Digestive System Diseases

All Conditions

Neoplasms

Symptoms and General Pathology

Rare Diseases

Gastroesophageal Reflux

Esophageal Neoplasms

Constriction, Pathologic

Esophageal Stenosis

Esophageal Cancer

Central Nervous System Depressants

All Drugs and Chemicals

Reproductive Control Agents

Anesthetics

Ulipristal acetate

Placement of a gastroesophageal stent with anti-migration device : Ella®, Leufen, Novatech

Placement of a gastroesophageal stent without anti-migration device : Hanarostent® ECW, Life Partners Europe

A gastroesophageal stent is placed during a digestive endoscopy performed under general anesthesia, under endoscopic and fluoroscopic control

Gastroesophageal stent placement

David KARSENTI, MD

Maira MORENO, PHD

The aim of this prospective, controlled, randomized, multicentre, single-blind study is to compare the rate of intragastric migration of 2 types of esophageal stents with and without an anti-migration device placed for locally advanced or metastatic malignant stenosis of the gastroesophageal junction.

In order to reduce the rate of spontaneous intragastric migration of esophageal stent placed for gastroesophageal junction tumor, anti-migration device has been developed. Pilot studies suggest the absence of morbidity of this device, but no comparative study has been conducted to confirm the interest of this anti-migration device.

The aim of this study is to compare the rate of intragastric migration of 2 types of esophageal stents with and without an anti-migration device placed for locally advanced or metastatic malignant stenosis of the gastroesophageal junction.

* Main objective: To evaluate the rate of intragastric migration of 2 types of esophageal stents (one with and the second without anti-migration device) placed for malignant stenosis of the gastroesophageal junction.
* Secondary objective(s):

  * Degraded migration rate (M3 and M6) if patient alive, and duration of survival without dysphagia
  * Comparison of the morbidity of these two stents
  * Comparison of the effectiveness of these two stents on dysphagia and reflux
  * Clinical and technical failure rate of these two stents

This is a prospective, controlled, randomized, multicentre, single-blind study.

This is a prospective, controlled, randomized, multicentre, single-blind study.

The stent is placed under endoscopy during general anesthesia. The type of stent is not specified in the endoscopy report. The patient is not informed of the type of esophageal stent placed.

Anti-Migration System for Anti-reflux Oeso-gastric Stent (ANTIMIG)

Esophageal Stent With or Without Anti-migration Device for Tumors of the Gastroesophageal Junction: Multicenter Randomized Controlled Study. ANTIMIG Study

Stent Intragastric migration rate at M1 confirmed on radiography or CT

Stent Intragastric migration rate at M3 confirmed on radiography or CT

Stent Intragastric migration rate at M6 confirmed on radiography or CT

Dysphagia evaluation in 5 stages (Atkinson score) at M1 0 - no dysphagia

1. - Clinging to the swallowing of solids
2. - Semi-liquid feeding possible
3. - Liquid feeding possible
4. - Aphagia (need for parenteral nutrition)

Dysphagia evaluation in 5 stages (Atkinson score) at M3 0 - no dysphagia

1. - Clinging to the swallowing of solids
2. - Semi-liquid feeding possible
3. - Liquid feeding possible
4. - Aphagia (need for parenteral nutrition)

Dysphagia evaluation in 5 stages (Atkinson score) at M6 0 - no dysphagia

1. - Clinging to the swallowing of solids
2. - Semi-liquid feeding possible
3. - Liquid feeding possible
4. - Aphagia (need for parenteral nutrition)

Dysphagia-free survival time at the end of the study

Technical success rate of stent placement under digestive endoscopy defined by good progression of contrast through the stent into the gastric cavity after stent placement

Medical success rate of stent placement under digestive endoscopy on dysphagia (dysphagia resorption after endoscopy)

