Clinical Trials Logo
  1. Home
  2. Esophageal Carcinoma
  3. NCT02965976

Botulinum Toxin Type A in Preventing Complications After Surgery in Patients With Esophageal Cancer

Esophageal Carcinoma Clinical Trial

Official title:
Double-Arm, Randomized Study of Botulinum Toxin Injection as a Pyloric Drainage Procedure for Minimally Invasive Esophagectomy (Phase II)

Clinical Trial Summary

This randomized phase II trial studies how well botulinum toxin type A works in preventing complication after surgery in patients with esophageal cancer. Botulinum toxin type A may cause less complications of nausea and vomiting after surgery.

Clinical Trial Description

PRIMARY OBJECTIVES: I. Determine if intra-pyloric botulinum toxin type A (botulinum toxin) injection (Botox) during a minimally invasive esophagectomy decreases postoperative occurrence of delayed gastric emptying. SECONDARY OBJECTIVES: I. Determine if intra-pyloric botulinum toxin injection during a minimally invasive esophagectomy reduces the number of repeat procedures for delayed gastric emptying within 90 days. II. Determine if intra-pyloric botulinum toxin injection during a minimally invasive esophagectomy decreases time to oral intake meeting 100% of nutritional requirements. III. Determine if intra-pyloric botulinum toxin injection during a minimally invasive esophagectomy reduces the incidence of pulmonary complications directly related to delayed gastric emptying. IV. Determine if intra-pyloric botulinum toxin injection during a minimally invasive esophagectomy reduces hospital length of stay related to delayed gastric emptying. V. Determine if intra-pyloric botulinum toxin injection during a minimally invasive esophagectomy increases patient quality of life. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive botulinum toxin type A injection intramuscularly (IM) while undergoing standard minimally invasive esophagectomy. ARM II: Patients undergo standard minimally invasive esophagectomy. After completion of study treatment, patients are followed up at 2, 3-4, and 6-8 weeks, and at 90 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02965976
Study type Interventional
Source Roswell Park Cancer Institute
Contact
Status Completed
Phase Phase 2
Start date December 30, 2016
Completion date April 28, 2022
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05059444 - ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Not yet recruiting NCT05996484 - Neoadjuvant Therapy of Anlotinib Combined With Toripalimab and Chemotherapy for Resectable Esophageal Carcinoma Phase 2
Recruiting NCT02355249 - Traditional Three Incisions vs Minimally Invasive Thoracol-laparoscopic Esophagectomy for Esophageal Cancer Phase 3
Completed NCT01691625 - Concurrent Chemoradiation With or Without DC-CIK Immunotherapy in Treating Locally Advanced Esophageal Cancer N/A
Not yet recruiting NCT05937438 - Postoperative Radiotherapy Followed by Immunotherapy for Locally Advanced Esophageal Carcinoma Phase 1/Phase 2
Recruiting NCT05777707 - Neoadjuvant Therapy of PD-1 Blockade Combined With Chemotherapy for Esophageal Carcinoma Phase 1/Phase 2
Recruiting NCT02527057 - Diffusion-weighted Magnetic Resonance Imaging (DW-MRI )for Early Response Assessment in Patients With Esophageal Cancer N/A
Withdrawn NCT00636298 - Study of Cetuximab and Bevacizumab in Cancer of the Esophagus After Failure of Patient's First Therapy Phase 2
Recruiting NCT06009705 - Toripalimab Combined With Radiotherapy and S-1 for Older Patients With Esophageal Cancer
Recruiting NCT04652180 - Robot-assisted Thoracic Approach Versus Open Transthoracic Esophagectomy . N/A
Recruiting NCT04147494 - Experimental PET Imaging Scans Before Cancer Surgery to Study the Amount of PET Tracer Accumulated in Normal and Cancer Tissues Early Phase 1
Withdrawn NCT03220009 - Nivolumab or Expectant Observation Following Ipilimumab, Nivolumab, and Surgery in Treating Patients With High Risk Localized, Locoregionally Advanced, or Recurrent Mucosal Melanoma Phase 2
Recruiting NCT06199895 - Clinical Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Patients With Taxans-resistant Pancreatic Adenocarcinoma, Cholangiocarcinoma, Lung Cancer, Gastric Cancer, Esophageal Carcinoma, or Breast Cancer Phase 2
Completed NCT00590031 - Phase II Trial of Preoperative Combined Modality Therapy for Esophageal Carcinoma: Cisplatin-Irinotecan Followed by Radiation Therapy With Concurrent Cisplatin and Irinotecan. Phase 2
Active, not recruiting NCT00176800 - Chemoradiation and Tetrathiomolybdate (TM) in Patients With Esophageal Carcinoma Phase 2
Completed NCT03099382 - Study of SHR-1210 Versus Investigator's Choice of Chemotherapy for Participants With Advanced Esophageal Cancer Phase 3
Active, not recruiting NCT04607590 - Yoga Program for Improving the Quality of Life in Couples Coping With Cancer
Recruiting NCT00991094 - Data Collection for the Assessment of Acute and Late Normal Tissue in Patients Treated With Proton Therapy
Completed NCT01855854 - Second-line Treatment With Icotinib in Esophageal Carcinoma Patients With EGFR Overexpression (IHC 3+) or Positive FISH Phase 2
Recruiting NCT06265285 - Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program Phase 2