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Objective: The aim was to develop a reliable surgical quality assurance system for 2-stage esophagectomy. This development was conducted during the pilot phase of the multicenter ROMIO trial, collaborating with international experts., Summary of Background Data: There is evidence that the quality of surgical performance in randomized controlled trials influences clinical outcomes, quality of lymphadenectomy and loco-regional recurrence., Methods: Standardization of 2-stage esophagectomy was based on structured observations, semi-structured interviews, hierarchical task analysis, and a Delphi consensus process. This standardization provided the structure for the operation manual and video and photographic assessment tools. Reliability was examined using generalizability theory., Results: Hierarchical task analysis for 2-stage esophagectomy comprised fifty-four steps. Consensus (75%) agreement was reached on thirty-nine steps, whereas fifteen steps had a majority decision. An operation manual and record were created. A thirty five-item video assessment tool was developed that assessed the process (safety and efficiency) and quality of the end product (anatomy exposed and lymphadenectomy performed) of the operation. The quality of the end product section was used as a twenty seven-item photographic assessment tool. Thirty-one videos and fifty-three photographic series were submitted from the ROMIO pilot phase for assessment. The overall G-coefficient for the video assessment tool was 0.744, and for the photographic assessment tool was 0.700., Conclusions: A reliable surgical quality assurance system for 2-stage esophagectomy has been developed for surgical oncology randomized controlled trials., Ethical Approval: 11/NW/0895 and confirmed locally as appropriate, 12/SW/0161, 16/SW/0098.Trial registration number: ISRCTN59036820, ISRCTN10386621., Competing Interests: The authors declare no conflict of interests., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Introduction: Surgery (oesophagectomy), with neoadjuvant chemo(radio)therapy, is the main curative treatment for patients with oesophageal cancer. Several surgical approaches can be used to remove an oesophageal tumour. The Ivor Lewis (two-phase procedure) is usually used in the UK. This can be performed as an open oesophagectomy (OO), a laparoscopically assisted oesophagectomy (LAO) or a totally minimally invasive oesophagectomy (TMIO). All three are performed in the National Health Service, with LAO and OO the most common. However, there is limited evidence about which surgical approach is best for patients in terms of survival and postoperative health-related quality of life., Methods and Analysis: We will undertake a UK multicentre randomised controlled trial to compare LAO with OO in adult patients with oesophageal cancer. The primary outcome is patient-reported physical function at 3 and 6 weeks postoperatively and 3 months after randomisation. Secondary outcomes include: postoperative complications, survival, disease recurrence, other measures of quality of life, spirometry, success of patient blinding and quality assurance measures. A cost-effectiveness analysis will be performed comparing LAO with OO. We will embed a randomised substudy to evaluate the safety and evolution of the TMIO procedure and a qualitative recruitment intervention to optimise patient recruitment. We will analyse the primary outcome using a multi-level regression model. Patients will be monitored for up to 3 years after their surgery., Ethics and Dissemination: This study received ethical approval from the South-West Franchay Research Ethics Committee. We will submit the results for publication in a peer-reviewed journal., Trial Registration Number: ISRCTN10386621., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Randomised controlled trials (RCTs) in surgery are frequently criticised because surgeon expertise and standards of surgery are not considered or accounted for during study design. This is particularly true in pragmatic trials (which typically involve multiple centres and surgeons and are based in 'real world' settings), compared with explanatory trials (which are smaller and more tightly controlled)., Objective: This protocol describes a process to develop and test quality assurance (QA) measures for use within a predominantly pragmatic surgical RCT comparing minimally invasive and open techniques for oesophageal cancer (the NIHR ROMIO study). It builds on methods initiated in the ROMIO pilot RCT., Methods and Analysis: We have identified three distinct types of QA measure: (i) entry criteria for surgeons, through assessment of operative videos, (ii) standardisation of operative techniques (by establishing minimum key procedural phases) and (iii) monitoring of surgeons during the trial, using intraoperative photography to document key procedural phases and standardising the pathological assessment of specimens. The QA measures will be adapted from the pilot study and tested iteratively, and the video and photo assessment tools will be tested for reliability and validity., Ethics and Dissemination: Ethics approval was obtained (NRES Committee South West-Frenchay, 25 April 2016, ref: 16/SW/0098). Results of the QA development study will be submitted for publication in a peer-reviewed journal., Trial Registration Number: ISRCTN59036820, ISRCTN10386621., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)

