Esophageal Neoplasms Clinical Trial
Official title:
Comparison of Ivor Lewis and Tri-incision Approaches in Performing Minimally
Esophagectomy for esophageal cancer is a technically complex procedure which is associated with high perioperative mortality, even in high volume centers[1]. To facilitate the postoperative recovery of esophagectomies patients by reducing surgical trauma, an increasing number of surgeons have attempted minimally invasive esophagectomy (MIE) to treat patients with esophageal cancer.[2-10] However, there is no consensus regarding the optimal method for performing an esophagectomy with the minimally invasive surgical technique. In addition, the benefit of this approach has not been well confirmed based on the limited retrospective comparative studies at the present time [3, 11-12], although its potential benefit improving the immediate postoperative including the total morbidity and pulmonary complication has been demonstrated by meta-analyses[13]. Especially it is unclear whether adding laparoscopic procedures in MIE can contribute to further improvement of the perioperative outcome of the patients.[3] Previously, the investigators have found that adding of laparoscopic procedure in performing the esophageal reconstruction procedure after VATS esophagectomy can provide further benefit in reducing the postoperative major complications and fasten the postoperative recovery16. For the most cases, the patients was receiving tri-incision esophagectomy, i.e. VATS esophagectomy in the chest, laparoscopic gastric mobilization in the abdomen and left cervical esophagogastrostomy. In such circumstances, a cervical incision was required for esophagogastrostomy after esophagectomy and gastric mobilization. However, for the patients with lower-to mid third esophageal cancer, some surgeon performed Ivor Lewis esophagectomy, which performing the esophagogastrostomy in the chest after gastric mobilization without cervical incision wound. Although both of these procedures have been demonstrated to be feasible and safe, there is much debate about the advantage and disadvantage of these two approaches. For tri-incision esophagectomy, patients have the chance to have cervical lymph node dissection and the esophagus can be resected up to the neck. However, it is more time-consuming and associated with more surgical trauma by adding a cervical incisional wound and more tissue dissection around the cervical trachea as compared to that done by Ivor Lewis esophagectomy. In contrast, for the Ivor Lewis esophagectomy, the resection of esophagus was limited to the level of thoracic inlet and cervical lymph node dissection was impossible unless a neck incision was further created. However, it takes less time in performing the whole procedure by saving a neck incision.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 2015 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Patients with a diagnosis of esophageal cancer - Age: below 75 years old. - Tumor location: 2 cm above GEJ and 5 cm below thoracic inlet. - Tumor stage: less than TNM stage III Exclusion Criteria: - Poor lung function with FEV1 less than 70% of prediction. - Major systemic co-morbidity : e.g. CVA, end-stage renal disease, coronary artery disease, congestive heart failure. - Presence of tracheal invasion or distant metastasis of the tumor |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival duration | 2 years | Yes | |
Secondary | Surgical complication | 2 years | Yes | |
Secondary | Postoperative ICU stay and hospital stay | 1 month | Yes | |
Secondary | Quality of Life | 2 years | Yes | |
Secondary | Change of lung function after surgery | 2 years | Yes |
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 |