Health Condition 1: null- Patients presenting with dysphagia in patients of Head and neck cancer and Carcinoma oesophagus
Conditions
Interventions
Intervention1: Percutaneous Radiologic Gastrostomy: Gastric puncture will be performed with a 17-gauge puncture needle preloaded with an anchor (Cope gastrointestinal suture anchor sets
Cook). An intragastric position is confirmed by aspiration of air into a syringe and/or injection of contrast, outlining gastric rugal folds. The anchor is then deployed by passing a guidewire through
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: a)- Patients diagnosed to have carcinoma esophagus and head and neck squamous cell carcinoma presenting with significant dysphagia requiring nutritional supplementation. b)- treatment naïve patients having performance status less than or equal to ECOG 2 c)- Patients between age of 18 to 75 years
Exclusion criteria
Exclusion criteria: a)- Patients fit for upfront surgery not requiring adjuvant chemoradiotherapy. b)- Refusal to give consent c)- performance status >ECOG 2 at presentation d)- Patients who have received treatment previously. e)- Patients with uncorrectable coagulopathy f)- Patients with absolute dysphagia with multiple failed attempts of NG tube insertion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient discomfort and Quality of Life using a)-EORTC QLQ OES-18 score pre and post treatment. b)- Comfort level with the mode of nutrition (scale 1-10) c)- Number of hospital visits/readmissions attributable to gastrostomy/NG tube d)- Pain/discomfort level (NPS 1-10) e)- Would you (patient) choose the same mode of feeding if given an option again? Timepoint: 3 months and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect on nutritional parameters: a)- Maximum weight loss/gain during treatment (chemoradiotherapy) b)- BMI with lean body mass c)- Mid upper arm circumference (MUAC) d)- Triceps skinfold thickness (TST) e)- Treatment algorithm delay due to nutritional insufficiency f)- Treatment protocol change due to nutritional insufficiency Timepoint: Baseline, 1 month, 3 months and 6 months post procedure;Success and complication of Procedure Procedural success rate of both gastrostomy and NG tube insertion will be documented. Dropouts will be treated based on intention to treat analysis. Procedural Complications to be assessed: a)- Peristomal leakage, peristomal bleeding/hematoma, tube blockage or dislodgement, peritonitis-RIG b)- Inadvertent removal, sinusitis, mucosal erosions in NG feeding Timepoint: 1, 3 and 6 months | — |
Countries
India
Contacts
Public ContactDr Mukesh Kumar
BRAIRCH, AIIMS, New Delhi
Outcome results
None listed