Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Participants undergo upper GI endoscopy with endoscopic mucosal resection (EMR) and/or radiofrequency ablation (RFA) of esophageal squamous dysplasia (ESD). After initial therapy participants undergo repeat endoscopy every 3 months for a year, with re-biopsy and re-treatment of residual ESD as appropriate.

Endoscopic Mucosal Resection (EMR)

Endoscopic radiofrequency ablation of regions of ESD

Radiofrequency ablation

Stephen L Burgert, MD

Esophageal cancer is common in Kenya. The precursor of esophageal cancer is esophageal squamous dysplasia (ESD). In this study, persons known to have ESD will undergo endoscopic removal or ablation of ESD in order to prevent development of esophageal cancer.

Esophageal squamous dysplasia (ESD) is the precursor lesion of esophageal squamous cell cancer. ESD causes no symptoms but can be detected by screening. ESD may harbor various grades of dysplasia. Patients with moderate grade or high grade dysplasia (MGD or HGD) have up to a 40-fold increased risk of esophageal squamous cell cancer.

In this study, persons known to have ESD with MGD or HGD on the basis of prior screening will be invited to undergo endoscopic treatment with either endoscopic mucosal resection (EMR) and/or radio frequency ablation (RFA) in order to remove or ablate regions of ESD. Participants will undergo a series of endoscopies to treat ESD and monitor success of treatment.

Endoscopic Prevention of Esophageal Cancer at Tenwek Hospital

Endoscopic Prevention of Esophageal Cancer at Tenwek Hospital (The EXPECT Trial) by Removal or Ablation of Esophageal Squamous Cell Dysplasia

The percentage of subjects demonstrating complete response defined as complete histological clearance of MGD, HGD and esophageal squamous carcinoma in the treatment areas at 12 months after the initial ablation procedure.

Percentage of participants experiencing serious adverse events following EMR or RFA treatment.

Mayo Clinic

National Cancer Institute (NCI)

Medtronic - MITG

Tenwek Hospital

Director of Endoscopy Services

Symptoms and General Pathology

Adenoma

Colonic Polyps

Polyps

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pathological Conditions, Anatomical

Intestinal Polyps

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Pharmaceutical Solutions

All Drugs and Chemicals

Vasoconstrictor Agents

Respiratory System Agents

Herbal and Botanical

Epinephrine

Racepinephrine

Epinephryl borate

Cola

Piecemeal EMR is a conventional endoscopic resection technique. A submucosal injection of a large volume of a solution (normal saline or other) with or without dilute epinephrine (1/10,000) with or without indigo carmine is performed. Then, sequential piecemeal resection is performed with use of a combination of stiff-type snares. At the end of the procedure when macroscopically visible adenoma has been totally resected, a snare tip soft coagulation (STSC) of the margin of the scar is performed to eliminate non visible residual neoplastic tissue. This procedure is quicker and safer than ESD but led to more recurrent disease (around 20% with the standard technique but recently reduced to 5% after the introduction of STSC)

ESD is a newer resection technique that allows en bloc resection for large LSLs. A submucosal injection is also needed but, in this case, different endo-knives are used to achieve the resection instead of diathermic snares. The en bloc resection allows a more precise pathological analysis and the risk of recurrence is lower (\<2%) when margins are tumor-free.

Endoscopic mucosal resection (EMR) is an endoscopic resection technique that allows the removal of large colorectal lesions using a conventional "lift-and-cut" procedure or an underwater technique

Endoscopic mucosal resection (EMR)

Endoscopic submucosal dissection (ESD) is an endoscopic procedure that allows dissection of larger colorectal lesions in one piece using endoknives.

The procedure is technically more difficult, much more time-consuming than EMR, mandates multiday hospital admission and has an increased risk of perforation.

Endoscopic submucosal dissection (ESD)

José C. Marín-Gabriel, Assoc. Prof.

Esperanza Ulloa-Márquez

José C. Marín-Gabriel

Alberto Herreros de Tejada

Eduardo Albéniz-Arbizu

Álvaro Terán-Lantarón

Pedro J. Rosón-Rodríguez

Joaquín Rodríguez-Sánchez

Hugo Uchima-Koecklin

Gloria Fernández-Esparrach

Adolfo Parra-Blanco

David Martínez-Ares

EMR and ESD are both effective and safe and are associated with a very low risk of procedure related mortality when performed for colorectal laterally spreading lesions (LSL).

Some kind of LSLs have a low risk of submucosal invasive carcinoma (SMIC) or these foci are found in well demarcated areas of the tumor. This is the case of the non-granular flat elevated (LSN-NG-FE) and the LSLs-G mixed subtypes.

The investigators aim to assess if piecemeal EMR (the older technique) for LSLs-G mixed type \> 30 mm and LSLs-NG FE type \> 20 mm is not inferior to ESD (the new treatment) for the need of additional surgery in the mid-term.

