Definition, diagnosis and treatment of oligometastatic oesophagogastric cancer: A Delphi consensus study in Europe

Gastric cancer; Metastasectomy; OligometastasisCáncer gástrico; Metastasectomía; OligometástasisCàncer gàstric; Metastasectomia; OligometàstasiBackground Local treatment improves the outcomes for oligometastatic disease (OMD, i.e. an intermediate state between locoregional and widespread disseminated disease). However, consensus about the definition, diagnosis and treatment of oligometastatic oesophagogastric cancer is lacking. The aim of this study was to develop a multidisciplinary European consensus statement on the definition, diagnosis and treatment of oligometastatic oesophagogastric cancer. Methods In total, 65 specialists in the multidisciplinary treatment for oesophagogastric cancer from 49 expert centres across 16 European countries were requested to participate in this Delphi study. The consensus finding process consisted of a starting meeting, 2 online Delphi questionnaire rounds and an online consensus meeting. Input for Delphi questionnaires consisted of (1) a systematic review on definitions of oligometastatic oesophagogastric cancer and (2) a discussion of real-life clinical cases by multidisciplinary teams. Experts were asked to score each statement on a 5-point Likert scale. The agreement was scored to be either absent/poor (<50%), fair (50%–75%) or consensus (≥75%). Results A total of 48 experts participated in the starting meeting, both Delphi rounds, and the consensus meeting (overall response rate: 71%). OMD was considered in patients with metastatic oesophagogastric cancer limited to 1 organ with ≤3 metastases or 1 extra-regional lymph node station (consensus). In addition, OMD was considered in patients without progression at restaging after systemic therapy (consensus). For patients with synchronous or metachronous OMD with a disease-free interval ≤2 years, systemic therapy followed by restaging to consider local treatment was considered as treatment (consensus). For metachronous OMD with a disease-free interval >2 years, either upfront local treatment or systemic treatment followed by restaging was considered as treatment (fair agreement). Conclusion The OMEC project has resulted in a multidisciplinary European consensus statement for the definition, diagnosis and treatment of oligometastatic oesophagogastric adenocarcinoma and squamous cell cancer. This can be used to standardise inclusion criteria for future clinical trials

Definition, diagnosis and treatment of oligometastatic oesophagogastric cancer: A Delphi consensus study in Europe

BACKGROUND Local treatment improves the outcomes for oligometastatic disease (OMD, i.e. an intermediate state between locoregional and widespread disseminated disease). However, consensus about the definition, diagnosis and treatment of oligometastatic oesophagogastric cancer is lacking. The aim of this study was to develop a multidisciplinary European consensus statement on the definition, diagnosis and treatment of oligometastatic oesophagogastric cancer. METHODS In total, 65 specialists in the multidisciplinary treatment for oesophagogastric cancer from 49 expert centres across 16 European countries were requested to participate in this Delphi study. The consensus finding process consisted of a starting meeting, 2 online Delphi questionnaire rounds and an online consensus meeting. Input for Delphi questionnaires consisted of (1) a systematic review on definitions of oligometastatic oesophagogastric cancer and (2) a discussion of real-life clinical cases by multidisciplinary teams. Experts were asked to score each statement on a 5-point Likert scale. The agreement was scored to be either absent/poor (<50%), fair (50%-75%) or consensus (≥75%). RESULTS A total of 48 experts participated in the starting meeting, both Delphi rounds, and the consensus meeting (overall response rate: 71%). OMD was considered in patients with metastatic oesophagogastric cancer limited to 1 organ with ≤3 metastases or 1 extra-regional lymph node station (consensus). In addition, OMD was considered in patients without progression at restaging after systemic therapy (consensus). For patients with synchronous or metachronous OMD with a disease-free interval ≤2 years, systemic therapy followed by restaging to consider local treatment was considered as treatment (consensus). For metachronous OMD with a disease-free interval >2 years, either upfront local treatment or systemic treatment followed by restaging was considered as treatment (fair agreement). CONCLUSION The OMEC project has resulted in a multidisciplinary European consensus statement for the definition, diagnosis and treatment of oligometastatic oesophagogastric adenocarcinoma and squamous cell cancer. This can be used to standardise inclusion criteria for future clinical trials

Magnetic sphincter augmentation and fundoplication for GERD in clinical practice: one-year results of a multicenter, prospective observational study

