E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Anastomotic leakage |
Lekkage van anastomose |
|
E.1.1.1 | Medical condition in easily understood language |
Conjunction leakage |
Naadlekkage |
|
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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065961 |
E.1.2 | Term | Esophageal anastomotic leak |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065890 |
E.1.2 | Term | Oesophageal anastomotic leak |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
|
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 |
Evaluation of the feasibility of Tachosil application on esophageal anastomoses. |
Evaluatie van de haalbaarheid van het aanbrengen van tachosil op oesofageale anastomosen. |
|
E.2.2 | Secondary objectives of the trial |
Evaluation of the safety of Tachosil application on esophageal anastomoses. |
Evaluatie van de veiligheid van het aanbrengen van tachosil op oesofageale anastomosen. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients undergoing an elective total gastrectomy with an esophago-jejunostomy or esophagectomy with a planned esophagogastric anastomosis
• Ages 18-80
• Signed informed consent |
• Patienten die een electieve totale maagresectie met oesofago-jejunostomie of oesofagus resectie met oesofago-gastrostomie ondergaan.
• Leeftijd 18-80
• Ondertekende toestemmingverklaring |
|
E.4 | Principal exclusion criteria |
• Emergency resections of esophagus of stomach
• History of hypersensitivity reactions to human fibrinogen, human thrombin, or collagen.
• Patients having difficulty understanding the Dutch and English language
• Mentally incapable patients
• Pregnancy or breast feeding |
• Spoed resecties van oesofagus of maag
• Voorgeschiedenis van hypersensitiviteit reacties op humaan fibrinogeen, humaan thrombine of collageen.
• Patienten die geen Nederlands of Engels verstaan
• Wilsonbekwame personen
• Zwangerschap of borstvoeding |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy parameter is the feasibility of TachoSil® application on esophageal anastomoses, which is assessed by 2 investigators who will evaluate video recordings. Feasibility is measured by the adherence and location of the TachoSil® patch, defined according to the following criteria:
• Adherence of complete TachoSil® patch
• TachoSil® covers at least 1 cm beyond the margins of anastomotic line
• Overlap of at least 1 cm if multiple patches are used |
De primaire uitkomst maat is het onderzoeken van de haalbaarheid van het aanbrengen van tachosil op oesofageale anastomosen. Dit zal onderzocht worden door 2 onderzoekers aan de hand van video opnames. De haalbaarheid wordt geobjectiveerd door de mate van het vasthechten van tachosil en de locatie van tachosil, gedefineerd als:
• Vasthechten van complete tachosil patch
• Tachosil bedekt minimaal 1 cm voorbij de anastomose
• Patches overlappen minimaal 1cm, indien meerdere patches worden gebruikt. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Duration of construction of the anastomosis, during surgery. |
Duur van het aanleggen van de anastomose, tijdens de operatie. |
|
E.5.2 | Secondary end point(s) |
Safety
• Mortality
- 30-day (n)
- 60-day (n)
- in hospital (n)
• Serious adverse events (n)
• Adverse events (n)
• Anastomotic leakage (n)
• Location of anastomotic leakage
- Cervical (n)
- Intrathoracic (n)
• Anastomotic stricture (n)
• Post-operative complications (n): Respiratory complications (pneumonia, ARDS, respiratory insufficiency), cardiac complications (ischemic and arrhythmic), lymphorrhea, vocal-cord paralysis, sepsis, urinary tract infection, wound infection, fistula, mediastinitis, thorax empyema.
• Postoperative course:
- Duration of Intensive Care stay (days)
- Duration of Medium Care stay (days)
- Total duration of hospital stay (days)
- Mechanical ventilation (days)
|
Veiligheid
• Mortaliteit
- 30-dagen (n)
- 60-dagen (n)
- in ziekenhuis (n)
• Serious adverse events (n)
• Adverse events (n)
• Naadlekkage (n)
• Locatie naadlekkage
- Cervicaal (n)
- Intrathoracaal (n)
• Stenose ter plaatse van anastomose (n)
• Postoperatieve complicaties (n): Respiratoire complicaties (pneumonie, ARDS, respiratoire insufficientie), cardiale complicaties (ischemie and arrhythmie), chylus lekkage, stemband paralyse, sepsis, urine weg infectie, wond infectie, fistel, mediastinitis, thorax empyeem.
• Postoperatief beloop:
- Duur Intensive Care opname (dagen)
- Duur Medium Care opname (dagen)
- Total duration of hospital opname (dagen)
- Mechanische ventilatie (dagen)
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day of Surgery (day 0)
Day of discharge from surgical ward
3 months after surgery
9 months after surgery
|
Dag van operatie (dag 0)
Dag van ontslag van afdeling heelkunde
3 maanden na operatie
9 maanden na operatie |
|
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 | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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 | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
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 planned end-of-trial is defined as the last visit of the last participant. The last visit takes place 9 months after initial surgery. According to our UMCU database >95% of the patients with anastomotic stenosis will present at the outpatient visit with symptoms within 9 months.
|
Het geplande einde-van-trial is gedefineerd als het laatste bezoek van de laatste deelnemer. Het laatste bezoek vindt plaats 9 maanden na initiele operatie. Volgens onze UMCU database zullen zich binnen 9 maanden >95% van de patienten met een stenose ter plaatse van de anastomose gemeld hebben op de polikliniek. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |