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Completed

NCT Number: NCT02965976

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

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.

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Key information

Conditions

Esophageal Carcinoma Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum toxin type A

Biological

Given IM

Other names: AbobotulinumtoxinA, Botox, Botox Cosmetic, Botulinum A Toxin, Botulinum Neurotoxin Type A, Botulinum Toxin A, BTX-A, Dysport, EvabotulinumtoxinA, IncobotulinumtoxinA, OnabotulinumtoxinA, Onaclostox, Xeomin

Esophagectomy

Procedure

Undergo esophagectomy

Other names: excision of the esophagus

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Nov 17, 2016
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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