Gastroesophageal reflux disease with the Reflux Disease Questionnaire (RDQ) score. The Reflux Disease Questionnaire a 12-item self-administered questionnaire, was designed to assess the frequency and severity of heartburn, regurgitation, and dyspeptic complaints and to facilitate the diagnosis of GERD. Minimum 12 : better outcome Maximum 72 : worse outcome

Necessity of blood transfusion and/or endoscopic management

Need for opioid treatment for more than 48 hours after stent placement or removal of the stent because of pain

Pneumoperitoneum diagnosed by CT in case of abnormal pain within hours of stent placement

Société Française d'Endoscopie Digestive

Principal Investigator

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available

Partially covered SEMS

Fully covered SEMS

Marco J Bruno, M.D., Prof

The purpose of this study is to determine whether fully covered or partially covered metal stents are more favorable in incurable malignant stenosis of the esophagus or cardia. Primary outcome will be the occurence of recurrent dysphagia which is defined as dysphagia due to a stent or tumour related cause in a 6-month follow-up

Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures

A Randomized Comparison of a Fully Covered Self Expandable Metal Stent Versus a Partially Covered Self Expandable Metal Stent in Malignant Esophageal Strictures

This is defined as occurrence of dysphagia due to a stent or tumor related cause. These include tumor in- or overgrowth, stent migration, stent fracture or food impaction.

Technical succes was defined as succesful deployment of the stent which bridges the stricture

Clinical success was defined as an improvement of dysphagia (at least 1 point reduction in the Dysphagia score) during follow-up.

Dysphagia scores will be obtained at time point: t=0, t= 1 week, t=2 weeks, t=1 month, t=3 months and t= 6 months

A major adverse event was defined as a life-threatening event, including perforation, major haemorrhage, severe pain (NRS pain score ≥ 7), pneumonia, stridor and fistula.

Survival from stent placement until death or placement of second stent

Foundation for Liver Research

M.D., PhD

One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.

Partially covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available

Insertion of a Partially Covered SEMS

Fully covered SEMS: Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available

Insertion of a Fully Covered SEMS

Total

Age, Continuous

Sex: Female, Male

Dysphagia was scored according to the internationally used scoring system: score 0, able to consume a normal diet; score 1, dysphagia with certain solid foods; score 2, able to swallow semi-solid soft foods; score 3, able to swallow liquids only; score 4, complete dysphagia.

Range 0-4, a higher score represents a worse outcome

Dysphagia score

World Health Organization Performance Score

0 Able to carry out all normal activity without restrictions.

1. Restricted in physically strenuous activity but ambulatory and able to carry out light work.
2. Ambulatory and capable of all self-care but unable to carry out any work; up and more than 50% of waking hours.
3. Capable of only limited self-care; confined to bed or chair more than 50% of waking hours.
4. Completely disabled; cannot carry on any self-care; totally confined to bed or chair.

Range 0-4, a higher score respresents a worse outcome

Etiology/histology stricture

Presence of distant metastasis

Previous chemotherapy

Previous radiotherapy

Location stricture

Length of tumor

Length of stricture

Dr. V.M.C.W. Spaander

Number of Participants With Recurrent Dysphagia.

Number of Participants With Technical Success of SEMS Placement

Number of Participants With Clinical Success Defined as Improvement of Dysphagia Score

Number of Participants in Whom a Major Complication Has Occured

Median Survival After SEMS Placement

Overall Study

Wounds and Injuries

Fistula

Esophageal Fistula

Esophageal Perforation

Pathological Conditions, Anatomical

Digestive System Fistula

Placement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal

Evolution® Esophageal Stent - Fully Covered

John Vargo, M.D., M.P.H.

The CLARITY study is a clinical trial approved by US FDA to study the removal of the Evolution® Esophageal Stent-Fully Covered in malignant and benign indications.

