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Quality of Life and Dysphagia Following Palliative Stenting in Esophageal Cancer (CT0023)

18 Years
Open (Enrolling)
Esophageal Cancer

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Trial Information

Quality of Life and Dysphagia Following Palliative Stenting in Esophageal Cancer (CT0023)

Esophageal cancer is one of the 10 most frequent cancers in the world. The incidence of
esophageal cancer is rapidly increasing and is doing so at a more rapid rate than any other
cancer in the western world. The annual incidence reported in western countries is 3 per
100,000. In central China it has been reported to be as high as 140 per 100,000 in Linxian
Province in central China.

Esophageal cancer remains one of the most lethal of all malignancies. Once a diagnosis is
established, the prognosis is poor, with a 5-year survival rate of less than 10%. Despite
advances in therapy, more than 50% of patients have incurable disease at the time of
presentation and only one third of patients with localized disease experience long term

By the appearance of dysphagia and by the time of diagnosis, most patients are not
candidates for esophagectomy because symptoms are not present until at least 50% of the
circumference of the oesophagus is involved. Distant metastasis will usually be established
by this time.

The symptoms of dysphagia and weight loss that are commonly experienced have a significant
impact on quality of life for these patients. This makes palliative endoluminal stenting an
attractive option. The mainstay of treatment is the palliation of dysphagia resulting from
malignant stenosis and intraluminal tumor growth.

A number of palliative therapies are available to the treating physician. The options for
treating dysphagia that is caused by advanced, unresectable esophageal cancer include:
stenting, photodynamic therapy (PDT), thermal laser ablation, external beam radiation and

Brachytherapy offers safe palliation for malignant dysphagia over a relatively long period.
The results of brachytherapy are comparable to the other palliative methods. Increased
effectiveness and more symptomatic improvements have been reported with the combination of
external beam radiation with high dose brachytherapy. The combination was well tolerated and
relatively safe. Despite relatively safe, perforation and stricture formation are
complications for brachytherapy with or without external beam radiation. Furthermore,
brachytherapy has fallen out of favour in most centers due to the time to amelioration of
symptoms and the required multiple hospital visits for repeated procedures.

Photodynamic therapy (PDT) utilizes a photosensitizing agent, light and oxygen to
endoscopically ablate cancer cells. PDT has been suggested and evaluated for the treatment
of high grade esophageal dysplasia and intramucosal adenocarcinoma arising within Barrett's
oesophagus. Ablation with PDT has been effective for end stage esophageal cancer palliation
and improving malignant dysphagia. Esophagitis, photoreactions, perforation, and strictures
requiring dilatation are still the main complications for PDT and have been the reason for
its disappearance from clinical practise.

Laser and thermal ablation are commonly used methods for esophageal cancer palliation.
Despite relatively good results, perforation, and the necessity for re-intervention are the
main concern that limit their use for most end stage esophageal cancer patients.

Intra luminal esophageal stenting is widely used as an effective method for esophageal
cancer palliation. Esophageal stent insertion proved to be an effective method for
palliation of malignant dysphagia. It is a relatively safe procedure with a low rate of
serious complications. In a report of 127 stent placements in 100 patients, immediate relief
of dysphagia was observed with the stent insertion in 85% of patients. Adding to its proven
efficacy for treatment of dysphagia, stenting was proven to offer palliation with longer
interventional free periods than any other methods of palliation. Over the past decade,
advances in expandable stent technology have led to smaller, more flexible delivery systems
that are easier to manipulate than the original plastic stents. These attributes permit
successful deployment without exposing patients to the risks of aggressive mechanical

Stent insertion is also the only effective method for palliation of esophageal cancer with
extrinsic compression (metastatic mediastinal lymph nodes) causing dysphagia. Stenting also
plays an important role in treatment of patients with airway - esophageal fistulas.

This study consists of a prospective clinical trial which aims to evaluate the impact of
stent insertion for palliation of malignant dysphagia. The main goal being to examine the
number of days required following stenting in order to have significant improvement in
dysphagia and the length of time that this baseline is maintained.


Intraluminal esophageal stenting improves malignant dysphagia and quality of life almost
immediately after stent insertion and this effect is maintained in the short and medium term
in inoperable esophageal cancer patients.


- To assess the effectiveness of esophageal stenting in improving malignant dysphagia and
assess the time period relating to this improvement

- To assess the effectiveness of esophageal stenting in improving quality and assess the
time period relating to this improvement

Study design:

Prospective non-interventional clinical trial.


Patients with malignant dysphagia who are scheduled for palliative endoluminal esophageal
stenting will be prospectively enrolled into the trial. All patients eligible for the study
will be consented by study investigators in the outpatient clinic prior to their procedure.
Study investigators will administer the questionnaires following consent.

Patients will undergo the standard endoscopic intervention of intraluminal esophageal stent

Assessment of dysphagia score will be performed immediately prior to the procedure, after
the procedure (day 0), as well as days 1 to 7, then every week for 4 weeks post procedure.

Questionnaires performed by study investigators will take place in either the clinic before
the operation or in Notre-Dame hospital during hospital stay. Later questionnaires will be
performed by telephone interview.

Analysis will aim to compare dysphagia and quality of life scores between baseline
(pre-procedure) values and post-procedural values. The time to achieve a steady state will
also be assessed. Maintenance of improved quality of life and of low dysphagia score will
also be assessed. Secondary outcome will be a survival analysis based on stage.

Inclusion Criteria:

- All patients with end stage inoperable esophageal cancer deemed candidates for
intraluminal esophageal palliative stent insertions.

Exclusion Criteria:

- Inability to consent for the study.

- Patients less than 18 years old.

- Patients with other benign causes of dysphagia and esophageal obstruction or

- Patients with malignant or benign airway - esophageal fistulas.

- Patients with cervical esophageal cancer

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

improvement of dysphagia post stenting

Outcome Description:

To assess the effectiveness of esophageal stenting in improving malignant dysphagia and assess the time period relating to this improvement

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Moishe Liberman, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHUM-Centre Universitaire de Montreal


Canada: Ethics Review Committee

Study ID:

CE 11.039



Start Date:

June 2011

Completion Date:

August 2015

Related Keywords:

  • Esophageal Cancer
  • esophageal stenting
  • palliative
  • dysphagia
  • Deglutition Disorders
  • Esophageal Diseases
  • Esophageal Neoplasms