Background: Oesophageal cancer is increasing in incidence worldwide. Minimally invasive techniques have been used to perform oesophagectomy, but concerns regarding these techniques remain. Since its description by Cuschieri in 1992, the use of minimally invasive oesophagectomy (MIO) has increased, but still only used in a minority of resections in the UK in 2009. In particular, there has been reluctance to use minimally invasive (thoracoscopic and laparoscopic) techniques in more advanced cancers for fears regarding the adequacy of the oncological resection. In order to identify any factors that could affect survival, we undertook a retrospective analysis on all patients who underwent surgery in our department over an 8-year period., Methods: A retrospective data analysis was undertaken on all patients who underwent oesophagectomy in a tertiary upper gastrointestinal surgery unit, from 2005 to 2012 inclusive. Data were collected from the departmental database and case note review, with follow-up and survival data to time of data collection. The survival data were analysed using univariate and multivariate Cox proportional hazard regression models to determine which variables affected survival. Variables examined included age, tumour position, tumour stage (T0, 1, 2 vs T3, 4), nodal stage (N0 vs N1), tumour histology, completeness of resection (R0 vs R1), use of neoadjuvant chemotherapy and operative technique (thoracoscopic/laparoscopic (MIO) vs laparoscopic abdomen/open chest (Lap assisted) vs Open., Results: 334 patients underwent oesophagectomy between 2005 and 2012. Male to female ratio was 3.75:1, with a mean age of 64 years (range 36-87). There were 83 open oesophagectomies, 187 laparoscopically assisted oesophagectomies and 64 minimally invasive oesophagectomies. Following univariate regression analysis the following factors were found to be correlated to survival: use of neoadjuvant chemotherapy (Hazard Ratio 2.889, 95 % CI 1.737-4.806), T stage 3 or 4 (3.749, 2.475-5.72), Node positive (5.225, 3.561-7.665), R1 resection (2.182, 1.425-3.341), type of operation (MIO compared to open oesophagectomy) (0.293, 0.158-0.541). There was no significant relationship between age, tumour position or tumour histology and length of survival. When these factors were entered into a multivariate model, the independently significant factors correlated to survival were found to be T stage 3 or 4 (HR 1.969, 1.248-3.105), Node positive (3.833, 2.548-5.766) and type of operation (MIO compared to open) (0.5186, 0.277-0.972)., Conclusion: Multiple small studies have found reduced pulmonary complication rates and duration of hospital stay when using a minimally invasive approach compared to open. Concerns in the literature over long-term outcomes, however, have led to limited utilisation of this method, especially in advanced disease. The data from this large study show significantly better survival following operations performed using minimally invasive techniques compared to open, however, we have not adjusted for some known or unknown confounding factors. International and national RCTs, however, will provide more information in due course.

Background: The optimal treatment for localised oesophageal squamous cell carcinoma (SCC) is uncertain. We assessed the feasibility of an RCT comparing neoadjuvant treatment and surgery with definitive chemoradiotherapy., Methods: A feasibility RCT in three centres examined incident patients and reasons for ineligibility using multi-disciplinary team meeting records. Eligible patients were offered participation in the RCT with integrated qualitative research involving audio-recorded recruitment appointments and interviews with patients to inform recruitment training for staff., Results: Of 375 patients with oesophageal SCC, 42 (11.2%) were eligible. Reasons for eligibility varied between centres, with significantly differing proportions of patients excluded because of total tumour length (P=0.002). Analyses of audio-recordings and patient interviews showed that recruiters had challenges articulating the trial design in simple terms, balancing treatment arms and explaining the need for randomisation. Before analyses of the qualitative data and recruiter training no patients were randomised. Following training in one centre 5 of 16 eligible patients were randomised., Conclusions: An RCT of surgical vs non-surgical treatment for SCC of the oesophagus is not feasible in the UK alone because of the low number of incident eligible patients. A trial comparing diverse treatment approaches may be possible with investment to support the recruitment process.

