Condition category
Digestive System
Date applied
14/01/2015
Date assigned
15/01/2015
Last edited
18/01/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Dr Kellie Platt

ORCID ID

Contact details

Cancer Research UK Liverpool Cancer Trials Unit
University of Liverpool
1st floor Block C
Waterhouse Building
3 Brownlow Street
Liverpool
L69 3GL
United Kingdom

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 measures

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

01/07/2019

Reason abandoned

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

31/01/2018

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

Sponsor information

Organisation

University of Liverpool

Sponsor details

Foresight Centre
1-3 Brownlow Street
Liverpool
L69 3GL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2016 protocol in http://www.ncbi.nlm.nih.gov/pubmed/26772736

Publication citations

Additional files

Editorial Notes

18/01/2016: Added publication reference.