Best Analgesia Control in Pancreatic Adenocarcinoma Study
Research type
Research Study
Full title
The “BAC-PAC Study” - Best Analgesia Control in Pancreatic Adenocarcinoma. An observational study to justify and plan a future randomised clinical trial of early endoscopic therapy versus conventional strong opiate analgesic drugs, assessing the effect on quality of life through enhanced pain relief in patients with inoperable pancreatic adenocarcinoma.
IRAS ID
261591
Contact name
Andrew Hart
Contact email
Sponsor organisation
University of East Anglia
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Many patients with pancreatic cancer (PAC) have severe belly (abdominal) pain, for which doctors prescribe strong opiate analgesic drugs (SOADs), such as morphine. Unfortunately, SOADs can cause debilitating side-effects which impair patients’ quality of life (QoL) and may not completely relief pain. New treatments for controlling pain better than SOADs are needed. Possible options are endoscopic treatments (ETs) where patients swallow a flexible telescope through which pain relieving treatments are delivered directly to the pancreas. These ETs either block nerves transmitting pain signals from the pancreas or relieve blockages in the pancreas’ drainage system caused by cancer. Whether ‘ETs given early’ are better than SOADs needs to be tested in a future research trial. In this future trial, half the patients would be given an ET and half standard SOAD. Differences between the two patient groups in pain control and QoL would be assessed. However, before such clinical trial can start, several important unknowns need to be addressed which "The Best Analgesic Control-in-Pancreatic Cancer Study" (BAC-PAC) will do.
These are:
- proportion of patients who develop pain
- if patients are medically fit for ETs when they first develop belly(abdominal) pain
- if they live for long enough after the onset of pain
- the proportion of them where ETs are contra-indicated
- if specific CT findings can predict the development of pain
- what is patients’ experience of having endoscopy for diagnostic purposes
- whether patients have preferences for ET or SOADs
- if QoL of individuals who look after patients with pain is affected.The above information will be collected through short questionnaires which all patients and their relative or close friend will be invited to complete for a few months and through and semi-structured interviews which they will attend. This information will justify and inform the development of a trial.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
19/EM/0230
Date of REC Opinion
14 Aug 2019
REC opinion
Further Information Favourable Opinion