Background: There is a need for evidence of the clinical effectiveness of minimally invasive surgery for the treatment of esophageal cancer, but randomized controlled trials in surgery are often difficult to conduct. The ROMIO (Randomized Open or Minimally Invasive Oesophagectomy) study will establish the feasibility of a main trial which will examine the clinical and cost-effectiveness of minimally invasive and open surgical procedures for the treatment of esophageal cancer., Methods/design: A pilot randomized controlled trial (RCT), in two centers (University Hospitals Bristol NHS Foundation Trust and Plymouth Hospitals NHS Trust) will examine numbers of incident and eligible patients who consent to participate in the ROMIO study. Interventions will include esophagectomy by: (1) open gastric mobilization and right thoracotomy, (2) laparoscopic gastric mobilization and right thoracotomy, and (3) totally minimally invasive surgery (in the Bristol center only). The primary outcomes of the feasibility study will be measures of recruitment, successful development of methods to monitor quality of surgery and fidelity to a surgical protocol, and development of a core outcome set to evaluate esophageal cancer surgery. The study will test patient-reported outcomes measures to assess recovery, methods to blind participants, assessments of surgical morbidity, and methods to capture cost and resource use. ROMIO will integrate methods to monitor and improve recruitment using audio recordings of consultations between recruiting surgeons, nurses, and patients to provide feedback for recruiting staff., Discussion: The ROMIO study aims to establish efficient methods to undertake a main trial of minimally invasive surgery versus open surgery for esophageal cancer., Trial Registration: The pilot trial has Current Controlled Trials registration number ISRCTN59036820(25/02/2013) at http://www.controlled-trials.com; the ROMIO trial record at that site gives a link to the original version of the study protocol.

Background: Minimally invasive esophagectomy (MIE) may lead to early restoration of health-related quality of life, but few prospective comparative studies have been performed. This exploratory study compared recovery between totally minimally invasive esophagectomy (MIE), laparoscopically assisted esophagectomy (LAE) and open surgery (OE)., Methods: A prospective study in 2 specialist centers recruited consecutive patients undergoing OE, LAE, or MIE for high-grade dysplasia or cancer. Patients completed validated questionnaires, the Multi-Dimensional Fatigue Inventory (MFI-20), modified Katz Scale, and modified Lawton and Brody Scale (assessing activities of daily living) before and 6 weeks and 3 and 6 months after surgery., Results: A total of 97 patients (26 women; median age 64 years) were scheduled for surgery that was abandoned in 11 due to occult low-volume metastatic disease. In the remaining 86 (OE = 19, LAE = 31, and MIE = 36), there were 4 in-hospital deaths (4 %), and 54 postoperative complications (OE = 12, LAE = 19, and MIE = 23). Overall questionnaire compliance was high (77 %) and baseline scores similar in all groups, although clinical differences between groups were observed with earlier tumors and more squamous cell cancers selected for MIE. Following surgery fatigue levels increased dramatically and activity levels reduced in all groups. These gradually recovered to baseline following MIE and LAE within 6 months, but the ability to perform activities of daily living and most parameters of fatigue had not returned to baseline levels in the OE group., Conclusions: This exploratory prospective nonrandomized study of recovery after different types of surgery for esophageal cancer showed possible small benefits to MIE. A much larger study is needed to confirm these findings.

Background: The Idea, Development, Evaluation, Assessment and Long term study (IDEAL) framework makes recommendations for evaluating and reporting surgical innovation and adoption, but remains untested., Methods: A prospective database was created for the introduction of minimally invasive techniques for oesophagectomy. IDEAL stages of development and evaluation were examined retrospectively in a series of patients undergoing laparoscopically assisted oesophagectomy (LAO), two- or three-phase minimally invasive oesophagectomy (MIO) and open oesophagectomy., Results: A total of 192 patients were involved. In IDEAL stages 1 and 2a, LAO in 16 patients was uneventful, but two-phase MIO in six patients was abandoned following consecutive technical complications. Two-phase MIO was modified to a three-phase MIO procedure, and the results of LAO (67 patients), three-phase MIO (35) and open techniques (68) were studied in IDEAL stage 2b. Major complications (Clavien-Dindo grades III and IV) occurred in 12 (18 per cent), nine (26 per cent) and 14 (21 per cent) LAO, three-phase MIO and open procedures respectively. There were four in-hospital deaths (2 LAO and 2 open)., Conclusion: The IDEAL framework is a feasible method for documenting the development and implementation of a procedure. MIO should now be compared with open surgery in a randomized controlled trial (IDEAL stage 3)., (Copyright © 2011 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.)