Removal of the Evolution® Esophageal Stent - Fully Covered

Clinical Investigation to Evaluate Removal of the Evolution® Esophageal Stent - Fully Covered

The study design allowed for 130 patients to be enrolled to ensure that 58 patients had an attempted endoscopic stent removal between 7 days and 6 months in order to assess the primary measure as per sample size calculation. Therefore, the first 58 patients (malignant or benign lesions) with data submitted regarding attempted endoscopic stent removal are included in this outcome measure. Successful stent removal is one in which the study stent is completely removed from the patient during a single endoscopic procedure with the wire mesh integrity maintained such that the stent can be removed in one contiguous piece. Additionally, successful stent removal includes no tissue damage or hemorrhage visible during the retrieval procedure that is both related to the endoscopic stent removal and requires immediate treatment.

The rate of clinical success in patients with strictures that showed improvement or relief of dysphagia symptoms or a seal sufficient to enable oral intake in patients with fistulas, perforations, or leaks.

Cook Group Incorporated

Evolution® Esophageal Stent - Fully Covered: Placement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal

Evolution® Esophageal Stent

Ethnicity

Race/Ethnicity, Customized

Alan Saunders, MDR, RAC; Manager, Biostatistics

Number of Patients With Successful Removal of Study Stent

Evolution® Esophageal Stent - Fully Covered: Placement of the Evolution® Esophageal Stent for benign fistulas, perforations or leaks with the intention of removal

Number of Patients With Benign Indications That Achieved Clinical Success

Ear, Nose, and Throat Diseases

Mouth and Tooth Diseases

Dilatation, Pathologic

Deglutition Disorders

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Antineoplastic Agents

Anti-Infective Agents

Mitomycins

Mitomycin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Alkylating Agents

Enzyme Inhibitors

Endoscopy injection of Mitomycin C will be perform to the treatment of pharyngoesophageal stenosis refractory to endoscopic treatment with dilatation in patients with head and neck cancer

administration included dilation of the stenotic segment with thermoplastic bougies, followed by the injection of 3mg of Mitomycin C, divided into 4 aliquots of 0.75mg, injected in the four quadrants, at the stenosis level.

Endoscopic injection of Mitomycin C

Management of pharyngoesophageal stenosis (PES) in patients after head and neck cancer (HNC) treatment remains a challenge. There are some cases of strictures refractory to dilation sessions. This study aimed to evaluate the efficacy of Mitomycin C (MMC) endoscopic injection for the treatment of refractory pharyngoesophageal stenosis.

Patients and methods: This is a prospective study in patients with dysphagia following head and neck cancer treatment, without evidence suggestive of tumor recurrence, and refractory to endoscopic treatment. Theses undergo endoscopic dilation of the stenotic segment with thermoplastic bougies, followed by the injection of MMC.

Management of pharyngoesophageal stenosis (PES) after cancer treatment in patients with head and neck cancer (HNC) remains a challenge. The etiology of PES in this group of patients is probably multifactorial, being associated with surgical manipulation, ischemic effects of radiotherapy and even cancer recurrence. It is estimated that up to 50% of patients treated for advanced HNC will present some degree of dysphagia. PES is a frequent cause of post treatment dysphagia of HNC patients. Although the exact prevalence is unknown, several retrospective series estimate that upper cervical stricture is present in 1% to 23% of the cases. The initial approach to PES is endoscopic dilation with a reported success rate ranging from 76% to 96%. In patients with refractory strictures to dilation sessions, endoscopic corticosteroid injection, such as triamcinolone, is usually added to the dilation sessions, which may increase the success of the endoscopic treatment. A relatively small group of patients will be refractory to the association of dilation and corticosteroid injection treatment. Metal stents may be considered in this scenario, but in the case of pharyngoesophageal stenosis, this approach is limited by cervical pain and foreign body sensation. Surgical reconstruction for pharyngoesophageal stenosis refractory to endoscopic treatment is the last therapeutic option (2). Previous radiotherapy, eventual reconstruction with cutaneous flaps make a surgical manipulation of the cervical region a real challenge, with increased adverse event rate, including restenosis.(2) Because of such difficulties, this prospective study aimed to evaluate the efficacy of Mitomycin C (MMC) endoscopic injection for the treatment of pharyngoesophageal stenoses in patients who were treated for head and neck cancer, refractory to endoscopic dilation treatment. There are descriptions of the use of Mitomycin C for scar prevention after ophthalmologic and otorhinolaryngological interventions (8). Its use in endoscopy has previously been described for the treatment of laryngeal and tracheal stenosis as well as refractory esophageal stenosis. Mitomycin C is a substance isolated from the bacterium Streptomyces caespitosus, which is used as a chemotherapeutic agent and has antiproliferative effects on fibroblasts, reducing fibroblast proliferation and collagen formation. Some studies demonstrated the ability to decrease fibroblast activity and consequent scar formation after the application of Mitomycin C on culture of fibroblasts in low concentrations (0.1 to 0.4 mg / ml) for 5 to 10 minutes, affecting their proliferation for over 3 weeks.