Abstract Background The techniques available for antireflux surgery have expanded with the introduction of the magnetic sphincter augmentation device (MSAD) for gastroesophageal reflux disease (GERD). Methods A prospective, multicenter registry evaluated MSAD and laparoscopic fundoplication (LF) in clinical practice (ClinicalTrials.gov identifier: NCT01624506). Data collection included baseline characteristics, reflux symptoms, proton-pump inhibitor (PPI) use, side effects, and complications. Post-surgical evaluations were collected at one year. Results At report, 249 patients (202 MSAD patients and 47 LF patients) had completed one-year follow-up. The LF group was older and had a greater frequency of large hiatal hernias and Barrett&apos;s esophagus than the MSAD group (P \ 0.001). The median GERD-health related quality of life score improved from 20.0 to 3.0 after MSAD and 23.0 to 3.5 after LF. Moderate or severe regurgitation improved from 58.2 to 3.1 % after MSAD and 60.0 to 13.0 % after LF (P = 0.014). Discontinuation of PPIs was achieved by 81.8 % of patients after MSAD and 63.0 % after LF (P = 0.009). Excessive gas and abdominal bloating were reported by 10.0 % of patients after MSAD and 31.9 % following LF (P B 0.001). Following MSAD, 91.3 % of patients were able to vomit if needed, compared with 44.4 % of those undergoing LF (P \ 0.001). Reoperation rate was 4.0 % following MSAD and 6.4 % following LF. Conclusion Antireflux surgery should be individualized to the characteristics of each patient, taking into consideration anatomy and propensity and tolerance of side effects. Both MSAD and LF showed significant improvements in reflux control, with similar safety and reoperation rates. In the treatment continuum of antireflux surgery, MSAD should be considered as a first-line surgical option in appropriately selected patients without Barrett&apos;s esophagus or a large hiatal hernia in order to avoid unnecessary dissection and preserve the patient&apos;s native gastric anatomy. MSAD is an important treatment option and will expand the surgeon&apos;s role in treating GERD. The mainstay medical treatment for gastroesophageal reflux disease (GERD), proton-pump inhibitors (PPIs), works by suppressing the production of gastric acid in the stomach to increase the pH level of the refluxed gastric juice Laparoscopic fundoplication (LF) provides mechanical protection from reflux by reconstructing a structurally defective LES using a patient&apos;s own gastric fundus to restore the barrier function at the gastroesophageal junction The magnetic sphincter augmentation device (MSAD, [LINX Ò Reflux Management System Torax Medical; Shoreview, MN]) was developed as an alternative surgery to fundoplication for augmenting the LES in treating GERD In this report, we explore the clinical experience and insights gained from a large multicenter registry that enrolled patients treated with either MSAD or LF in the clinical practice setting to better understand and define the role of MSAD and LF for GERD. Methods Study design Data were obtained from a multicenter, prospective, observational study of antireflux surgical patients (ClinicalTrials.gov identifier: NCT01624506). The study collected data on both the MSAD and LF in clinical practice at 22 medical centers, in four countries (Austria, Germany, Italy, and the United Kingdom). The study allowed enrollment of all patients who were candidates for a surgical antireflux procedure, including patients with advanced GERD defined as meeting one or more of the following conditions: large hiatal hernia ([3 cm diameter of the esophageal hiatus), Barrett&apos;s esophagus, motility disorder, and Grade C or D esophagitis by Los Angeles (LA) classification. Patients without advanced GERD characteristics were considered to have moderate GERD (abnormal esophageal pH, reflux symptoms despite medication). The study was conducted under a common protocol and approved by each center&apos;s Ethics Committee. Informed consent was obtained before enrolling patients into the study. Data collection included baseline characteristics and pre-and post-surgical symptoms, use of PPIs, side effects, and complications. Post-surgical evaluations were collected at one year. Study population As of July 2013, 249 patients had completed the one-year follow-up and were included in this report. Any patient undergoing either the MSAD or LF antireflux surgical procedure was eligible for enrollment in the study. All patients had a diagnosis of GERD confirmed by abnormal esophageal acid exposure on a prolonged pH or pHimpedance study. Further, all patients had chronic reflux symptoms despite the use of medical therapy with PPIs. Patients were excluded if they had known conditions that would make it unlikely for them to complete a 3-year follow-up. Pre-surgical evaluation Patients completed the pre-surgical work-up per standard of care at the participating medical center. Data collected from the medical records