Multidisciplinary cancer teams offer many theoretical benefits, although few have been formally examined. This study evaluated the role of multidisciplinary team (MDT) meetings in recruitment into randomised controlled trials (RCTs). Consecutive MDT patient records were categorised into those with or without a recommendation for a national multicentre RCT. Clinical trial office records identified whether patients were subsequently screened and randomised. In 125 MDT meetings, 350 new patients were discussed, of whom 103 were potentially suitable for a RCT. The MDT recommended 68 patients for the trial, of whom 58 (85%) were screened for trial eligibility. Of the 35 without an MDT trial recommendation, only 23 (66%) were screened (p=0.022). This difference persisted and resulted in a greater proportion of MDT recommended patients being recruited (65% versus 49%; p=0.12). This study demonstrates that trial recommendation by an MDT significantly increases trial screening rates and may improve recruitment.

Background: Tumours of the gastro-oesophageal junction may be resected by total gastrectomy (TG) or transthoracic oesophagectomy (TTO). This study compared health-related quality of life (HRQL) following these procedures., Methods: Prospective clinical and HRQL data (European Organization for Research and Treatment of Cancer QLQ-C30) were collected from 63 consecutive patients (20 TG and 43 TTO) before and 6 months after surgery for Siewert type I-III gastro-oesophageal tumours., Results: Questionnaire response rates exceeded 90 per cent. Patients were similar with respect to disease stage, treatment-related mortality and survival, but those selected for TTO were younger with less co-morbidity than those undergoing TG. These differences were reflected in baseline HRQL scores, which were better in patients selected for TTO. Six months after surgery, however, HRQL showed a greater deterioration after TTO than after TG in terms of role and social function, global quality of life and fatigue. Symptom scores for pain and diarrhoea increased in both groups., Conclusion: TTO had a greater negative impact on HRQL than TG for tumours of the gastro-oesophageal junction., (Copyright (c) 2007 British Journal of Surgery Society Ltd.)

Background: Combination chemoradiotherapy with or without surgery are internationally applied alternative strategies for potential cure of oesophageal cancer. This study compared health-related quality of life (HRQL) between patients selected for chemoradiation and those who had combination treatment including oesophagectomy., Methods: Patients with stage II or III oesophageal cancer completed HRQL assessments at baseline, at the worst expected HRQL time point and at expected recovery. HRQL was compared between groups using linear regression, adjusting for age, sex, performance status, tumour stage and type, and baseline HRQL., Results: Some 132 patients began treatment, of whom 51 had chemoradiotherapy and 81 combination treatment including surgery. Patients selected for chemoradiotherapy were older, more likely to have squamous cell cancer and reported poorer HRQL than those selected for surgery. At the worst expected time point after treatment, both groups reported multiple symptoms and poor function, but surgery was associated with a greater reduction in HRQL from baseline than chemoradiotherapy. Recovery of HRQL was achieved within 6 months after chemoradiotherapy, but complete recovery had not occurred 6 months after surgery and there was persistent significant deterioration in some aspects., Conclusion: The negative treatment-related impact of chemoradiation on short-term HRQL is less than that experienced with combination treatment including surgery. Patients preferring early recovery should consider definitive chemoradiation., (Copyright (c) 2007 British Journal of Surgery Society Ltd.)

Background: Little is known regarding the long-term, health-related quality of life (HRQL) of survivors of esophagectomy for cancer., Methods: Consecutive patients completed the validated European Organization for Research and Treatment of Cancer general quality-of life-questionnaire (QLQ-C30) and the esophageal-specific module (QLQ-OES18) before surgery and regularly thereafter for at least 3 years. Mean scores with 95% confidence intervals were calculated. The Student t test for paired data was used to determine differences between baseline and 3-year HRQL scores in which scores differed by >or=5 points., Results: Of 90 patients who underwent surgery, 47 patients (52%) survived for >or=3 years. In this group, most aspects of HRQL recovered to preoperative levels by the 3-year assessment, except that scores for physical function, breathlessness, diarrhea, and reflux were significantly worse than at baseline (P < .01). However, patients reported significantly better emotional function 3 years after surgery than before treatment (P = .0008)., Conclusions: Even after 3 years, patients who underwent esophagectomy suffered persistent problems with physical function and specific symptoms. These findings may be used to inform patients of the long-term consequences of surgery., ((c) 2007 American Cancer Society.)