Endoscopic Injection of Mitomycin C for the Treatment of Pharyngoesophageal Stenosis

Endoscopic Injection of Mitomycin C for the Treatment of Pharyngoesophageal Stenosis Refractory to Endoscopic Treatment With Dilatation in Patients With Head and Neck Cancer

dysphagia score (0 = able to eat normal diet / no dysphagia;1 = able to swallow some solid foods; 2 = able to swallow only semi solid foods; 3 = able to swallow liquids only; 4 = unable to swallow anything / total dysphagia)

decrease in the number of sessions of endoscopic dilations

Fauze Maluf Filho

Adenocarcinoma

Barrett Esophagus

Precancerous Conditions

Anti-Inflammatory Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Prednisolone

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Daily prednisolone is taken for 6 weeks, at a dose of 40mg in week 1, 30mg in week 2, 20mg week 3 and 4, 10mg in week 5, and 5mg in week 6. Prednisolone is taken in the morning. Treatment commences the day of the procedure, with the dose taken with a sip of water prior to discharge. The 6-week treatment regimen is given after both the 1st and 2nd stage CBE.

Daily placebo is taken for 6 weeks, at a dose of 40mg in week 1, 30mg in week 2, 20mg week 3 and 4, 10mg in week 5, and 5mg in week 6. Placebo is taken in the morning. Treatment commences the day of the procedure, with the dose taken with a sip of water prior to discharge. The 6-week treatment regimen is given after both the 1st and 2nd stage CBE.

Daily placebo is taken for 6 weeks, at a dose of 40mg in week 1, 30mg in week 2, 20mg week 3 and 4, 10mg in week 5, and 5mg in week 6. Placebo is taken in the morning. Treatment commences the day of the procedure, with the dose taken with a sip of water prior to discharge. The 6-week treatment regimen is given after both the 1st and 2nd stage CBE

Placebo Oral Tablet

Michael Bourke

Barretts mucosa is a premalignant condition of the oesophagus, which can progress to cancer. Oesophageal cancer is aggressive, with a 5 year survival of only \~15%. High risk Barretts mucosa, containing high grade dysplasia or early cancer, can be removed by endoscopic mucosal resection (EMR) during gastroscopy. If patients can be effectively treated by EMR while they have premalignant or early malignant disease, it is a curative procedure.

Currently, the major limitation of Complete Barretts Excision (CBE) by EMR, is scar tissue development in the oesophagus, leading to stricture formation and difficulty swallowing (dysphagia). If a safe and effective method could be found to reduce this risk, the treatment options for early oesophageal cancer would be greatly improved. CBE is performed as a two stage procedure, with 2 gastroscopies 8 weeks apart. In this randomised, doubleblind study, eligible and enrolled patients are randomised after the 1st stage CBE to receive either prednisolone tablets or placebo. Inclusion criteria are patients with short segment (\<3cm circumferential disease) Barretts oesophagus with high grade dysplasia or early cancer. The treatment period is for 6 weeks after both CBE sessions. Prednisolone is given in a reducing dose over the 6 weeks, starting at 40mg daily.

