Neoplasms

All Conditions

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Patients with non-lifting adenomas, adnomas at difficult anaotomic locations , T1-carcinomas or submucosal colorectal tumors

Endoscopic full thickness resection (EFTR)

Arthur R Schmidt, MD

Karel Caca, MD, PhD

Arthur Schmidt, MD

Karel Caca, Prof.

Arthur R Schmidt, Dr.

Observational prospective multicenter study to investigate efficacy and safety of endoscopic full thickness resection in the lower GI tract using a novel over-the-scope full thickness resection device.

The FTRD ("Full Thickness Resection Device", Ovesco Endoscopy, Tübingen, Germany) is an over the scope device consisting of a transparent cap with a preloaded monofilament snare and and a 14 mm modified Over-the-scope Clip. The device is CE marked for full thickness resection in the lower GI tract.

The study was designed to investigate efficacy and safety of this device for full thickness resection of colorectal lesions.

Endoscopic Full Thickness Resection in the Lower GI Tract With the "Full Thickness Resection Device"

Endoscopic Full Thickness Resection in the Lower GI Tract With the "Full Thickness Resection Device"- A Prospective Multicenter Trial

Successful enbloc- and macroscopically complete resection

Histologically confirmed complete resection

Histologically confirmed full thickness resection

Procedure-associated complications such as bleeding or perforation

Ovesco Endoscopy AG

Kliniken Ludwigsburg-Bietigheim gGmbH

Digestive System Diseases

Symptoms and General Pathology

Nervous System Diseases

Rare Diseases

Gastrointestinal Diseases

Gastroesophageal Reflux

Fistula

Gastroparesis

Esophageal Achalasia

Gastric Outlet Obstruction

Pyloric Stenosis

Constriction, Pathologic

Pathological Conditions, Anatomical

Stomach Diseases

Paralysis

Neurologic Manifestations

Idiopathic Achalasia

Cardiospasm

These procedures include: POEM (Peroral Endoscopic Myotomy) for Achalasia, G-POEM (Gastric Peroral Endoscopic Myotomy) for gastric outlet obstruction, Z-POEM (Peroral endoscopic myotomy for Zenker's Diverticulum), EMR (Endoscopic Mucosal Resection), ESD (Endoscopic submucosal dissection), STER (Submucosal tunneling endoscopic resection), NOTES (Natural Orifice Translumenal Endoscopic Surgery), TIF (Transoral Incisionless Fundoplication), Endoscopic Fistula Closure, Endoscopic Suturing, Capsule Endoscopy and EFTR (Endoscopic full-thickness resection).

Endoscopic Surgery

Michel Kahaleh, MD

Currently, there is limited multi-center data on endoscopic surgery outcomes in western populations.

Evaluation of these measurement would help the investigators compare them to conventional treatment modalities within current tertiary facilities; and consequently help the investigators identify appropriate treatment techniques and improve clinical management of patients at Rutgers RWJMS.

The purpose of this retrospective registry study is to assess long term data on efficacy, safety and clinical outcome of Endoscopic Surgery within the gastrointestinal tract.

Our tertiary-care institution performs clinically-indicated various Endoscopic Surgery procedures gastrointestinal indications in more than 800-1000 patients annually.

The study investigators would collect data on a large sample size of subjects undergoing various endoscopic resection procedures such as POEM (Peroral Endoscopic Myotomy), EMR (Endoscopic Mucosal Resection), ESD (Endoscopic submucosal dissection), STER (Submucosal tunneling endoscopic resection), NOTES (Natural Orifice Translumenal Endoscopic Surgery), TIF (Transoral Incisionless Fundoplication), Endoscopic Fistula Closure, Endoscopic Suturing, Capsule Endoscopy and EFTR (Endoscopic full-thickness resection). Clinical metrics will be collected including procedure times, length of follow-up, specific tumor characteristics, resection method, pathology results, procedural complications, additional therapy required, and disease-free survival time.

Various endoscopic surgical procedures are less invasive than traditional surgery, have fewer side effects and provide better efficacy. Moreover, they can be available to patients who are ineligible for surgery or who have refused more aggressive surgical intervention.

They improve quality of life and extend survival duration.

Endoscopic surgery procedures can be an appropriate approach in many gastrointestinal disorders including early neoplasms, challenging adenomas or sub-epithelial lesions that requires the resection of the superficial layers, mucosa and submucosa, or full thickness resection of the tract wall.

Currently, there is limited multi-center data on endoscopic surgery outcomes in western populations.

Evaluation of these measurement would help the investigators compare them to conventional treatment modalities within current tertiary facilities; and consequently help the investigators identify appropriate treatment techniques and improve clinical management of patients at Rutgers RWJMS.

The purpose of this retrospective registry study is to assess long term data on efficacy, safety and clinical outcome of Endoscopic Surgery within the gastrointestinal tract.

Endoscopic Surgery for Gastrointestinal Disorders: A Multicenter Registry Study

Data will not be shared with other researchers.