Background: Outcomes for treatment for upper gastrointestinal cancer traditionally include procedure-related morbidity and mortality and long-term survival. Patient-reported outcomes, such as quality of life (QOL) and satisfaction measures, add to standard end points, but associations between these factors are not fully understood. This study examined how patient satisfaction related to surgical morbidity, treatment type, and QOL outcomes after inpatient treatment for upper gastrointestinal cancer., Methods: Consecutive patients who had completed treatment in one unit were invited to participate in this study and complete the European Organization for Research and Treatment of Cancer QLQ-PATSAT32 and QLQ-C30 questionnaires within 2 months of discharge. Regression analyses examined relationships between satisfaction and surgical morbidity (major complications and type of treatment) and between satisfaction and QOL variables, adjusting for age and sex., Results: During the study, 181 patients were treated, 162 were eligible, and 139 returned both questionnaires (response rate, 86%). Of the study sample, the treatment outcome was potential cure in 105 (67 esophagectomy and 38 D2 gastrectomy), and 34 received palliative treatment. Thirty-seven patients (27%) had major complications. Patients who received palliative treatment reported satisfaction and QOL scores similar to those of patients who received curative treatment. However, patients who experienced major morbidity reported significantly worse QOL than those without morbidity (P<.01). Satisfaction scores were the same in patients with or without complications. There were no associations between satisfaction and QOL scores (r<.34)., Conclusions: Patient satisfaction with hospital care is independent of morbidity, treatment type, and QOL outcomes. It may be used to feed back information to providers of health care to improve patients' experiences of treatment.

Background: Evidence suggests that baseline quality of life (QOL) scores are independently prognostic for survival in patients with cancer, but the role of QOL data in predicting short-term outcome after surgery is uncertain. This study assessed the association between QOL scores and short-term outcomes after surgery for oesophageal and gastric cancer., Methods: Consecutive patients selected for oesophagectomy or total gastrectomy between November 2000 and May 2003 completed the European Organization for Research and Treatment of Cancer's quality of life questionnaire, QLQ-C30. Multivariable regression models, adjusting for known clinical risk factors, were used to investigate relationships between QOL scores, major morbidity, hospital stay and survival status at 6 months., Results: Of 130 patients, 121 completed the questionnaire (response rate 93.1 per cent). There were 29 major complications (24.0 per cent) and 22 patients (18.2 per cent) died within 6 months of operation. QOL scores were not associated with major morbidity but were significantly related to survival status at 6 months after adjusting for known clinical risk factors. A worse fatigue score of 10 points (scale 0-100) corresponded to an increase in the odds of death within 6 months of surgery of 37.4 (95 per cent confidence interval (c.i.) 12.4 to 67.8) per cent (P = 0.002). Pretreatment social function scores were moderately associated with hospital stay (P = 0.021); a reduction in social function by 10 points corresponded to an increase in hospital stay of 0.93 (95 per cent c.i. 0.12 to 1.74) days., Conclusion: QOL scores supplement standard staging procedures for oesophageal and gastric cancer by providing prognostic information, but they do not contribute to perioperative risk assessment., (Copyright (c) 2005 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.)

