Esophageal Neoplasms Clinical Trial
Official title:
Endoscopic - Vacuum Assisted Closure of Intrathoracic Postsurgical Leaks
The purpose of this study is to determine the short and long term outcome of endoscopic vacuum assisted closure of intrathoracic postsurgical leaks.
Intrathoracic leakage is a serious complication after esophageal surgery. The reported
incidence of esophageal anastomotic leaks after gastrectomy and esophagectomy ranges from 5%
to almost 30%. Within the last 10 years endoscopic treatment has changed the approach to
intrathoracic anastomotic leakages. Application of metal clips, injection of fibrin glue and
placement of self expanding metal or plastic stents (SEMS/SEPS) have been reported to
successfully achieve closure of postoperative anastomotic leaks in approximately 66-100%.
Alternative endoscopically treatment modalities are welcome especially in cases of failure
of the above mentioned endoscopic treatment modalities to prevent the necessity of surgical
reintervention which is associated with high mortality or mutilating surgical outcome such
as proximal diversion with cervical esophagostomy.
Vacuum-assisted closure (V.A.C.) is an established treatment modality for extensive
cutaneous infected wounds. The V.A.C. system device is based on a negative pressure applied
to the wound via a vacuum sealed sponge tissue. The sponge results in formation of
granulation tissue, while the vacuum removes wound secretions and reduces edema and
therefore improves blood flow, all together achieving consecutive wound closure. Since its
introduction in the late 1990´s the number of indications for the V.A.C. system has steadily
increased. Recently the endoluminal application of a vacuum assisted wound closure system
for the closure of rectal anastomotic fistulas has been reported. Our group reported the
successful closure of intrathoracic anastomotic leaks in two cases by endoscopic placement
of a vacuum assisted closure system. Here we plan to study the efficacy, safety and long
term outcome of E-V.A.C. to treat major intrathoracic postsurgical leaks.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| 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 |
NCT02253602 -
Innovative MRI Techniques to Improve Treatment Stratification of Patients With Esophageal Cancer
|
N/A | |
| Completed |
NCT02128243 -
Trial of S-1 Maintenance Therapy in Metastatic Esophagogastric Cancer
|
Phase 2 | |
| 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 |
NCT02703142 -
Endoscopic Evaluation After Esophagectomy
|
N/A | |
| Completed |
NCT02378948 -
Nutritional Route In Esophageal Resection Trial II
|
N/A | |
| Recruiting |
NCT02604615 -
The Role of Different Cycles of Chemotherapy（Capecitabine-oxaliplatin） in Esophageal Chemoradiotherapy
|
Phase 3 |