Efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn's disease: a phase 3, multicentre, randomised, double-blind, placebo-controlled and active-controlled, treat-through study.

Background: Mirikizumab, a humanised monoclonal antibody that inhibits IL-23p19, is effective in moderate-to-severe ulcerative colitis. We aimed to evaluate the efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn's disease.

Methods: VIVID-1 was a global phase 3, randomised, double-blind, double-dummy, placebo-controlled and active-controlled, treat-through study.

Burden of Bowel Urgency in Patients With Ulcerative Colitis and Crohn's Disease: A Real-World Global Study.

Background: Bowel urgency is a highly disruptive and bothersome symptom experienced by patients with inflammatory bowel diseases (IBD), (ulcerative colitis [UC], and Crohn's disease [CD]). However, the burden of bowel urgency among patients with varying experiences in targeted treatment has not been consistently assessed. This real-world study explored the clinical and health-related quality of life burden of bowel urgency among patients with IBD with differing treatment experiences.

EORTC 1409 GITCG/ESSO 01 - A prospective colorectal liver metastasis database for borderline or initially unresectable diseases (CLIMB): Lessons learnt from real life. From paradigm to unmet need.

Aim: Multidisciplinary management of metastatic colorectal liver metastases (CRLM) is still challenging. To assess postoperative complications in initially unresectable or borderline resectable CRLM, the prospective EORTC-1409 ESSO 01-CLIMB trial capturing 'real-life data' of European centres specialized in liver surgery was initiated.

Material And Methods: A total of 219 patients were registered between May 2015 and January 2019 from 15 centres in nine countries.

Declining Enrolment and Other Challenges in IBD Clinical Trials: Causes and Potential Solutions.

Background: Rates of enrolment in clinical trials in inflammatory bowel disease [IBD] have decreased dramatically in recent years. This has led to delays, increased costs and failures to develop novel treatments.

Aims: The aim of this work is to describe the current bottlenecks of IBD clinical trial enrolment and propose solutions.

The Clinical Benefit of Percutaneous Transhepatic Biliary Drainage for Malignant Biliary Tract Obstruction.

Percutaneous transhepatic biliary drainage (PTBD) is a decompression procedure for malignant proximal biliary obstruction. In this research, over a six-year period, 89 patients underwent PTBD procedure for jaundice caused by malignant disease to restart chemotherapy or for palliative intent. Clinical outcomes after PTBD procedure in the two groups of patients, according to the adequate bilirubin decline (ABD) needed for subsequent chemotherapy, are presented in this paper.

Corticosteroids and Mesalamine Versus Corticosteroids for Acute Severe Ulcerative Colitis: A Randomized Controlled Trial.

Background & Aims: Corticosteroids are the mainstay of treatment for hospitalized patients with acute severe ulcerative colitis (ASUC). However, whether the addition/continuation of mesalamine with corticosteroids during hospitalization is superior to corticosteroids alone is unknown.

Methods: This was a randomized controlled, investigator-blinded, clinical trial conducted in 10 centers in 7 countries.

Prospective Non-Randomized Study of Intraoperative Assessment of Surgical Resection Margin of Colo-Rectal Liver Metastases.

More than 50% of patients with colorectal cancer (CRC) develop liver metastases during the natural course of disease. Surgical resection is currently the most potentially curative method in the treatment of colorectal liver metastases (CRLM). The goal of surgery is to achieve a negative resection margin (RM) of at least 1 mm, which provides the best prognosis for patients.

Building a collaboration to improve surgical research through EORTC/ESSO 1409-CLIMB study: A prospective liver metastasis database with an integrated quality assurance program.

The challenges of conducting surgical oncology trials have resulted to low quantity and poor quality research [1,2]. Considering the definitive role of surgery to offer cure, immediate response to improve surgical research is needed [3]. The European Organization for Research and Treatment of Cancer (EORTC) and the European Society of Surgical Oncology (ESSO) share the vision to achieve excellent surgical research and care for cancer patients.

Both the intratumoral immune and microbial microenvironment are linked to recurrence in human colon cancer: results from a prospective, multicenter nodal ultrastaging trial.

Colon cancer (CC) is the third most common cancer diagnosed in the United States and the incidence has been rising among young adults. We and others have shown a relationship between the immune infiltrate and prognosis, with improved disease-free survival (DFS) being associated with a higher expression of CD8 T cells. We hypothesized that a microbial signature might be associated with intratumoral immune cells as well as DFS.

The Negative Impact of Body Mass Index on the Tumor Microenvironment in Colon Cancer: Results of a Prospective Trial.

Background: The association between tumor mismatch repair status and obesity in colon cancer is not well understood. The authors of this study hypothesized that mismatch repair deficiency in colon cancer may be associated with a lower Body Mass Index (BMI) and improved patient outcome due to an enhanced tumor immune microenvironment.

Methods: For this study, 70 patients were randomly selected from a prospective trial evaluating nodal ultrastaging for colon cancer.

Combination of corticosteroids and 5-aminosalicylates or corticosteroids alone for patients with moderate-severe active ulcerative colitis: A global survey of physicians' practice.

Aim: To examine treatment decisions of gastroenterologists regarding the choice of prescribing 5-aminosalycilates (5ASA) with corticosteroids (CS) versus corticosteroids alone for patients with active ulcerative colitis (UC).

Methods: A cross-sectional questionnaire exploring physicians' attitude toward 5ASA + CS combination therapy CS alone was developed and validated. The questionnaire was distributed to gastroenterology experts in twelve countries in five continents.

Anti-TNF Treatment for Extraintestinal Manifestations of Inflammatory Bowel Disease in the Swiss IBD Cohort Study.

Background: Extraintestinal manifestations (EIMs) in patients with inflammatory bowel disease (IBD) are frequently observed. Little is known about the efficacy of anti-tumor necrosis factor (TNF) in EIM management. We assessed the effect of 3 anti-TNF agents (infliximab, adalimumab, and certolizumab pegol) on EIM evolution.

Sex-Specific Differences in Colon Cancer when Quality Measures Are Adhered to: Results from International, Prospective, Multicenter Clinical Trials.

Background: There is no consensus on the relationship between patient sex and the location, stage, and oncologic outcome of colon cancer (CC). We hypothesized that there is a sex-specific difference in the biology and management of CC.

Study Design: Our cohort was drawn from a database of patients enrolled in international trials of nodal ultrastaging for nonmetastatic CC.

Case Report: Acute Flair of Ulcerative Colitis during Pregnancy Is Still a Major Problem.

Although severe flare of ulcerative colitis (UC) is uncommon, it significantly increases the risk of preterm delivery, low birth weight and other adverse fetal outcomes. It is critical to optimize aggressive medical treatment with both mother and fetal health. Here, we present a case of a 30-year-old woman with a severe flare of UC at the 16th gestational week.

Development of psoriasis in IBD patients under TNF-antagonist therapy is associated neither with anti-TNF-antagonist antibodies nor trough levels.

Background: The cause of anti-TNF-induced psoriasis is still unknown.

Objective: We aimed to evaluate if the appearance of psoriasis under anti-TNF therapy is associated with anti-TNF antibody levels and TNF-antagonist trough levels.

Methods: In this case-control study we identified 23 patients (21 with Crohn's disease [CD], two with ulcerative colitis [UC]) who developed psoriasis under infliximab (IFX, n = 20), adalimumab (ADA, n = 2), and certolizumab pegol (CZP, n= 1) and compared them regarding the anti-TNF-antagonist antibody levels with 85 IBD patients (72 with CD, 13 with UC) on anti-TNF therapy without psoriasis.

Prospective randomized controlled trial comparing standard analgesia with combined intra-operative cystic plate and port-site local anesthesia for post-operative pain management in elective laparoscopic cholecystectomy.

Background: Various mechanisms, including somatic and visceral nociceptive stimulation, have been suggested as a cause for pain after laparoscopic cholecystectomy (LC). We therefore conducted a prospective randomized controlled trial (PRCT) to evaluate whether somatovisceral pain blockade reduces pain after LC.

