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 Details — Status: Completed

Administrative data

• NCT number: NCT02965976
• Other study ID #: I 283516
• Secondary ID: NCI-2016-01568I
• Status: Completed
• Phase: Phase 2
• Start date: December 30, 2016
• Est. completion date: April 28, 2022

Study information

• Verified date: January 2023
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 28, 2022
• Est. primary completion date: January 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Carcinoma
• Esophageal Neoplasms

Intervention

Biological:
• Botulinum Toxin Type A
Given IM

Procedure:
• Esophagectomy
Undergo esophagectomy

Other:
• Quality-of-Life Assessment
Ancillary studies

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delayed Gastric Emptying Assessed Radiographically by Nuclear Medicine Emptying Study	Will be assessed using the intent-to-treat principle and a one-sided Cochran-Mantel-Haenszel (CMH) test.	Up to day 21
Secondary	Delayed Gastric Emptying Assessed Radiographically by Gastrografin Swallow OR CT Esophagram	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
Secondary	Gastrointestinal and Nutritional Status Including Days to Resumption of Oral Feeding as Assessed by Dietician	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
Secondary	Hospital Length of Stay Attributed to Delayed Gastric Emptying	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	Secondary Procedure Due to Delayed Gastric Emptying	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
Secondary	Pulmonary Events Directly Related to Delayed Gastric Emptying as Assessed by Operating Surgeon	The rate of post-operative pulmonary events will be compared between treatment arms using the two-sided CMH exact test.	Up to day 90
Secondary	Quality of Life Score as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 OES18	Will be compared between treatment arms using the two sided independent-sample, stratified T-test.	Up to day 90