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Effect of Palliative Biliary Stenting Versus Conservative Treatment on the Quality of Life (QOL) of Patients With Unresectable Carcinoma of the Gallbladder With Hiliar Block: A Randomised Controlled Trial

Phase 2/Phase 3
18 Years
90 Years
Open (Enrolling)
Gallbladder Cancer

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Trial Information

Effect of Palliative Biliary Stenting Versus Conservative Treatment on the Quality of Life (QOL) of Patients With Unresectable Carcinoma of the Gallbladder With Hiliar Block: A Randomised Controlled Trial

For most patients with gallbladder cancer, cure is not possible and treatment should be
therefore aimed at palliation of symptoms and maintaining quality of life (QOL) in the few
months between diagnosis and death. Most of these patients suffer from intractable pruritis,
pain, anorexia and general debility. Biliary stenting leads to a reduction in pruritis and
jaundice, and is commonly offered to many unresectable patients. However stenting related
complications like cholangitis, rescue percutaneous treatment and need for prolonged
hospitalization often impair the remaining short survival of these patients. In these
patients improving the QOL should be the primary focus, and survival a secondary end point
in disease management. No study has addressed the issue of QOL of patients with gallbladder
cancer, post stenting.

Three clinical studies have evaluated the change in the QOL of patients with malignant
biliary obstruction after of endoscopic stenting. Ballinger et al evaluated 19 patients
with unresectable pancreatic carcinoma before stenting and upto 12 weeks or death after
stenting. The Rotterdam Symptom Checklist and the Hospital Anxiety and Depression Scale were
used. Significant improvements were seen in the parameters of mood, indigestion, appetite
and level of activity. Luman et al studied 47 inoperable patients with malignant biliary
strictures. The European Organisation for Research and Treatment of Cancer QOL questionnaire
(EORTC QLQ-C30) was used at baseline and 1 month after stenting. For patients successfully
completing the follow up, significant improvement in emotional, cognitive , and global
health scores was found after stenting. In addition to the expected improvement in pruritis
and jaundice , anorexia, diarrhea and sleep pattern were also improved. Abraham et al
studied 50 patients with malignant biliary obstruction without liver metastasis considered
non surgical candidates, and undergoing palliative biliary stenting. The SF-36 Health Survey
Questionnaire was used to quantify QOL at baseline and 1 month after stent insertion. Follow
up data was available for only 26 patients. Among these patients a significant reduction in
the bilirubin level was associated with improvement in the social function and mental
health. A high baseline bilirubin (> 14mg/dL) was associated with a lack of improvement at 1
month follow up.

Hence existing data regarding improvement in the QOL of patients undergoing palliative
biliary stenting is sparce and incomplete. Gallbladder cancer presenting a hilar block is
the most common biliary malignancy in India. Hilar tumors are associated with more technical
failure of stenting, higher cholangitis rates, earlier stent blockage, and shorter survival
as compared to distal biliary tumors. Only 6 patients with Klatskin tumors were included
in one of the study.8 Patients with hilar block were either not included6, or were not
specified7 in the other studies.

Health related quality of life (QOL) refers to the impact of a medical condition or its
treatment on a person's expected physical, psychological and social well being.

Calman states that QOL evaluations measure the difference between the "hopes and
expectations" of an individual and that individual's present experience.

The multidimensionality that is commonly assessed in QOL measures includes

1. Physical symptoms of the disease or its treatment or concurrent illness.

2. Functional capacity (ability and energy) for daily routine, social interactions,
intellectual activity, emotional reactions and adjustments, economic independence.

3. Self-perception of wellness or its absence. There are two basic types of instruments
for measuring the QOL: generic and disease specific. Generic instruments focus on the
main components that constitute QOL, and are intended to be applied in a wide range of
populations and health states across all diseases. There are many excellent validated
self-completion questionnaires for cancer patients eg. EORTC QOL questionnaire,
Functional assessment of Cancer Therapy (FACT), Rotterdam Symptom Checklist (RSCL),
Functional Living Index Cancer (FLIC). All these questionnaires are multidimensional,
and it is rarely required to develop a new instrument.

The EORTC QLQ-C30 has been developed in a multi-cultural setting, and translations are
available in 43 languages. The instrument has been shown to be valid, reliable, and
responsive to change. Disease specific modules are available to supplement the core
questionnaire. Reference data is available for calculating sample size. The questionnaire is
easily understood by most patients and is quick to complete (mean time 11 minutes).

The EORTC QLQ-C30 is a 30- item questionnaire composed of multi-item scales and single items
that reflects the multidimensionality of the quality of life construct. It incorporates five
functional scales (physical, role, cognitive, emotional, and social), three symptom scales
(fatigue, pain, nausea and vomiting), and a global health and quality of life scale. The
remaining single items assess additional symptoms commonly reported by cancer patients
(dyspnea, appetite loss, sleep disturbance, constipation and diarrhea), as well as the
perceived financial impact of the disease and its treatment. The functional scales have 16
questions, symptom scales have 6 questions, global quality of life has two questions, and
there are six single item questions. For ease of interpretation, all scale and item scores
are linearly transformed to a 0 to 100 scale. For the 5 functional scales and the global
quality of life scale, a higher score represents a better level of functioning. For the
symptom oriented scales and items, a higher score corresponds to a higher level of symptoms.

Hence we plan to prospectively study unresectable gallbladder cancer patients with hilar
block to evaluate whether palliative stenting improves their quality of life, and whether
the benefit afforded outweighs the early and late complications of stenting.

Inclusion Criteria:

1. Patients with unresectable gallbladder cancer (Bismuth type II to IV).

2. Eastern Cooperative Oncology Group Performance (ECOG) status 0-3.

Exclusion Criteria:

1. Preoperative stenting

2. ECOG status 4

3. Distant residence precluding follow up visits, or unwillingness to return for follow

4. Poor comprehension of the Hindi QOL questionnaire.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Improvement in the physical functioning scale (containing five items) of EORTC QLQ-30 one month after after biliary stenting.

Outcome Time Frame:

30 days

Safety Issue:


Principal Investigator

Pramod Garg, M.D, D.M.

Investigator Role:

Study Director

Investigator Affiliation:

All India Institute of Medical Sciences, New Delhi


India: Ministry of Health

Study ID:




Start Date:

January 2006

Completion Date:

December 2012

Related Keywords:

  • Gallbladder Cancer
  • Gallbladder cancer
  • Quality of life
  • Stenting
  • Survival
  • Performance status
  • Carcinoma
  • Gallbladder Neoplasms