Hypothesis: Analgesic efficacy of multimodal analgesia is superior to standard analgesia for patients undergoing elective LC for symptomatic cholelithiasis.

Postoperative complications and overall survival after pancreaticoduodenectomy for pancreatic ductal adenocarcinoma.

Introduction: Pancreaticoduodenectomy (PD) performed for pancreatic ductal adenocarcinoma (PDA) has a postoperative morbidity of 40-50%. In this study, we analyzed the impact of high grade complications after PD for PDA on overall survival.

Methods: A total of 596 patients that underwent PD for PDA between 2001 and 2009 were identified from a prospective database.

Prognostic Effect of Ultra-Staging Node-Negative Colon Cancer Without Adjuvant Chemotherapy: A Prospective National Cancer Institute-Sponsored Clinical Trial.

Background: We recently reported, in a prospective randomized trial, that ultra-staging of patients with colon cancer is associated with significantly improved disease-free survival (DFS) compared with conventional staging. That trial did not control for lymph node (LN) number or adjuvant chemotherapy use.

Study Design: The current international prospective multicenter cooperative group trial (ClinicalTrials.

Dysfunctional ectopic thyroid gland: a case report.

Introduction: Lingual thyroid gland is a rare anomaly of thyroid gland development, occurring more frequently in females. If it causes local symptomatology such as dysphagia, dysphonia or dyspnea it is diagnosed in childhood, however, if it is asymptomatic it is usually diagnosed in adulthood.

Case Outline: We present a 23-year-old female patient in whom we diagnosed lingual thyroid gland coincidentally during diagnostic procedures of a concomitant disease.

Value of primary tumor gene signatures in colon cancer when national quality standards are adhered to: preliminary results of an international prospective multicenter trial.

Background: The purpose of this study was to determine if gene signatures are informative in colon cancer (CC) when National Quality Standards (NQS) are adhered to. Several studies have demonstrated the prognostic potential of gene signatures in primary CC. This has never been evaluated prospectively with adherence to NQS.

The effectiveness and safety of rescue treatments in 108 patients with steroid-refractory ulcerative colitis with sequential rescue therapies in a subgroup of patients.

Background: Among patients with steroid-refractory ulcerative colitis (UC) in whom a first rescue therapy has failed, a second line salvage treatment can be considered to avoid colectomy.

Aim: To evaluate the efficacy and safety of second or third line rescue therapy over a one-year period.

Methods: Response to single or sequential rescue treatments with infliximab (5mg/kg intravenously (iv) at week 0, 2, 6 and then every 8weeks), ciclosporin (iv 2mg/kg/daily and then oral 5mg/kg/daily) or tacrolimus (0.

Time-dependent estimates of recurrence and survival in colon cancer: clinical decision support system tool development for adjuvant therapy and oncological outcome assessment.

Unanswered questions remain in determining which high-risk node-negative colon cancer (CC) cohorts benefit from adjuvant therapy and how it may differ in an equal access population. Machine-learned Bayesian Belief Networks (ml-BBNs) accurately estimate outcomes in CC, providing clinicians with Clinical Decision Support System (CDSS) tools to facilitate treatment planning. We evaluated ml-BBNs ability to estimate survival and recurrence in CC.

The role of duodenogastric reflux in formation of precarcinogenic gastric lesions--an experimental study.

Introduction: Duodenogastric reflux, commonly encountered as an aftermath of gastroenteroanastomosis, with or without gastric resection (Billroth I, Billroth II), vagotomy and pyloroplastic surgery, is known to cause inflammatory-dystrophic-metaplastic lesions of gastric mucosa. Our objective was to determine the effects of surgery-induced duodenogastric reflux on the development of precarcinogenic lesions or carcinoma in correlation with the reflux duration.

Material And Methods: The experiment was performed on three groups of Wistar rats with 1) Billroth II-induced reflux surgery, 2) resection of the Rouxr-en-Y type reconstruction, and 3) control group with no resection.