Cattell-Warren versus Blumgart techniques of pancreatico-jejunostomy following pancreato-­duodenectomy

ISRCTN ISRCTN52263879
DOI https://doi.org/10.1186/ISRCTN52263879
Protocol serial number 17639
Sponsor University of Liverpool
Funder Cancer Research UK
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

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-two-different-ways-of-joining-the-pancreas-to-the-bowel-during-surgery-for-pancreatic-cancer-panasta

Contact information

Dr Kellie Platt
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

Primary study designInterventional
Study designRandomised; Interventional
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleCattell-Warren versus Blumgart techniques of pancreatico-jejunostomy following pancreato­-duodenectomy:  ­a double blinded multicentred trial
Study acronymPANasta
Study objectivesThis 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) studiedTopic: Cancer, Surgery, Gastroenterology; Subtopic: Upper Gastro-Intestinal Cancer, Surgery, Gastroenterology; Disease: Pancreas
Intervention1. 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 typeProcedure/Surgery
Primary outcome measure(s)

Post-operative pancreatic fistula (POPF); Timepoint(s): Post-operative day 3, 5, 7, discharge and 3 month follow up

Key secondary outcome measure(s)

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

Completion date01/02/2019

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration506
Key inclusion criteriaSubjects 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 criteriaSubjects 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 enrolment24/04/2015
Date of final enrolment02/08/2017

Locations

Countries of recruitment

  • United Kingdom
  • England

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

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
IPD sharing planNot 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
HRA research summary 28/06/2023 No No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
Plain English results 17/02/2023 No Yes

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.

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