Endoscopic submucosal dissection (ESD) is curative for lesions with superficial submucosal invasive carcinoma (s-SMIC) and favourable histological features. The procedure is performed mainly for laterally spreading lesions (LSLs) and is the reference treatment for these neoplasms in Asian countries nowadays. LSLs can be granular (G) or non-granular (NG). Most LSLs-G homogenous type are superficial and can be resected by EMR because SMIC is often lacking. On the other hand, since LSLs-G mixed type \> 20 - 30 mm have a higher prevalence of SMIC when compared with the homogenous subtype, Asian experts now recommend ESD for this kind of tumors. However, some years ago, EMR had been suggested for LSLs-G mixed type if the largest nodule was resected first and the histological assessment was done separately. The rationale for the latter approach is that the invasive component is usually found within the large nodule.

Conversely, the prevalence of SMIC is higher in LSLs-NG PD type, therefore, ESD is the preferred therapeutic intervention. In addition, LSLs-NG FE type have been associated with multifocal invasion in Japanese studies. However, in Western countries, the percentage of SMIC in LSLs-NG FE type \> 20 mm seems much lower than previously described in Asian series. Thus, the investigators do not know if EMR might be enough to remove these tumours.

Furthermore, if the risk of s-SMIC is low, the recurrence rates for ESD in these kind of lesions (LSL-G mixed type \> 30 mm and LSL-NG FE type \> 20 mm) might be comparable to that of piecemeal EMR, in terms of curative resection (avoiding the need for surgery) in the mid-term. When performing an EMR, recurrences are more frequent, but they are largely inconsequential because it is usually unifocal, diminutive and easily can be managed endoscopically on subsequent sessions.

In order to clarify the controversial issue of performing colorectal ESD in Western countries, the investigators aim to assess if piecemeal EMR (the older technique) for LSLs-G mixed type \> 30 mm and LSLs-NG FE type \> 20 mm is not inferior to ESD (the new treatment) for the need of additional surgery in the mid-term.

Endoscopic Mucosal Resection Versus Endoscopic Submucosal Dissection for Colorectal Laterally Spreading Lesions.

Endoscopic Mucosal Resection Versus Endoscopic Submucosal Dissection for Laterally Spreading Lesions Non Granular-Flat Elevated Type (LSL-NG-FE) ≥ 20 mm and LSLs-Granular Mixed Type ≥ 30 mm. A Randomized, Non-inferiority Trial.

Spanish Society of Digestive Endoscopy

José Carlos Marín Gabriel

Principal Investigator

Stomach Neoplasms

Colonic Neoplasms

Duodenal Neoplasms

Stomach Diseases

Duodenal Diseases

Stomach Cancer

The endoscopic resection is the procedure that allows to remove cancerous or precancerous conditions of digestive tract. Endoscopic resection can be preformed by several techniques:

1. Endoscopic mucosal resection (EMR): it allows to remove mucosal lesions
2. Endoscopic submucosal dissection: it allows to remove mucosal lesions that involved submucosal layer and large lesions
3. Full-thickness resection: it allows to remove infiltrating lesions by the resection of a little piece of the entire gastrointestinal wall

Endoscopic resection

Paolo Cecinato, MD

Matteo Lucarini, MD

The study aims to retrospectively investigate the endoscopic resection procedures of cancerous and precancerous lesions of the upper and lower digestive tract in order to evaluate the efficacy and safety outcomes and to compare different resection techniques. In particular, the resection techniques investigated will be mucosectomy, en bloc and piecemeal, endoscopic submucosal dissection (ESD) and its variants, full-thickness resection. The anatomical districts involved will be the esophagus, stomach, duodenum, colon and rectum.

Endoscopic Resection of Gastrointestinal Neoplasms

Retrospective Study of Efficacy and Safety of the Endoscopic Removal of Cancerous and Precancerous Lesions of the Upper and Lower Digestive Tract

the en bloc resection is the ability to remove the neoplasia in a single piece

the complete resection is the ability to remove the neoplasia with clear margins (R0)

recurrence is the recurrence of the neoplasm at the resection site during follow-up

complication rate, early or late, related to the procedure used for endoscopic resection

evaluation of the costs incurred to perform the endoscopic resection

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Endoscopic Prevention of Esophageal Cancer at Tenwek Hospital	NCT02146508	Esophageal Canc... Esophageal Squa...	Endoscopic Muco... Radiofrequency ...	18 Years - 85 Years	Tenwek Hospital
Endoscopic Prevention of Esophageal Cancer at Tenwek Hospital	NCT02146508	Esophageal Canc... Esophageal Squa...	Endoscopic Muco... Radiofrequency ...	18 Years - 85 Years	Tenwek Hospital
Endoscopic Mucosal Resection Versus Endoscopic Submucosal Dissection for Colorectal Laterally Spreading Lesions.	NCT04593407	Neoplasms, Colo...	Endoscopic muco... Endoscopic subm...	18 Years - 85 Years	Hospital Universitario 12 de Octubre
Endoscopic Resection of Gastrointestinal Neoplasms	NCT04780256	Endoscopic Muco... Endoscopic Subm... Gastric Neoplas... Colonic Neoplas... Esophageal Neop... Duodenal Neopla...	Endoscopic rese...	18 Years - 100 Years	Arcispedale Santa Maria Nuova-IRCCS

Spots Global Cancer Trial Database for endoscopic mucosal resection (emr)