Background: Patients' views are becoming increasingly important in the current health system. They provide information on effectiveness of healthcare and how it may be improved. This study aimed to measure patients' satisfaction with care received for treatment of oesophageal and gastric cancer, and to identify areas that contribute most to overall satisfaction scores., Methods: Consecutive inpatients with oesophageal and gastric cancer treated in one surgical unit were recruited prospectively during a 2-year period. The European Organization for Research and Treatment of Cancer 'satisfaction with in-hospital care' questionnaire (QLQ-SAT32) was completed following discharge. Scores ranged from 0 to 100 for each satisfaction scale. Univariable and multivariable analysis was used to define the relationships between the different dimensions of satisfaction with care and the overall score., Results: Ninety-one patients (mean age 67 years, 60 men) completed the questionnaire a mean of 40 days after treatment. The highest scores were for doctors (mean 72), nurses (mean 67) and overall satisfaction (mean 68). Univariable analysis showed that all dimensions of satisfaction with care contributed significantly to overall satisfaction (P < 0.001). Multivariable analyses, however, showed that most of the variation in overall satisfaction could be attributed to levels of satisfaction with doctors, nurses, and hospital comfort and cleanliness., Conclusion: Satisfaction with care in these surgical patients was high and could be measured using a multidimensional instrument. Overall satisfaction was not influenced equally by all aspects of care. The strongest contributors to overall satisfaction in this study were doctors, nurses and hospital cleanliness., (Copyright 2004 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.)

AIMS: The benefit of extended lymphadenectomy in patients with squamous cell carcinoma of the oesophagus is established, but there is little evidence to support this in patients with adenocarcinoma. The aim of this study was to investigate the extent of lymphatic spread of oesophageal adenocarcinomas, and particularly the proximal spread in tumours located in the mid thorax. METHODS: Twenty-six consecutive patients with tumours arising between 29 and 35 cm from the incisor teeth underwent three-stage oesophagectomy with two-field lymphadenectomy, including nodes in the recurrent laryngeal chains. The proximal extent was measured by endoscopic ultrasonography and confirmed at operation, with division of the lymph node harvest into anatomical sites according to the Japanese classification of oesophageal cancer. RESULTS: There were 21 men and five women, with a mean age of 64 (range 42-78) years; seven patients were lymph node negative in both the mediastinal and abdominal fields. Six patients had nodal metastases more than 2 cm above the tumour and all had extensive involvement of other nodes at the level of the tumour or below, with 7, 7, 9, 12, 15 and 18 nodes positive. There were no patients in whom nodes above the tumour contained metastases while those at the level or below were clear. CONCLUSIONS: Dissection of proximal lymph nodes along the recurrent laryngeal nerve chains in patients with adenocarcinoma of the oesophagus is not warranted. Lymphatic spread above the level of the tumour occurs in association with extensive lymph node involvement elsewhere and removal of proximal nodes from difficult locations is not warranted as a means of improving staging or survival.

Background and Study Aims: The aim of this study was to assess whether the use of laser ablation could palliate or potentially cure ampullary carcinoma., Patients and Methods: This study involved patients with confirmed ampullary carcinomas who were deemed fit for repeated endoscopic treatment but who were unfit for more radical treatment, and included six patients in Oxford and six in Gloucester. Repeated laser therapy was used after endoscopic stenting, following investigation as described., Results: Good periods of survival were seen with good palliation and no complications of treatment. The longest survival was 36 months (range 4-36, median 21). Duodenal obstruction was successfully relieved in one patient., Conclusion: The treatment shows promise in selected patients, but conclusions are limited by the small numbers and lack of controls in this study.

Columnar metaplasia of the lower esophageal epithelium (Barrett's esophagus) occurs in response to acid reflux, and its most important long-term complication is malignancy. In view of this, techniques are being explored for the eradication of Barrett's esophagus, and histopathologists will increasingly be required to assess response to these therapies in esophageal biopsy samples. The histopathologic features before and after treatment were studied in biopsy samples from 16 patients receiving omeprazole only, 10 treated by KTP laser photoablation, and five who underwent photodynamic therapy. All the treatment modalities resulted in histologic changes with at least partial squamous reepithelialization of the metaplastic columnar epithelium. The histologic findings suggest three main mechanisms for this: encroachment of adjacent squamous epithelium at the squamocolumnar junction, extension of epithelium from the submucosal gland duct to form squamous islands, and squamous metaplasia within the Barrett's columnar mucosa itself. The latter mechanism implies the existence of pluripotential stem cells within Barrett's mucosa. A relatively common finding was residual glandular mucosa, nonneoplastic and dysplastic, beneath squamous epithelium indicating the requirement for histologic confirmation of endoscopically suspected complete squamous reepithelialization with sufficiently deep biopsies.