The primary outcome is symptomatic dysphagia development. Endoscopic dilation will be performed as required for dysphagia secondary to symptomatic oesophageal stricture formation persisting for ≥2 days, or complete dysphagia for any time period. Endoscopic surveillance with biopsies will occur at a 3 month, 6 month then 12 month interval following CBE, to assess for complete removal of Barretts mucosa.

Following two stage CBE, stricture rates without preemptive therapy in noncircumferential, circumferential \<2cm, and circumferential \<3cm disease, are estimated to be 30%, 50% and 70% respectively. The investigators predict a 50% reduction in stricture rate with oral steroid therapy. With a primary analyses of oral steroid versus placebo tested at a 5% level of significance in a two tailed test, 58 patients are needed per group. Allowing for a 5% drop out rate, a total of 126 patients are required. The study will be performed at five Australian Tertiary Hospitals, and the recruitment period is estimated to be 2 years.

Barretts oEsophageal Resection With Steroid Therapy Trial

Reduction in Symptomatic Oesophageal Stricture Formation Post-two Stage Complete Barrett's Excision for High Grade Dysplasia or Early Adenocarcinoma With Short-term Steroid Therapy: A Randomized, Doubleblind, Placebo-controlled, Multicentre Trial.

The direct medical costs and indirect non-medical costs of production lost will be calculated based on Australian Medical guidelines, and compared between each treatment strategy.

Rate of symptomatic oesophageal stricture formation.A symptomatic stricture is defined as a stricture leading to the inability to tolerate a soft diet for ≥ 2 days, or the presence of complete dysphagia for any length of time.

The need for, and number of endoscopic dilations.

Dysphagia score (DS) at 3, 6 and 12 month surveillance endoscopies. DS: 0 = Normal diet; 1 = Some solid foods; 2 = Semi-solid foods; 3 = Liquids only; 4 = Total dysphagia

Endoscopic evidence of stricture formation at 3, 6 and 12 month surveillance endoscopies. No stricture, mild stricture, moderate stricture ('hugs' the gastroscope but the gastroscope can pass), severe stricture (cannot be passed with the gastroscope)

Recurrence of Barretts mucosa, defined as the presence of Barretts mucosa endoscopically, or mucosal columnar epithelium with or without intestinal metaplasia on surveillance biopsies. Measured at 3-month surveillance (20 weeks post 1st CBE), 6 month surveillance (46 weeks post 1st CBE), and 12 month surveillance (98 weeks post 1st CBE) endoscopies.

Professor Michael Bourke

Professor

Infections

Blood and Lymph Conditions

Immune System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Tuberculosis

Sarcoidosis

Bronchial Neoplasms

Tracheal Stenosis

Tracheal Diseases

Respiratory Tract Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Bronchial Diseases

truFreeze Spray Cryotherapy administered as routine clinical care

truFreeze Spray Cryotherapy

Nicholas Shaheen, MD

Robert F Browning, MD

To collect efficacy and outcomes data related to the use of trūFreeze® spray cryotherapy for the treatment of unwanted tissue in the pulmonary and gastrointestinal settings.

This is a prospective, multi-center registry of patients who are currently undergoing spray cryotherapy using the trūFreeze® device. The registry population consists of patients who are being treated using the spray cryotherapy trūFreeze® device for the removal of unwanted tissue, such as malignant or pre-malignant conditions in the pulmonary or gastrointestinal settings.

Patients eligible to participate in the registry will have disease and treatment specific data collected throughout therapy and long-term follow-up. Subjects will be considered to have completed the registry when data from the 5 year follow-up visit has been collected. The beginning of the follow-up period commences with the first endoscopic treatment session.

Subjects may be withdrawn prior to this for any of the following reasons:

1. Death, or
2. Lost to Follow-Up, or
3. Withdrawal of consent, or
4. Discontinuation by the investigator. Three attempts at contact using two different methods are required prior to determination that the subject is lost to follow-up. Attempts at contact must be with certified letters OR documented telephone contact.

