Topic: Cancer, Surgery, Gastroenterology
Conditions
Interventions
1. Blumgart anastomosis, Re-construction of the pancreatic remnant following pancreato-duodenectomy using a Blumgart method
2. Cattell-Warren anastomosis, Re-construction of the pancre
Sponsors
University of Liverpool
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-operative pancreatic fistula (POPF); Timepoint(s): Post-operative day 3, 5, 7, discharge and 3 month follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Outcome results
None listed