking, and elevated bilirubin, decreased albumin, and elevated AST at time of diagnosis, were associated with an increased risk for the combined end point PBC-related death or liver transplantation. In total, 133 (13 %) patients developed one or more malignancies (SIR 1.5; 95 % CI 1.1-1.9). There was a ninefold increased risk of developing hepatobiliary malignancies (SIR 9.4; 95 % CI 3.04-21.8), a fivefold increased risk of developing urinary bladder cancer (SIR 5.0; 95 % CI 1.6-11.6), and a 1.8-fold increased risk of developing breast cancer (SIR 1.8; 95 % CI 1.08-2.81). CONCLUSION: PBC is associated with an increased risk of hepatobiliary, bladder and breast cancer. Still, survival-under treatment with ursodeoxycholic acid (UDCA)-was comparable to the general population in this population-based study.

[Severe vitamin D deficiency and hypocalcaemia after bariatric surgery]. / Ernstige vitamine D-deficiëntie en hypocalciëmie na bariatrische chirurgie.

A 60-year-old man was referred to the accident and emergency department because of muscle cramps and retrosternal pain. Laboratory tests revealed severe vitamin D deficiency and hypocalcaemia. The patient had undergone bariatric surgery several years previously. Disturbances in fat-soluble vitamins and in minerals are a frequent complication after bariatric procedures. Recognition and treatment of these disorders is very important.

Open-access upper gastrointestinal endoscopy a decade after the introduction of proton pump inhibitors and helicobacter pylori eradication: a shift in endoscopic findings.

BACKGROUND/AIM: Over the past 15 years, there were considerable changes in factors associated with the development and treatment of upper gastrointestinal symptoms, of which the introduction of proton pump inhibitors and Helicobacter pylori eradication in guidelines for treatment of patients with dyspepsia are the most prominent: findings at open-access upper gastrointestinal endoscopy have not been evaluated properly ever since. This study aims to compare the current prevalence of upper gastrointestinal endoscopic findings to the prevalence 15 years ago. METHODS: Data about endoscopic findings of consecutive patients for the first time referred for open-access upper gastrointestinal endoscopy between January 2002 and December 2004 was collected from medical files. The prevalence of each specific finding was compared with data described in three historical populations about 15 years ago. RESULTS: The current and historical study population consisted of 1,286 and 3,062 subjects, respectively. The prevalence of peptic ulcer disease and duodenitis significantly decreased by 12.6% (95% CI: 14.5-10.7) and 2.9% (95% CI: 4.5-1.3), respectively. On the other hand, the prevalence of reflux esophagitis and Barrett's esophagus both significantly increased by 6.9% (95% CI: 4.2-9.6) and 2.1% (95% CI: 0.8-4.4), respectively. CONCLUSIONS: Compared to 15 years ago, the prevalence of specific findings at open-access upper gastrointestinal endoscopy has changed considerably.

Alexithymia is associated with gastrointestinal symptoms, but does not predict endoscopy outcome in patients with gastrointestinal symptoms.

BACKGROUND: Alexithymia, where a person has difficulty in distinguishing between emotions and bodily sensations, is considered to be a character trait and a vulnerability factor for various psychosomatic disorders. Assessing alexithymia in patients with gastrointestinal (GI) symptoms before endoscopy might therefore be useful in selecting patients who are more prone to functional GI disorders. GOAL: To determine whether alexithymia might be a useful factor in predicting GI endoscopy outcomes. STUDY: Patients referred for endoscopy between February 2002 and February 2004 were enrolled. They were asked to report alexithymia on the Toronto Alexithymia Scale-20 2 weeks before endoscopy. Information about endoscopic diagnoses was obtained from medical files. RESULTS: A total of 1141 subjects was included (49% male), of whom 245 (21%) reported alexithymia. There was no difference in mean+/-SD alexithymia scores between patients with (51+/-12) and without (50+/-12) an endoscopic organic abnormality at GI endoscopy. When divided into subgroups, according to the most prominent finding at either upper or lower GI endoscopy, there was no association with alexithymia. Patients with alexithymia reported a worse sensation of GI symptoms during the last weeks before enrollment in the study (mean+/-SD symptom severity score: 42+/-34 vs. 34+/-30, respectively; P<0.01). CONCLUSIONS: Alexithymia is not associated with endoscopic findings, and has therefore no additive value in predicting endoscopy outcomes. Patients with alexithymia more often present with a higher number and more severe GI symptoms.

Predominant symptom behavior in patients with persistent dyspepsia during treatment.

BACKGROUND: Grouping of patients based on a predominant dyspeptic symptom is frequently employed in management strategies for dyspepsia. Such subdivision, however, suggests that dyspeptic symptom patterns are constant over time. OBJECTIVE: To investigate the behavior of symptoms over time and to study the effects of diagnostic procedures and treatment on the pattern and severity of dyspeptic symptoms. METHODS: Patients with persistent dyspeptic symptoms completed a validated questionnaire at regular time intervals as part of a clinical trial in primary care. Based on predominant symptoms, patients were classified into ulcer-like dyspepsia, reflux-like dyspepsia, dysmotility-like dyspepsia, and unspecific dyspepsia according to the Rome II criteria. RESULTS: Questionnaires were returned at baseline, 1, 3, and 6 months by 185, 172, 169, and 170 patients, respectively. At baseline, 35% of patients reported predominantly reflux-like dyspepsia, 34% had ulcer-like dyspepsia, 16% had dysmotility-like dyspepsia, and in 15% symptoms were not specific. During the 6-month follow-up period, only 35% of patients kept the same predominant symptom. Symptom (in)stability was not dependent on diagnostic procedures or on therapy with proton pump inhibitors, H2-receptor antagonists, prokinetics, or antacids. CONCLUSION: In the majority of dyspeptic patients, symptoms change continuously as time goes on. Symptom instability is not influenced by diagnostic procedures or therapy. Thus, there is little sense in symptom-based management of dyspepsia in primary care.