Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Barrett Esophagus

Precancerous Conditions

Esophageal Diseases

Gastrointestinal Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Esophageal Cancer

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Antipyretics

Anti-Inflammatory Agents

Antirheumatic Agents

Fibrinolytic Agents

Platelet Aggregation Inhibitors

Anesthetics

Aspirin

Anti-Inflammatory Agents, Non-Steroidal

Proton Pump Inhibitors

While surgical reference technique for invasive cancer of the lower esophagus is the technique according to Lewis Santy, there is no consensus on the technique and surgical approaches lack of specific work in the particular case of superficial lesions . The centers will have the choice of using the technique according to Lewis Santy with gastric plasty or technique of esophagectomy without thoracotomy with lower mediastinal dissection. In the absence of consensus to date available, abdominal surgery time will be by laparotomy or laparoscopy (laparoscopic assisted technique called). In both cases, an exploratory laparoscopy for diagnostic purposes is realized to remove an extension of the disease that would indicate against-resection with curative intent. For surgery, patients will be put under antisecretory therapy proton-pump inhibitor; this at least throughout the duration of the study.

The equipment processing is:

* The radiofrequency generator,
* The radiofrequency balloon 360,
* the radiofrequency probe 90.

The radiofrequency treatment should be carried out according to the following protocol:

* The radiofrequency treatment is done within 2 months following the last endoscopic assessment.
* The maximum number of sessions is 4, including 2 maximum with 360 Halo probe.
* Endoscopy is performed under general anesthesia.
* The removal must begin at the top 1cm above the upper pole of the lesion and must end 1cm below the lower pole of the lesion.
* The patient is left fasting until morning. In case of chest pain, the patient may receive analgesics.
* During the time of treatment, the patient must follow an antisecretory therapy pump inhibitor with dual proton dose orally. The patient should avoid taking aspirin or nonsteroidal anti-inflammatory drugs during the 10 days following each session.

Oesophagectomy

Radiofrequency ablation

First intent treatment for superficial circular esophageal neoplasm is surgical resection. Endoscopic mucosal resection is not recommended due to the high rate of subsequent esophageal stenosis (higher than 80%).

Surgical limits are related to a high level of morbidity due, in particular, to respiratory complications or infections that require prolonged hospitalisations, and by significant rate of mortality (from 2 to 5 %). As an alternative to the surgical treatment, an innovative technique to remove esophageal circular preneoplastic and neoplastic lesions has been developed: it consists to ablate the mucosa by means of a balloon of a fixed diameter which incorporates approximately 100 electrodes on its surface that emit radiofrequency waves (HALO® Radiofrequency Ablation Technology System). By varying the strength and the duration of the electrical impulses, it is possible to obtain a homogenous and controlled destruction of the tissue of the whole mucosa, leaving no remaining pre-neoplastic or neoplastic elements underneath. The technique will be used for high grade glandular epithelial neoplasia, Vienna 4-1 or 4-2, developed on a mucosa at risk, i.e. the Barrett's oesophagus, occupying more than half of the circumference of the esophagus and that requires surgical treatment. The expected benefit for the patient is linked to the reduced invasiveness of the technique in comparison to the surgery

Radiofrequency in the Treatment of Barrett's Oesophagus

Clinical and Medico-economic Evaluation of Radiofrequency Ablation Versus Oesophagectomy in the Treatment of High Grade Dysplasia in Barrett's Oesophagus

The rate of success of the technique, success being defined as the complete histological eradication of the high grade glandular epithelial neoplasia without death attributable to the procedure. The relation of a death to the procedure will be determined by a committee of experts consisting of 3 surgeons or 3 hepatogastroenterologists depending on the arm, who do not participate to the study.

Hospices Civils de Lyon

Symptoms and General Pathology

Adenocarcinoma

Postoperative Complications

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

A pre-operative personalised exercise programme (my-PEP).

A pre-operative personalised exercise programme (my-PEP) consisting of: 1) actions to promote exercise, using behavioural change techniques (BCTs), 2) home inspiratory muscle training (IMT), 3) a home exercise programme (HEP) - which is also current standard care, 4) a 4 week hospital-supervised aerobic and muscle strengthening programme (Hos-PEP) .

Pre-operative Exercise Programme (my-PEP)

Home Exercise Programme (HEP)

Professor Andrew Hart

Dr Stephen Lam

The purpose of this feasibility study is to determine whether a structured exercise programme prior to oesophagectomy has: acceptable adherence, is safe, and improves physiological measures of physical fitness above standard care.

The number of patients with oesophageal cancer is rising dramatically in the UK. Curative cancer surgery (oesophagectomy) is offered to around 40% of affected patients. However, oesophagectomy is a major operation with a high risk of complications. Around 1 in 3 patients will suffer such a complication after surgery, mostly due to heart or lung problems. Most complications are not due to the surgery itself, but related to the patient's physical fitness before their operation. Studies in other surgeries, but not oesophagectomy, have shown that complications may be reduced by improving a patient's physical fitness before their operation. The ExPO team has developed a pre-operative Personalised Exercise Programme (my-PEP), specifically for patients undergoing oesophagectomy. my-PEP has 4 main components: three are exercise modalities (aerobic exercise, breathing exercises and muscle strengthening); the fourth is where a participant's potential barriers to exercise are assessed and behavioural change techniques (BCTs) are suggested to improve exercise engagement in the trial. In total, 32 patients who are due to undergo oesophagectomy at the Norfolk and Norwich Hospital will be recruited and then randomly divided into 2 arms of 16 each. One arm will receive my-PEP in the standard 3-4 months prior to surgery, the other will receive standard care advice to exercise at home. The research objectives are to obtain feasibility data on whether my-PEP is acceptable, adhered to and safe, and whether it improves patient fitness above standard care. Follow up will be 90 days after surgery to obtain a preliminary imprecise estimate of whether my-PEP reduces complications. If the ExPO trial shows promise in these areas, this will inform and justify a future large multi-centre trial to definitively answer whether my-PEP can reduce complications after oesophagectomy. If so, my-PEP could potentially change and improve the pre-operative management of oesophageal cancer patients across the NHS.

