Recruiting

Nutritional Support

Sponsor:

Mehdi Qiabi

Code:

NCT05314946

Conditions

Esophageal Cancer

Nutrition Aspect of Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

No feeding tube placed

Placement of a percutaneous feeding tube

Study Details

Brief summary:

Patients diagnosed with esophageal cancer have difficulty eating, as the food pipe becomes obstructed by the cancer. This may impair the ability for the patient to receive appropriate calorie intake, especially during administration of chemotherapy and radiation therapy given prior to surgical resection.

A strategy is to place a feeding tube directly in the stomach or in the small bowel to have an access to the patient's gastrointestinal tract during administration of chemo radiation therapy. However, these feeding tubes may lead to adverse events, including dislodgement, infection, the tube may be plugged, etc. If these complications were to happen, patients may have their treatment delayed, may have to come to the emergency department or even be admitted. In some cases, patients may need to have a surgery performed to treat the complication. Most centres in Canada have moved away from placement of these feeding tubes due to the high incidence of complications associated with the feeding tubes placement, and due to the high efficacy from the chemoradiation therapy in shrinking the tumour, allowing for the patient to swallow.

In London, the preference from the Medical and Radiation Oncologists was to have these feeding tubes placed to avoid delay in treating the patients. There is therefore significant controversy as to what is the best approach in this patient population. Our goal is to run a feasibility randomized controlled trial studying this question.

Conditions

Esophageal Cancer

Nutrition Aspect of Cancer

Study ID

NCT05314946

Start date

Nov 1, 2022

Status verified date

Apr, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Sep 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult patient
  • Non-cervical biopsy-proven esophageal or gastroesophageal junction (Siewert I or II) cancer
  • Patient eligible for induction therapy then esophagectomy (stage Ib to III)

Exclusion Criteria:

  • Impossibility to pass an endoscope beyond the tumour
  • metastatic disease
  • early-stage disease with either upfront esophagectomy or endoscopic resection planned
  • patient refusal of the feeding tube
  • inability to swallow their pill
  • inability to tolerate a full fluid diet

Study Design

Enrollment

26 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Percutaneous enteral access

Feeding tube, either gastrostomy (G-) tube or gastrojejunostomy (GJ-) tube (placed by Interventional Radiology) or J-tube (surgically placed)

experimental: No percutaneous enteral access

No feeding tube placed.

Interventions

No feeding tube placed

The experimental arm will forego placement of a feeding tube.

Placement of a percutaneous feeding tube

The standard arm will have a feeding tube placed (G-tube or GJ-tube by IR; or surgically placed J-tube)

Primary outcome measure

  • Feasibility of the trial [ Time Frame: From randomization to 90-day post-operative ]

Central Contacts and Locations

Central contacts

Locations

London Health Sciences Centre - Victoria Hospital

Recruiting

London, Ontario, Canada, N6A 5W9

Principal Investigator:

Mehdi Qiabi, MD MSc

More Information

Sponsor

Mehdi Qiabi

Last update posted

Apr 3, 2024

Last verified

Apr, 2024

Keywords

  • cancer
  • esophagus
  • enteral nutrition
  • feeding tube
  • adverse events
  • randomized controlled trial
  • feasibility

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mehdi Qiabi on 2024-04-03.