included the following: patient demographics, body mass index (BMI), esophagitis grade (LA Classification), esophageal acid exposure as total percent (%) time pH \4, hiatal hernia size, Barrett&apos;s esophagus, distal esophageal contraction amplitude\35 mmHg on wet swallow or \70 % peristaltic sequence, anatomical esophageal abnormalities, history of prior gastroesophageal surgery, allergies to titanium, stainless steel, nickel or ferrous materials, number of years with GERD, and number of years with PPI use. Additionally, a study-related questionnaire was administered to all patients prior to surgery, and these responses served as a comparator to responses obtained one year after surgery to evaluate symptom improvement. The pre-surgical questionnaire included a question regarding the patient&apos;s motivation for having antireflux surgery and the primary reason for selecting either MSAD or LF. Surg Endosc 123 Surgical procedure through discharge The type of antireflux procedure performed (MSAD or LF [Nissen and Toupet]) was provisionally agreed upon by the surgeon in close consultation with the patient, in which the risks and benefits of both procedures were explained in detail. The final choice of procedure was made by the surgeon at the time of laparoscopy, taking into account a variety of factors, including the presence of a large hiatal hernia. Post-operative care was directed by the surgeon based on the patient&apos;s clinical condition and practices of the institution. Data collected for the surgical procedure included procedure time and complications. Additionally, length of hospital of stay, the ability to eat solids food at discharge, and post-operative complications through discharge were tracked. Evaluation of clinical effectives Study-related questionnaires were administered to all patients prior to and one year after surgery. The questionnaires included the GERD-Health Related Quality of Life (GERD-HRQL), an abbreviated Foregut Symptom Questionnaire (FSQ), and a question about reflux interfering with sleep. The GERD-HRQL is a validated, diseasespecific questionnaire composed of ten questions relating to severity of symptoms such as heartburn, dysphagia, odynophagia, bloating, and effect of medications [17]. The total GERD-HRQL score represents a summation of each of the ten items, with a score of 0-5 (most severe). The best possible score is a zero (i.e., asymptomatic in each item), and the worst possible score is 50 (incapacitated in each item). The abbreviated FSQ evaluated severity of regurgitation, extra-esophageal symptoms, ability to belch, and ability to vomit. Use of PPIs was tracked before and after surgery as well as healthcare utilization related to procedural complaints or complications. Additionally, patients were asked about their willingness to undergo surgery again and to rate their post-surgical GERD status as improved, unchanged, or worse since having antireflux surgery. Statistical analysis Data received from clinical sites were entered into a centralized database (Clindex, Fortress Medical Systems). Central monitoring practices were used to generate and resolve queries. Post-surgical data were compared with data collected prior to surgery. Mean and standard deviation (SD) were used to describe continuous variables such as patient demographic data and baseline characteristics. Categorical demographic and baseline variables were summarized via frequency distributions. Clinical effectiveness was evaluated by comparing pre-and postsurgical responses on the patient reported questionnaire. Categorical variables were summarized as frequency counts, percentages and quantitative variables as means and/or medians. The study was not powered to evaluate a study hypothesis. A two-tailed paired Student&apos;s t test or the Wilcoxon signed-rank test was used to compare values before and after surgery. Differences were considered to be significant at the 0.05 level. Results Pre-surgical demographics and characteristics The number of patients reaching the one-year follow-up consisted of 202 MSAD and 47 LF patients. The pre-surgical demographics and characteristics are summarized in Age, large hiatal hernia, and Barrett&apos;s esophagus differed significantly between MSAD and LF. Pre-surgical hiatal hernias[3 cm were 1.6 % in the MSAD group compared to 45.7 % in the LF group (P \ 0.001). More patients in the LF group had Barrett&apos;s esophagus (19.1 % vs. 1.0 %, P \ 0.001). Ninety-four percent of patients in the MSAD group met the definition of moderate GERD (without significant anatomical abnormalities, motility disorders, or Barrett&apos;s esophagus) compared to 38.3 % in the LF group. However, severity symptoms at baseline were similar between the patients who had MSAD versus LF. The mean GERD-HRQL score for MSAD was 20 and for LF it was 23. Moderate/severe regurgitation was reported by 58 and 60 % of patients having MSAD and LF, respectively. Motivations for antireflux surger