The registry will utilize electronic case report forms using a web-based platform housed at the University of North Carolina at Chapel Hill. Access to the database will be limited to individuals involved in the research registry and will require a unique user ID and password. All access to the database and web-based application will be encrypted (HTTPS) and electronic systems compliant with applicable privacy and security regulations. To maintain patient confidentiality, all subjects will be assigned a registry identification number, and this will be the only link between subject identity and treatment information. Read-only access will be provided to any personnel who is not an administrator or responsible for data entry.

All data requested on the case report form must be recorded. All missing data must be explained. The system allows sites to directly enter data electronically, however sites are still responsible for ensuring they have source documents that support all data entered electronically that are separate and verifiable. The registry system will maintain an audit trail that captures when electronic entries are changed, what the change was, and who made the change.

The investigators will ensure the capability for inspections of applicable registry-related facilities (e.g. pharmacy, diagnostic laboratory, etc.). The registry will be monitored by the sponsor, and allow auditing by the Institutional Review Board, government regulatory bodies, and University compliance and quality assurance groups of all registry related documents (e.g. source documents, regulatory documents, data collection instruments, registry data, etc.).

trūFreeze® Spray Cryotherapy Patient Registry

The registry population consists of patients who are being treated using the trūFreeze® spray cryotherapy device for the removal of unwanted tissue, such as malignant or pre-malignant conditions in the pulmonary or gastrointestinal settings.

All adverse events occurring during the registry period must be recorded. The clinical course of each event should be followed until resolution, stabilization, or until it has been determined that the registry treatment or participation is not the cause. Serious adverse events that are still ongoing at the end of the Spray Cryotherapy Patient Registry registry period must be followed up to determine the final outcome. Any serious adverse event that occurs after the registry period and is considered to be possibly related to the trūFreeze® spray cryotherapy device or registry participation should be recorded and reported immediately.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Anti-Migration System for Anti-reflux Oeso-gastric Stent (ANTIMIG)	NCT05431738	Stent Migration GastroEsophagea...	Gastroesophagea...	18 Years - 91 Years	Société Française d'Endoscopie Digestive
Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures	NCT01661686	Esophageal Canc... Esophageal Sten...	Partially cover... Fully covered S...	18 Years -	Foundation for Liver Research
Removal of the Evolution® Esophageal Stent - Fully Covered	NCT01900691	Esophageal Fist... Esophageal Neop... Esophageal Perf... Esophageal Sten... Stents	Evolution® Esop...	18 Years -	Cook Group Incorporated
Endoscopic Injection of Mitomycin C for the Treatment of Pharyngoesophageal Stenosis	NCT03540953	Esophageal Sten... Deglutition Dis... Head and Neck N... Esophageal Neop...	Endoscopic inje...	18 Years -	Instituto do Cancer do Estado de São Paulo
Barretts oEsophageal Resection With Steroid Therapy Trial	NCT02004782	Barrett Esophag... Esophageal Sten...	Prednisolone Placebo Oral Ta...	18 Years - 90 Years	Western Sydney Local Health District
Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures	NCT01661686	Esophageal Canc... Esophageal Sten...	Partially cover... Fully covered S...	18 Years -	Foundation for Liver Research
Anti-Migration System for Anti-reflux Oeso-gastric Stent (ANTIMIG)	NCT05431738	Stent Migration GastroEsophagea...	Gastroesophagea...	18 Years - 91 Years	Société Française d'Endoscopie Digestive
trūFreeze® Spray Cryotherapy Patient Registry	NCT01802203	Barrett Esophag... Esophageal Dysp... Esophageal Neop... Esophageal Sten... Bronchial Neopl... Stenosis of Bro...	truFreeze Spray...	18 Years -	US Endoscopy Group Inc.

Spots Global Cancer Trial Database for esophageal stenosis