Cattell-Warren versus Blumgart techniques of pancreatico-jejunostomy following pancreato-duodenectomy
| ISRCTN | ISRCTN52263879 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52263879 |
| Secondary identifying numbers | 17639 |
- Submission date
- 14/01/2015
- Registration date
- 15/01/2015
- Last edited
- 17/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr Kellie Platt
Scientific
Scientific
Cancer Research UK Liverpool Cancer Trials Unit
University of Liverpool
1st floor Block C
Waterhouse Building
3 Brownlow Street
Liverpool
L69 3GL
United Kingdom
Study information
| Study design | Randomised; Interventional |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| Scientific title | Cattell-Warren versus Blumgart techniques of pancreatico-jejunostomy following pancreato-duodenectomy: a double blinded multicentred trial |
| Study acronym | PANasta |
| Study objectives | This study will aim to compare the effectiveness of two techniques of pancreaticojejunostomy; Cattell-Warren versus Blumgart follwing pancreatoduodenectomy. |
| Ethics approval(s) | NRES Committee North West - Greater Manchester South, 22/12/2014, ref: 14/NW/1393 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/07/2014 |
| Completion date | 01/02/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | 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%. |
| Key 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 |
| Key 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 |
| Date of first enrolment | 24/04/2015 |
| Date of final enrolment | 02/08/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study 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
1st floor Block C
Waterhouse Building
3 Brownlow Street
Liverpool
L69 3GL
United Kingdom
Sponsor information
University of Liverpool
Hospital/treatment centre
Hospital/treatment centre
Foresight Centre
1-3 Brownlow Street
Liverpool
L69 3GL
England
United Kingdom
"ROR" |
https://ror.org/04xs57h96 |
|---|
Funders
Funder type
Government
Cancer Research UK
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/04/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Current publication and dissemination plan as of 10/02/2020: Planned clinical case study report, publication in peer-reviewed scientific journals, and conference presentations in May/June 2020. Previous publication and dissemination plan: To be confirmed at a later date |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 15/01/2016 | Yes | No | |
| Basic results | 14/01/2021 | 15/01/2021 | No | No | |
| Plain English results | 17/02/2023 | No | Yes | ||
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN52263879_BasicResults_14Jan2021.pdf
- Uploaded 15/01/2021
Editorial Notes
17/02/2023: A link to plain English results on CRUK was added.
15/01/2021: The basic results of this trial have been uploaded as an additional file.
17/12/2020: Internal review.
10/02/2020: The following changes have been made:
1. The publication and dissemination plan has been updated.
2. The intention to publish date has been changed from 01/02/2020 to 01/04/2020.
15/02/2018: The recruitment end date has been updated from 31/01/2018 to 02/08/2017. The overall trial end date has been updated from 01/07/2019 to 01/02/2019. The intention to publish date has been added.
18/01/2016: Added publication reference.
