Palliative Biliary Stenting on the Quality of Life of Patients With Unresectable Carcinoma Gallbladder With Hiliar Block.
Condition: Gallbladder Cancer
MeSH terms: Gallbladder Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of the study is to determine whether palliative biliary stenting improves the
      quality of life, of gallblader cancer patients, who present with hilar block and obstructive
      jaundice.
    

Detailed description: 
      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.
    

Intervention name(s): Biliary stenting
Intervention type(s): Procedure
Intervention description(s): ERCP and stenting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Gallbladder cancer; Quality of life; Stenting; Survival; Performance status