- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02965976
Botulinum Toxin Type A in Preventing Complications After Surgery in Patients With Esophageal Cancer
Double-Arm, Randomized Study of Botulinum Toxin Injection as a Pyloric Drainage Procedure for Minimally Invasive Esophagectomy (Phase II)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Esophageal carcinoma, undergoing minimally invasive esophagectomy with intrathoracic anastomosis
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
- Patients who have a history of gastrointestinal dysmotility or functional gastroparesis, including diabetic gastroparesis, central and peripheral nervous system disorders, renal failure, medication side effects, including chronic dependence of promotility agents, anticholinergic antispasmodic agents, or chronic narcotic use over 2 years due to non-cancer causes
- Patients who have a history of previous gastric or duodenal surgery
- Patients who have a history of duodenal ulcer or duodenal fibrosis
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Allergy to botulinum toxin and/or egg
- Pregnant or nursing female participants
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigator's opinion deems the participant an unsuitable candidate for study participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I (botulinum toxin type A, esophagectomy)
Patients receive botulinum toxin type A injection IM while undergoing standard minimally invasive esophagectomy.
|
Ancillary studies
Other Names:
Undergo esophagectomy
Other Names:
Given IM
Other Names:
|
Active Comparator: Arm II (esophagectomy)
Patients undergo standard minimally invasive esophagectomy.
|
Ancillary studies
Other Names:
Undergo esophagectomy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Delayed Gastric Emptying Assessed Radiographically by Nuclear Medicine Emptying Study
Time Frame: Up to day 21
|
Will be assessed using the intent-to-treat principle and a one-sided Cochran-Mantel-Haenszel (CMH) test.
|
Up to day 21
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Delayed Gastric Emptying Assessed Radiographically by Gastrografin Swallow OR CT Esophagram
Time Frame: At day 7
|
Delayed gastric emptying assessed Radiographically by Gastrografin Swallow OR CT Esophagram at day 7. Will be compared between treatment arms using the two-sided CMH exact test.
|
At day 7
|
Gastrointestinal and Nutritional Status Including Days to Resumption of Oral Feeding as Assessed by Dietician
Time Frame: Up to day 35
|
The days to resumption of oral feeding are calculated based on return to a solid diet.
Will be compared between treatment arms using the two sided independent-sample, stratified T-test.
|
Up to day 35
|
Hospital Length of Stay Attributed to Delayed Gastric Emptying
Time Frame: Up to 90 days
|
The total length of stay is calculated as the difference between the date of procedure and date of discharge.
Will be compared between treatment arms using the two sided independent-sample, stratified T-test.
|
Up to 90 days
|
Secondary Procedure Due to Delayed Gastric Emptying
Time Frame: Up to 90 days
|
The rate of secondary procedures (within 90 days) will be compared between treatment arms using a one-sided CMH exact test.
|
Up to 90 days
|
Pulmonary Events Directly Related to Delayed Gastric Emptying as Assessed by Operating Surgeon
Time Frame: Up to day 90
|
The rate of post-operative pulmonary events will be compared between treatment arms using the two-sided CMH exact test.
|
Up to day 90
|
Quality of Life Score as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 OES18
Time Frame: Up to day 90
|
Will be compared between treatment arms using the two sided independent-sample, stratified T-test.
|
Up to day 90
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Moshim Kukar, Roswell Park Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Esophageal Neoplasms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins
- Botulinum Toxins, Type A
- abobotulinumtoxinA
- incobotulinumtoxinA
Other Study ID Numbers
- I 283516 (Other Identifier: Roswell Park Cancer Institute)
- NCI-2016-01568 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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