Background: Barrett's oesophagus is acquired by severe gastro-oesophageal reflux and is a premalignant condition. Acid suppression or anti-reflux surgery alone do not cause significant regression of the metaplastic mucosa nor reduce the malignant potential. Recent reports have suggested that the combination of mucosal ablation with acid suppression may result in squamous regeneration., Aims: To destroy Barrett's mucosa by thermal ablation (in the setting of acid suppression) and so induce squamous regeneration., Patients: Sixteen patients with non-dysplastic Barrett's oesophagus were recruited from a surveillance programme. All had been on a proton pump inhibitor., Methods: At intervals, non-circumferential areas of columnar mucosa were ablated using the KTP laser. Acid suppression was obtained with 40 mg omeprazole daily. Multiple biopsy specimens were obtained for histological examination from ablated areas., Results: Ablation of all areas of glandular mucosa resulted in squamous regeneration. The number of treatments required depended on the length of the Barrett's segment. In 11 patients there was evidence of squamous regeneration over remaining Barrett's glands (in some of the post-treatment biopsy specimens) whilst in nine patients squamous metaplasia was seen within Barrett's glands., Conclusion: Mucosal ablation of Barrett's oesophagus by laser, in the setting of acid suppression, results in squamous regeneration (though some burying of Barrett's glands did occur).

Background: Diffuse oesophageal spasm (DOS) is a potential cause of intermittent chest pain and/or dysphagia. In the past, the diagnosis of DOS has relied on criteria obtained from standard oesophageal manometry (more than one simultaneous contraction in a series of 10 wet swallows with the rest being peristaltic). As symptoms are intermittent, however, 24 hour manometry may well be more suited to its investigation., Aims: To determine the ability of 24 hour manometry to detect the symptomatic contractions of DOS and to compare standard, laboratory based manometry with 24 hour manometry in its diagnosis., Patients: Three hundred and ninety consecutive patients referred with suspected oesophageal disorders., Methods: Standard laboratory based manometry and 24 hour outpatient manometry., Results: Sixteen patients were classified by 24 hour manometry as having DOS on the basis of painful contractions (spasms) of excessive duration and increased amplitude. Laboratory based manometry failed to detect the majority of these patients with DOS (14/16), and 53/55 were incorrectly labelled as having DOS on the basis of asymptomatic manometric findings., Conclusion: The detection of symptomatic DOS requires 24 hour manometry.

TNM staging of oesophageal cancer provides significant prognostic information but its clinical impact is limited as many patients present with advanced disease (i.e. T3N1). Additional prognostic markers may help separate those with 'good' and 'bad' prognosis tumours and so help with decisions such as selection for adjuvant therapy. p53 and c-erbB-2 overexpression may correlate with poor prognosis in oesophageal cancer, but this is uncertain. This study aimed to investigate the value of these biomarkers as prognostic indicators in resected oesophageal cancer. Two hundred and five oesophageal tumours (127 adenocarcinoma, 78 squamous) resected by a single surgeon between June 1979 and January 1991 were investigated for p53 and c-erbB-2 overexpression using DO-7 and CB-11 immunohistochemistry. Patient survival was analysed by Kaplan-Meir life tables. Median survival was 61 weeks (range: 5-747) and survival diminished significantly with increasing UICC stage (P < 0.0001). Sixty-eight per cent of squamous tumours and 66% of adenocarcinomas overexpressed p53 but there was no statistically significant correlation with prognosis. Twenty-six per cent of squamous tumours and 23% of adenocarcinomas overexpressed c-erbB-2, but again this did not correlate with survival. p53 and c-erbB-2 are commonly overexpressed in oesophageal cancer but do not appear to be related to prognosis in this large series of resected oesophageal cancers and other candidate biomarkers must be sought.

Previous studies of the mechanisms that precipitate acid reflux episodes have used short term hospital based measurements. A 24 hour pH and motility recording system, incorporating a sphincter monitoring device, has been developed to study naturally occurring acid reflux episodes in control subjects and patient groups with different grades of oesophagitis. Lower oesophageal sphincter relaxations related to episodes of acid reflux were common in control subjects (67% of episodes) but became more difficult to detect as the grade of oesophagitis increased (grade 0/1 - 67%, grade 2/3 - 35%, grade 4 - 13%). A variety of events that produced recognisable transdiaphragmatic pressure patterns were associated with acid reflux episodes. In control subjects 74% of acid reflux episodes were precipitated by belching but this mechanism became less evident as the grade of oesophagitis increased (grade 0/1 - 43%, grade 2/3 - 40%, grade 4 - 29%). Activities that produced a pressure gradient across the diaphragm became increasingly important as events precipitating acid reflux as oesophagitis became more severe (controls--2%, grade 0/1 - 15%, grade 2/3 - 11%, grade 4 - 22%). This study has shown the pressure events surrounding acid reflux in fully ambulant patients with gastro-oesophageal reflux disease.

