Clinical trial · Interventional
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)
NCT02965976CI-TRIAL-00063993completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Carcinoma | Esophageal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Botulinum Toxin Type A | Biological | — | UNRESOLVED |
| Esophagectomy | Procedure | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (botulinum toxin type A, esophagectomy)
- description
- Patients receive botulinum toxin type A injection IM while undergoing standard minimally invasive esophagectomy.
- interventionNames
- Biological: Botulinum Toxin Type A
- Procedure: Esophagectomy
- Other: Quality-of-Life Assessment
- type
- ACTIVE_COMPARATOR
- label
- Arm II (esophagectomy)
- description
- Patients undergo standard minimally invasive esophagectomy.
- interventionNames
- Procedure: Esophagectomy
- Other: Quality-of-Life Assessment
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.