Type, frequency and intensity of adverse events

Chart Review of quality-of-life improvement and overall survival duration

Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University

Stomach Neoplasms

Colonic Neoplasms

Esophageal Neoplasms

Gastrointestinal Neoplasms

Colonic Polyps

Duodenal Neoplasms

Polyps

Digestive System Neoplasms

Head and Neck Neoplasms

Esophageal Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Duodenal Diseases

Stomach Cancer

Esophageal Cancer

Any Endoscopic resection for Gastrointestinal disorders including neoplasms.

Endoscopic Resection

Monica R Gaidhane, MPH

This is a retrospective and prospective multicenter registry to collect long-term data (1 year) on patients who have or will undergo Endoscopic resection such as EMR, ESD, EFTR, STER, etc. within the gastrointestinal tract for endoscopic treatment of early gastrointestinal neoplasms involving the resection of the superficial layers, mucosa and submucosa, of the tract wall.

Subjects will be consented for medical chart review.

The purpose of this retrospective and prospective registry is to assess long term data on efficacy, safety and clinical outcome of Endoscopic Resection within the gastrointestinal tract (1 year).

The registry will evaluate efficacy, technical feasibility, clinical outcome, safety profile and overall clinical management through medical chart review. The procedures the investigators are evaluating are all clinically indicated and will not be prescribed to someone to participate in this registry study.

Endoscopic resection can be an appropriate approach in early neoplasms, challenging adenomas or sub-epithelial lesions. Endoscopic resection can be considered as a less invasive approach than surgery. Moreover, endoscopic resection can be available to patients who are ineligible for surgery or who have refused more aggressive surgical intervention.

The study investigators would collect data on a large sample size of subjects undergoing various endoscopic resection procedures such as EMR (Endoscopic Mucosal Resection), ESD (Endoscopic submucosal dissection), STER (Submucosal tunneling endoscopic resection, and EFTR (Endoscopic full-thickness resection). Clinical metrics will be recorded including procedure times, length of follow-up, specific tumor characteristics, resection method, pathology results, procedural complications, additional therapy required, and disease-free survival time.

Currently, there is limited multi-center data on endoscopic resection outcomes in western populations.

Evaluation of these measurement would help the investigators compare them to conventional treatment modalities within current tertiary facilities; and consequently help the investigators identify appropriate treatment techniques and improve clinical management of patients at WCMC-NYPH.

The purpose of this retrospective and prospective registry is to assess long term data on efficacy, safety and clinical outcome of Endoscopic Resection within the gastrointestinal tract (1 year).

Endoscopic Resection Multicenter Registry

Endoscopic Resection: A Retrospective and Prospective Multicenter Registry

Number of participants with successful completion of treatment

To assess resolution of symptoms of all Endoscopic resection procedures at 6 months

Number of subjects with Adverse Events; Type, frequency and intensity of adverse events within 30 days of procedure

Weill Medical College of Cornell University

Chief of Endoscopy

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

The steps of EFTR are as follows. Initially, the lesion will be marked circumferentially using the FTRD probe available with the device (Forced Coag, E1, 20W). Subsequently, wire guided balloon dilatation of the pyloric channel will be performed. The device will be mounted over a therapeutic channel gastroscope and negotiated across the cricopharynx over the guidewire with or without assistance of dilating balloon available with the device. After reaching the target site, the lesion will be pulled withing the FTRD cap with the help of grasping forceps and gentle suctioning. The clip will be fired after ensuring the entry of the lesion inside the cap, the premounted snare closed and electrocautery activated to cut the grasped tissue (HighCut 200W, Effect 4).

ESD will be performed using the standard technique under general anaesthesia. The steps of the procedure are as follows: a) marking of the lesion using closed tip of DualKnife J in soft coagulation mode (Effect 4, 80W), b) submucosal lifting injection using saline mixed with indigocarmine dye, c) circumferential mucosal incision (Dry Cut, Effect 2, 30W), d) submucosal dissection (SwiftCoag, Effect 2, 30W), removal of the lesion using suction or a polypectomy snare, f) closure of the defect using endoclips or loop and endoclips.

Endoscopic resection is recommended for the management of small DNETs measuring ≤10 mm. Various endoscopic techniques have been utilized for the resection of DNETs including endoscopic mucosal resection (EMR), band ligation assisted EMR, endoscopic submucosal dissection (ESD). However, the published studies report a high rate of histologically incomplete resection even with ESD. More recently, device assisted endoscopic full thickness resection (EFTR) has emerged as a safe and effective resection modality in cases with upper and lower gastrointestinal (GI) mucosal as well as submucosal lesions. There is limited data on the outcomes of EFTR in cases with DNETs.

Endoscopic submucosal dissection

Initially, the lesion will be marked circumferentially using the FTRD probe available with the device (Forced Coag, E1, 20W). Subsequently, wire guided balloon dilatation of the pyloric channel will be performed.

The device will be mounted over a therapeutic channel gastroscope and negotiated across the cricopharynx over the guidewire with or without assistance of dilating balloon available with the device.

After reaching the target site, the lesion will be pulled withing the FTRD cap with the help of grasping forceps and gentle suctioning.

The clip will be fired after ensuring the entry of the lesion inside the cap, the premounted snare closed and electrocautery activated to cut the grasped tissue (HighCut 200W, Effect 4).