Exercise Prior to Oesophagectomy

A Pre-operative Personalised Exercise Programme to Improve Physical Fitness and Reduce Post-operative Cardiopulmonary Complications After Oesophagectomy in Patients With Oesophageal Adenocarcinoma: A Feasibility Randomised Controlled Trial

The number of participants recruited from all eligible patients

Number of patients that drop-out from trial

Number of patients that decline to participate in the trial

Measured with International Physical Activity Questionnaire (IPAQ)

Measured with Determinates of Physical Activity Questionnaire (DPAQ)

Physical activity diary used to assess adherence

The number of adverse events during the trial assessed using CTCAE

Assessed with maximal cardiopulmonary exercise test on a bicycle ergometer

Assessed with mean inspiratory pressure testing in cmH20

Cardiopulmonary complication rates as per ECCG definition.

Inpatient, 30-day and 90-day non-cardiopulmonary complication rates as per ECCG definition.

University of East Anglia

Antineoplastic Agents

Fluorouracil

Cisplatin

Taxane

Patients who had chemoradiotherapy before surgery.

Patients who had chemotherapy before surgery.

Patients who only had oesophagectomy. Various surgical oesophagectomy methods were used, such as Ivor Lewis, transthoracic, three-hole, transhiatal, and left transthoracic. The appropriate surgical approach for each patient was chosen according to the tumour location, size, and depth.

In most patients, the chemotherapy regimens before surgery were consisted of cisplatin combined with either fluorouracil or taxanes.

Neoadjuvant chemoradiotherapy

Various surgical oesophagectomy methods were used, such as Ivor Lewis, transthoracic, three-hole, transhiatal, and left transthoracic,and the appropriate surgical approach for each patient was chosen according to the tumour location, size, and depth.

Neoadjuvant chemotherapy

Herui Yao, PhD

Haiyu Zhou, PhD

Michael Lanuti, PhD

To provide comprehensive efficacy and safety profiles of neoadjuvant chemoradiotherapy (NCRT) versus neoadjuvant chemotherapy (NCT) versus surgery alone in resectable oesophageal carcinoma.

Neoadjuvant chemotherapy (NCT) or neoadjuvant chemoradiotherapy (NCRT) has been shown to be better than surgery alone in patients with resectable oesophageal carcinoma, but higher quality evidence is needed as new findings have emerged regarding this issue.Previous evidence-based findings and the current guidelines have not established a survival advantage of NCRT over NCT or an acceptable safety profile of the addition of radiotherapy to NCT; whether NCRT or NCT is more effective for the treatment of adenocarcinoma or squamous cell carcinoma of the oesophagus is unclear.This study aims to provide comprehensive efficacy and safety profiles of NCRT versus NCT versus surgery alone in resectable oesophageal carcinoma.

Neoadjuvant Chemotherapy or Chemoradiotherapy in Resectable Oesophageal Carcinoma（NewEC Study）

Clinical Evidence for Association of Neoadjuvant Chemotherapy or Chemoradiotherapy With Efficacy and Safety in Patients With Resectable Esophageal Carcinoma (NewEC Study)

The datasets used or analysed during the current study are available from the corresponding author on reasonable request.

The OS was calculated as the time from the date of the histologically documented diagnosis to the date of death or the final follow-up.

DFS was calculated from the date of R0 resection to the date of disease recurrence or death from any cause

R0 resection was defined as gross disease removed with negative margins (tumour-free resection margin).

pCR was defined as no evidence of residual tumour cells in the primary site and resected lymph nodes of the operative specimens.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Radiofrequency in the Treatment of Barrett's Oesophagus	NCT02558504	Esophageal Neop...	Oesophagectomy Radiofrequency ...	18 Years -	Hospices Civils de Lyon
Radiofrequency in the Treatment of Barrett's Oesophagus	NCT02558504	Esophageal Neop...	Oesophagectomy Radiofrequency ...	18 Years -	Hospices Civils de Lyon
Exercise Prior to Oesophagectomy	NCT02962219	Postoperative C... Oesophageal Ade...	Pre-operative E... Home Exercise P...	18 Years -	University of East Anglia
Radiofrequency in the Treatment of Barrett's Oesophagus	NCT02558504	Esophageal Neop...	Oesophagectomy Radiofrequency ...	18 Years -	Hospices Civils de Lyon
Neoadjuvant Chemotherapy or Chemoradiotherapy in Resectable Oesophageal Carcinoma（NewEC Study）	NCT04027543	Radiotherapy Si... Chemotherapy Ef... Oesophageal Car... Effect of Drugs Safety Issues	Neoadjuvant che... Oesophagectomy Neoadjuvant che...	18 Years - 80 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Neoadjuvant Chemotherapy or Chemoradiotherapy in Resectable Oesophageal Carcinoma（NewEC Study）	NCT04027543	Radiotherapy Si... Chemotherapy Ef... Oesophageal Car... Effect of Drugs Safety Issues	Neoadjuvant che... Oesophagectomy Neoadjuvant che...	18 Years - 80 Years	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Spots Global Cancer Trial Database for oesophagectomy