European clinical practice guidelines for the definition, diagnosis, and treatment of oligometastatic esophagogastric cancer (OMEC-4)

Introduction: The OligoMetastatic Esophagogastric Cancer (OMEC) project aims to provide clinical practice guidelines for the definition, diagnosis, and treatment of esophagogastric oligometastatic disease (OMD). Methods: Guidelines were developed according to AGREE II and GRADE principles. Guidelines were based on a systematic review (OMEC-1), clinical case discussions (OMEC-2), and a Delphi consensus study (OMEC-3) by 49 European expert centers for esophagogastric cancer. OMEC identified patients for whom the term OMD is considered or could be considered. Disease-free interval (DFI) was defined as the time between primary tumor treatment and detection of OMD. Results: Moderate to high quality of evidence was found (i.e. 1 randomized and 4 non-randomized phase II trials) resulting in moderate recommendations. OMD is considered in esophagogastric cancer patients with 1 organ with ≤ 3 metastases or 1 involved extra-regional lymph node station. In addition, OMD continues to be considered in patients with OMD without progression in number of metastases after systemic therapy. 18F-FDG PET/CT imaging is recommended for baseline staging and for restaging after systemic therapy when local treatment is considered. For patients with synchronous OMD or metachronous OMD and a DFI ≤ 2 years, recommended treatment consists of systemic therapy followed by restaging to assess suitability for local treatment. For patients with metachronous OMD and DFI &gt; 2 years, upfront local treatment is additionally recommended. Discussion: These multidisciplinary European clinical practice guidelines for the uniform definition, diagnosis and treatment of esophagogastric OMD can be used to standardize inclusion criteria in future clinical trials and to reduce variation in treatment.</p

Definition, diagnosis and treatment of oligometastatic oesophagogastric cancer: A Delphi consensus study in Europe

Background: Local treatment improves the outcomes for oligometastatic disease (OMD, i.e. an intermediate state between locoregional and widespread disseminated disease). However, consensus about the definition, diagnosis and treatment of oligometastatic oesophagogastric cancer is lacking. The aim of this study was to develop a multidisciplinary European consensus statement on the definition, diagnosis and treatment of oligometastatic oesophagogastric cancer. Methods: In total, 65 specialists in the multidisciplinary treatment for oesophagogastric cancer from 49 expert centres across 16 European countries were requested to participate in this Delphi study. The consensus finding process consisted of a starting meeting, 2 online Delphi questionnaire rounds and an online consensus meeting. Input for Delphi questionnaires consisted of (1) a systematic review on definitions of oligometastatic oesophagogastric cancer and (2) a discussion of real-life clinical cases by multidisciplinary teams. Experts were asked to score each statement on a 5-point Likert scale. The agreement was scored to be either absent/poor (2 years, either upfront local treatment or systemic treatment followed by restaging was considered as treatment (fair agreement). Conclusion: The OMEC project has resulted in a multidisciplinary European consensus statement for the definition, diagnosis and treatment of oligometastatic oesophagogastric adenocarcinoma and squamous cell cancer. This can be used to standardise inclusion criteria for future clinical trials

Definition, diagnosis and treatment of oligometastatic oesophagogastric cancer: A Delphi consensus study in Europe

Background: Local treatment improves the outcomes for oligometastatic disease (OMD, i.e. an intermediate state between locoregional and widespread disseminated disease). However, consensus about the definition, diagnosis&nbsp;and treatment of oligometastatic oesophagogastric cancer is lacking. The aim of this study was to develop a multidisciplinary European consensus statement on the definition, diagnosis&nbsp;and treatment of oligometastatic oesophagogastric cancer. Methods: In total, 65 specialists in the multidisciplinary treatment for oesophagogastric cancer from 49 expert centres across 16 European countries were requested to participate in this Delphi study. The consensus finding process consisted of a starting meeting, 2 online Delphi questionnaire rounds&nbsp;and an online consensus meeting. Input for Delphi questionnaires consisted of (1) a systematic review on definitions of oligometastatic oesophagogastric cancer&nbsp;and (2) a discussion of real-life clinical cases by multidisciplinary teams. Experts were asked to score each statement on a 5-point Likert scale. The agreement was scored to be either absent/poor (&lt;50%), fair (50%-75%)&nbsp;or consensus (≥75%). Results: A total of 48 experts participated in the starting meeting, both Delphi rounds, and the consensus meeting (overall response rate: 71%). OMD was considered in patients with metastatic oesophagogastric cancer limited to 1 organ with ≤3 metastases or 1 extra-regional lymph node station (consensus). In addition, OMD was considered in patients without progression at restaging after systemic therapy (consensus). For patients with synchronous or metachronous OMD with a disease-free interval ≤2 years, systemic therapy followed by restaging to consider local treatment was considered as treatment (consensus). For metachronous OMD with a disease-free interval &gt;2 years, either upfront local treatment or systemic treatment followed by restaging was considered as treatment (fair agreement). Conclusion: The OMEC project has resulted in a multidisciplinary European consensus statement for the definition, diagnosis and treatment of oligometastatic oesophagogastric adenocarcinoma and squamous cell cancer. This can be used to standardise inclusion criteria for future clinical trials