Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
17639
Study information
Scientific title
Cattell-Warren versus Blumgart techniques of pancreatico-jejunostomy following pancreato-duodenectomy: a double blinded multicentred trial
Acronym
PANasta
Study hypothesis
This study will aim to compare the effectiveness of two techniques of pancreaticojejunostomy; Cattell-Warren versus Blumgart follwing pancreatoduodenectomy.
Ethics approval
NRES Committee North West - Greater Manchester South, 22/12/2014, ref: 14/NW/1393
Study design
Randomised; Interventional
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Condition
Topic: Cancer, Surgery, Gastroenterology; Subtopic: Upper Gastro-Intestinal Cancer, Surgery, Gastroenterology; Disease: Pancreas
Intervention
1. Blumgart anastomosis, Re-construction of the pancreatic remnant following pancreato-duodenectomy using a Blumgart method
2. Cattell-Warren anastomosis, Re-construction of the pancreatic remnant following pancreato-duodenectomy using a Cattell-Warren method of pancreatico-jejunostomy
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Post-operative pancreatic fistula (POPF); Timepoint(s): Post-operative day 3, 5, 7, discharge and 3 month follow up
Secondary outcome measures
1. Entry into programs of adjuvant therapy / clinical trials of adjuvant therapy; Timepoint(s): 3, 6 and 12 month follow up;
2. Health economic evaluation; Timepoint(s): Enrolment, discharge ad 3, 6 and 12 month follow up
3. Length of hospital stay; Timepoint(s): Discharge, 3, 6 and 12 month follow up
4. Mortality Rate; Timepoint(s): Death due to any cause during the study period will be recorded
5. Operation time; Timepoint(s): Day of surgery
6. Quality of Life; Timepoint(s): Enrolment, discharge and 3, 6 and 12 month follow up
7. Rate of delayed gastric emptying; Timepoint(s): Post-operative day 3, 5, 7 and discharge
8. Rate of intra and post-operative bleeding; Timepoint(s): day of surgery, post-operative day 3, 5, 7 and discharge
9. Rate of post-operative fluid collections; Timepoint(s): Post-operative day 3, 5, 7, discharge and 3 month follow up
10. Rate of pulmonary infection; Timepoint(s): Discharge and 3 month follow up
11. Rate of re-operation; Timepoint(s): Post-operative day 3, 5, 7, discharge and 3, 6 and 12 month follow up
12. Rate of venous thrombo-embolism; Timepoint(s): Post-operative day 3, 5, 7 and discharge and 3, 6 and 12 month follow up
13. Rate of wound infections; Timepoint(s): Post-operative days 3, 5, 7, discharge and 3, 6 and 12 month follow up
Overall trial start date
01/07/2014
Overall trial end date
01/02/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Subjects meeting all of the following criteria will be considered for this trial:
1. Patients undergoing an elective pancreato duodenectomy for presumed malignancy of the head of the pancreas
2. Ability of the subject to understand the nature and consequences of the trial
3. Ability to provide written informed consent.; Target Gender: Male & Female ; Lower Age Limit 18 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 506; UK Sample Size: 506; Description: The total sample of 506 patients (253 in each arm) has been calculated to detect a 10% attrition rate of 5%. Non-compliance would occur in the event of unresectable disease, assumed at 10%.
Participant exclusion criteria
Subjects with the following criteria will not be entered into this trial:
1. Patients undergoing extended pancreatoduodenectomy
2. Left, central or total pancreatectomy
3. Arterial resection or multivisceral resection
4. Previous pancreatic resection
5. Surgery for known chronic pancreatitis
6. Recruited to any other pancreatic resection trial.
7. Pregnant women
Recruitment start date
24/04/2015
Recruitment end date
02/08/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Liverpool
Cancer Research UK Liverpool Cancer Trials Unit
1st floor Block C
Waterhouse Building
3 Brownlow Street
Liverpool
L69 3GL
United Kingdom
Funders
Funder type
Government
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
01/02/2020
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2016 protocol in http://www.ncbi.nlm.nih.gov/pubmed/26772736