Previous studies examining oesophageal acid clearance have employed a variety of techniques to induce or simulate acid reflux. Clearance abnormalities have been deduced from abnormal standard motility studies, barium radiology or from 24-h pH recordings. In this study a 24-h pH and oesophageal motility recording system was used to study naturally occurring acid reflux episodes in control subjects and in two groups of patients with severe acid reflux disease (erosive oesophagitis and oesophageal stricture). Acid clearance was compared between the subject groups. Patients with oesophageal stricture were found to have poor oesophageal peristaltic ability and particularly poor oesophageal acid clearance. Those with erosive oesophagitis had normal peristaltic swallowing but abnormal acid clearance. This study has characterized, for the first time, the abnormalities in acid clearance during naturally occurring acid reflux episodes in patients with severe reflux disease. A more complete understanding of these clearance abnormalities could influence future medical and surgical strategies in the management of severe gastro-oesophageal reflux disease.

A total of 118 patients on a waiting list for a transurethral prostatectomy, who had been selected primarily on the basis of their symptoms and the finding of an enlarged prostate, were reassessed by objective tests. Of the 107 finally studied, 44% were retained on the waiting list and a further 8% kept under review; 48% were discharged from any further follow-up. The study reinforces the importance of objectively assessing patients presenting with urinary symptoms.

Previous studies of the mechanisms that precipitate acid reflux episodes and acid clearance have used unphysiological, short term hospital based data. A new 24 hour pH and motility recording system combined with computerised data analysis have been used to study naturally occurring acid reflux episodes in healthy ambulant volunteers. A variety of events that produced recognisable transdiaphragmatic pressure patterns were associated with acid reflux episodes (particularly belching). Peristaltic waves were the predominant contractions leading to oesophageal acid clearance and were the commonest contraction type during reflux episodes. Peristaltic wave parameters (amplitude, velocity, frequency, and percentage proportion) varied during different periods of the 24 hour recording. This study has produced new information about 24 hour oesophageal function and naturally occurring acid reflux which will provide a basis for comparison with patients with gastro-oesophageal reflux disease.

Conventional oesophageal manometric studies are open to criticism in that they take place on fasted immobile subjects in the artificial setting of a motility laboratory. A new 24-h pH and motility recording system combined with computerized data analysis was used to study patients with gastro-oesophageal reflux disease and oesophageal motor abnormalities under ambulant conditions. Acid reflux episodes were found to be precipitated by a variety of events with recognizable pressure patterns. Acid clearance abnormalities were demonstrated in patients with erosive oesophagitis but were confined to those with abnormal oesophageal motor function. Improved diagnostic accuracy was demonstrated in the recognition of oesophageal motor disorders.

Current evidence suggests that lower oesophageal sphincter (LOS) competence depends upon both pressure and length. Existing devices can measure length and pressure, but not simultaneously. This methodological problem is a fundamental drawback to understanding LOS function and its role in oesophageal disease. A 'sphinctometer' has been developed, consisting of an oil-filled 3-mm diameter Silastic chamber, 6 cm in length, incorporating a pressure microtransducer designed to provide an integrated pressure reading as a function of length. Its performance has been tested in vitro using human cadaver oesophagus in a specially constructed chamber in which sphincter length and pressure can be varied independently. Comparisons were made with a conventional pull-through technique. Sphinctometer response was linear throughout the LOS pressure range of 0 to 50 mmHg at a fixed LOS length (RS = 0.99; P less than 0.001). Sphinctometer response was also linear at fixed LOS pressure for sphincter lengths from 1 to 6 cm (RS = 0.99; P less than 0.001). This device thus appeared suitable for monitoring function of the human LOS, and has subsequently been successfully incorporated into an ambulatory system for patient use.