EFTR

Zaheer Dr Nabi, MBBS MD DNB

Ayush Dr Singh, MBBS MD

Zaheer Dr Nabi, MBBS MD

Introduction :

The incidence of duodenal neuroendocrine tumors (DNETs) is increasing. Endoscopic resection is recommended for the management of small DNETs measuring ≤10 mm. Various endoscopic techniques have been utilized for the resection of DNETs including endoscopic mucosal resection (EMR), band ligation assisted EMR, endoscopic submucosal dissection (ESD). However, the published studies report a high rate of histologically incomplete resection even with ESD. More recently, device assisted endoscopic full thickness resection (EFTR) has emerged as a safe and effective resection modality in cases with upper and lower gastrointestinal (GI) mucosal as well as submucosal lesions. There is limited data on the outcomes of EFTR in cases with DNETs.

In this study, we aim to compare the rate of histologically complete resection (R0) with ESD and EFTR in cases with DNETs.

Primary objective:

Rate of R0 resection in both the groups

Secondary outcomes:

1. Technical success: defined as en-bloc resection of the lesion without any residual lesion endoscopically
2. Procedure duration
3. Adverse Events

Inclusion criteria:

1. Adult patients (≥18 years) with biopsy proven duodenal neuroendocrine tumors (DNETs)
2. Size of the lesion \<15 mm
3. Absence of local and distant metastases (EUS and DOTANOC scan)
4. Willing to provide informed consent

Exclusion criteria:

1. Large lesions \>15 mm
2. Invasion of muscularis layer and beyond on imaging (EUS)
3. Scarring or deformity in duodenum
4. Active duodenal ulcer
5. History of prior resection
6. Coagulopathy

Device Assisted Full Thickness Resection Versus Endoscopic Submucosal Dissection for Duodenal Neuroendocrine Tumors

Endoscopically and pathologically complete resection

Time to complete each procedure in minutes

Adverse events during and after the procedure

Asian Institute of Gastroenterology, India

STUDY DIRECTOR

EFTR with the FTRD developed for gastric resection (gFTRD).

Benjamin Meier

Karel Caca

Subepithelial gastric tumors are rare and usually detected incidentally. Most subepithelial tumors (SET) are benign but up to 13% of all lesions can be malignant. Histology after needle biopsy often brings no clear diagnosis in SET, so further strategy often remains unclear. Surveillance endoscopy can be associated with the risk of progression. Endoscopic resection usually is difficult, associated with high risk of complications and sometimes is not feasible. Surgical resection is also associated with a risk of complications and often refused by the patients. With the developement of the gFTRD-System gastric SET can now be resected endoscopically. The advantage of this technique is the complete resection and a full-thickness resections specimen for are definite histology.

Endoscopic Full-thickness Resection of Gastric Subepithelial Tumors With the gFTRD

Residual or recurrent adenoma/carcinoma at endoscopic follow up

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Endoscopic Full Thickness Resection in the Lower GI Tract With the "Full Thickness Resection Device"	NCT02362126	Colorectal Aden... Submucosal Tumo...	Endoscopic full...	18 Years -	Kliniken Ludwigsburg-Bietigheim gGmbH
Endoscopic Surgery for Gastrointestinal Disorders: A Multicenter Registry Study	NCT05041608	Achalasia Gastric Outlet ... Gastroparesis GERD Reflux Fistula Benign Neoplasm	Endoscopic Surg...	-	Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
Endoscopic Resection Multicenter Registry	NCT03065257	Gastrointestina... Gastrointestina... Gastric Cancer Gastric Neoplas... Gastric Polyp Esophageal Neop... Duodenal Neopla... Duodenal Polyp Stomach Neoplas... Stomach Polyp Neoplasms Colon Polyp Colon Neoplasm	Endoscopic Rese...	18 Years -	Weill Medical College of Cornell University
Device Assisted Full Thickness Resection Versus Endoscopic Submucosal Dissection for Duodenal Neuroendocrine Tumors	NCT06121752	Neuroendocrine ...	Endoscopic subm... EFTR	18 Years - 80 Years	Asian Institute of Gastroenterology, India
Endoscopic Full Thickness Resection in the Lower GI Tract With the "Full Thickness Resection Device"	NCT02362126	Colorectal Aden... Submucosal Tumo...	Endoscopic full...	18 Years -	Kliniken Ludwigsburg-Bietigheim gGmbH
Endoscopic Full-thickness Resection of Gastric Subepithelial Tumors With the gFTRD	NCT03096236	Feasibility, Co...	EFTR	18 Years - 99 Years	Kliniken Ludwigsburg-Bietigheim gGmbH
Endoscopic Full-thickness Resection of Gastric Subepithelial Tumors With the gFTRD	NCT03096236	Feasibility, Co...	EFTR	18 Years - 99 Years	Kliniken Ludwigsburg-Bietigheim gGmbH

Spots Global Cancer Trial Database for eftr

Every month we try and update this database with for eftr cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for eftr

Every month we try and update this database with for eftr cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for eftr cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.