Clinical Trials Logo
  1. Home
  2. Esophageal Neoplasms
  3. NCT04780256
  4. Details
NCT04780256 Clinical Trial

Endoscopic Resection of Gastrointestinal Neoplasms

Esophageal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04780256
Other study ID # CORE 3
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 15, 2021
Est. completion date December 2022

Study information
Verified date July 2021
Source Arcispedale Santa Maria Nuova-IRCCS
Contact Paolo Cecinato, MD
Phone +393476117414
Email paolo.cecinato@ausl.re.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - 18 years or older - all patients who have undergone endoscopic resection of an upper or lower digestive tract tumor Exclusion Criteria: - age under 18 - inability to provide informed consent

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Italy IRCCS-AUSL Reggio Emilia Reggio Emilia RE

Sponsors (1)
Lead Sponsor Collaborator
Arcispedale Santa Maria Nuova-IRCCS

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary en bloc resection rate the en bloc resection is the ability to remove the neoplasia in a single piece one month
Primary complete resection rate the complete resection is the ability to remove the neoplasia with clear margins (R0) one month
Primary recurrence rate recurrence is the recurrence of the neoplasm at the resection site during follow-up one year
Secondary adverse events rate complication rate, early or late, related to the procedure used for endoscopic resection one month
Secondary costs evaluation of the costs incurred to perform the endoscopic resection one month
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05013697 - TQB2450 Solution for Injection (TQB2450)+Paclitaxel+Cisplatin ± Anlotinib in the Treatment of Esophageal Cancer. Phase 2
Completed NCT02128243 - Trial of S-1 Maintenance Therapy in Metastatic Esophagogastric Cancer Phase 2
Completed NCT02253602 - Innovative MRI Techniques to Improve Treatment Stratification of Patients With Esophageal Cancer N/A
Completed NCT01900691 - Removal of the Evolution® Esophageal Stent - Fully Covered N/A
Completed NCT01719926 - Phase I Platinum Based Chemotherapy Plus Indomethacin Phase 1
Terminated NCT01572987 - Endoscopic Resection or Ablation for Patients With Dysplasia or Cancer Requiring Treatment of Barrett's Esophagus N/A
Terminated NCT00760604 - A Phase III Study of En Bloc Versus Non-En Bloc Esophagectomy in Esophageal Cancer Phase 3
Completed NCT00160030 - Study Comparing Radiochemotherapy With Folfox 4 Regimen or 5FU-Cisplatin in Patients With Inoperable Esophageal Cancer Phase 2
Suspended NCT00048529 - Study of T900607-Sodium in Subjects With Previously Treated Gastric Cancer or Adenocarcinoma of the Esophagus Phase 2
Recruiting NCT05007106 - MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005) Phase 2
Completed NCT02284802 - Early Detection of Tumors of the Digestive Tract by Confocal Endomicroscopy N/A
Terminated NCT03223662 - Metabolomic and BH3 Profiling of Esophageal Cancers: Identification of Novel Assessment Methods of Treatment Response for Precision Therapy Phase 2
Completed NCT05680077 - KCNA3 and OTOP2 Gene Methylation Combined Detection Kit (Fluorescent PCR Method)
Completed NCT03549494 - Evaluation of Ocoxin®-Viusid® in Advanced Stomach Cancer and Gastric Esophagogastric Junction Phase 2
Completed NCT03261947 - A Study to Evaluate the Safety, Tolerability, and Activity of TAK-931 in Participants With Metastatic Pancreatic Cancer, Metastatic Colorectal Cancer, and Other Advanced Solid Tumors Phase 2
Terminated NCT00094978 - Depsipeptide/Flavopiridol Infusion for Cancers of the Lungs, Esophagus, Pleura, Thymus or Mediastinum Phase 1
Recruiting NCT02908204 - Long-term Outcomes of Superficial Esophageal Squamous Cell Carcinoma N/A
Completed NCT02378948 - Nutritional Route In Esophageal Resection Trial II N/A
Completed NCT02703142 - Endoscopic Evaluation After Esophagectomy N/A
Recruiting NCT02604615 - The Role of Different Cycles of Chemotherapy（Capecitabine-oxaliplatin） in Esophageal Chemoradiotherapy Phase 3