E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
pancreatic surgery - evaluation of the effect of fibrin-coated collagen |
|
E.1.1.1 | Medical condition in easily understood language |
pancreatic surgery - evaluation of the effect of fibrin-coated collagen |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10049192 |
E.1.2 | Term | Pancreatic fistula |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050457 |
E.1.2 | Term | Pancreatic anastomotic leak |
E.1.2 | System Organ Class | 100000004863 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
to demonstrate that fibrin-coated collagen patch (TachoSil) significantly decreases postoperative pancreatic leakage and prevents pancreatic fistula formation in patients undergoing partial pancreatico-duodenectomy with pancreato-enteric anastomosis |
|
E.2.2 | Secondary objectives of the trial |
To demonstrate superior efficacy of fibrin-coated collagen patch (TachoSil) in patients undergoing partial pancreato-duodenectomy, measured by
• any condition/complication in association with pancreatic fistula formation according to the clinical severity grading classification of pancreatic fistula (Grades A - C)
• the daily amount of fluid from the drainage and its content of amylase and lipase
• the time (days) until drain removal and until fistula closure
• surgery associated and any other perioperative complications |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• patients undergoing partial pancreatico-duodenectomy with pancreatico-jejunostomy
• age ≥ 18
• ability to comply with the protocol and attend follow up
• signed written informed consent |
|
E.4 | Principal exclusion criteria |
• known allergies against any product compound
• ongoing treatment with somatostatin or octreotid
• pregnant and lactating females
• haemolytic anaemia
• immune deficiency disease
• patients who are not eligible for general anaesthesia and operations
• concurrent participation in another clinical trial with the same primary endpoint is not permitted |
|
E.5 End points |
E.5.1 | Primary end point(s) |
evidence of pancreatic leakage or fistula according to ISGPF definition |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
evaluation after the third postoperative day |
|
E.5.2 | Secondary end point(s) |
• any conditions/complications in association with pancreatic fistula formation according to the clinical severity grading classification of pancreatic fistula (Grades A–C)
• the daily amount of fluid from the drainage, its content of amylase and lipase,
• the time (days) until drain removal and until fistula closure; the entire drain fluid volume will be measured over day of drainage and compared between groups.
• Surgery associated and any other perioperative complications according to a validated classification described by Clavien and Dindo et al
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
from surgery until fistula closure |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
the end of trial is defined with database closure |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 15 |