E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The dehiscence of the esophagojejunal anastomosis after a total gastrectomy in patients with gastric adenocarcinoma |
La dehiscencia de la anastomosis esofagoyeyunal después de una gastrectomía total en pacientes con adenocarcinoma gástrico |
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E.1.1.1 | Medical condition in easily understood language |
Leakage of the esophagojejunal anastomosis in patients who underwent a total gastrectomy due to gastric adenocarcinoma |
Fuga de la anastomosis esofagoyeyunal en pacientes sometidos a una gastrectomía total por adenocarcinoma gástrico |
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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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10058439 |
E.1.2 | Term | Esophageal anastomosis |
E.1.2 | System Organ Class | 100000004865 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013121 |
E.1.2 | Term | Diseases of esophagus |
E.1.2 | System Organ Class | 100000004856 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10075515 |
E.1.2 | Term | Stoma site leakage |
E.1.2 | System Organ Class | 100000004863 |
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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 evaluate the effectiveness of a fibrin-based tissue adhesive (Tisseal) to reduce the incidence of dehiscence in esophagojejunal anastomoses in total gastrectomies due to cancer. |
Evaluar la eficacia de un adhesivo tisular a base de fibrina (Tisseal) para disminuir la incidencia de dehiscencia en las anastomosis esófagoyeyunales en las gastrectomías totales por cáncer. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients of both sexes older than 18 years. - Diagnosis of gastric adenocarcinoma with the possibility of total gastrectomy with curative intention. - Patients with reference centers in the participating autonomies. - Understand and accept the trial procedures and sign an informed consent. |
- Pacientes de ambos sexos mayores de 18 años. - Diagnóstico de adenocarcinoma gástrico con posibilidad de gastrectomía total con intención curativa. - Pacientes con centros de referencia en las autonomías participantes. - Comprender y aceptar los procedimientos del ensayo y firmar un consentimiento informado. |
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E.4 | Principal exclusion criteria |
- Failure to meet the inclusion criteria. - Diagnosis of non-epithelial neoplasia, metastasis, patients with unresected tumor or undergoing palliative resections. - Subjects who have intolerance or have presented serious adverse reactions to products formed with a fibrin adhesive. - Pregnant or lactating women - Subjects who are not able to understand the nature of the essay and the procedures that they are asked to follow. - Do not sign informed consent. |
- No cumplir los criterios de inclusión. - Diagnóstico de neoplasia no epitelial, metástasis, pacientes con tumor no resecado o sometidos a resecciones paliativas. - Sujetos que presenten intolerancia o hayan presentado reacciones adversas graves a los productos formados a base de adhesivo de fibrina. - Mujeres embarazadas o lactantes - Sujetos que no sean capaces de entender la naturaleza del ensayo y los procedimientos que se les solicita seguir. - No firmar el consentimiento informado. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Dehiscence of suture diagnosed in the postoperative period using clinical and / or radiological parameters. Classification of Csendes |
Dehiscencia de sutura diagnosticada en el postoperatorio mediante parámetros clínicos y/o radiológicos. Clasificación de Csendes |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
A week of follow-up (after surgery) |
Una semana de seguimiento (después de la cirugía) |
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E.5.2 | Secondary end point(s) |
- Type of anastomosis performed: manual, mechanical (circular or linear) - Amylases in drainage on days 1,3,5,7 postoperatively or until drainage is withdrawn. - Leukocytes, procalcitonin, C-reactive protein in blood on days 0,1,3,5,7 postoperatively. - CT realization day with oral contrast. Findings of the TC according to the Goense score - Postoperative complication and type (Classification of Clavien Dindo) - Need for urgent surgical re-intervention - In-hospital and 90-day mortality - Date of hospital discharge - Re-entries at 30 and 90 days |
- Tipo de anastomosis realizada: manual, mecánica (circular o lineal) - Amilasas en drenaje en los días 1,3,5,7 postoperatorio o hasta la retirada del drenaje. - Leucocitos, procalcitonina, proteina C reactiva en sangre los días 0,1,3,5,7 postoperatorio. - Día de realización de la TC con contraste oral. Hallazgos de la TC según score Goense - Complicación postoperatoria y tipo (Clasificación de Clavien Dindo) - Necesidad de re-intervención quirúrgica urgente - Mortalidad intrahospitalaria y a los 90 días - Fecha de alta hospitalaria - Reingresos a los 30 y 90 días |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
A follow-up of 90 days after surgery |
Seguimiento de 90 días tras la cirugía |
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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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
Grupo no intervención |
Non interventional group |
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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 | 10 |
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
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The clinical trial will be considered completed after the full participation of the intended subjects to obtain the necessary data. It can be interrupted in the following cases: - Adverse events - Intercurrent diseases that may influence the results or health of volunteers - Concomitant medication or non-compliance by the subjects that may influence the results or the health of the volunteers - Cancellation by the developer |
El ensayo clínico se considerará finalizado tras la participación completa de los sujetos previstos para obtener los datos necesarios. Puede ser interrumpido en los siguientes supuestos: - Acontecimientos adversos - Enfermedades intercurrentes que puedan influir en los resultados o la salud de los voluntarios - Medicación concomitante o incumplimiento por parte de los sujetos que pueda influir en los resultados o la salud de los voluntarios - Cancelación por parte del promotor |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 24 |
E.8.9.1 | In the Member State concerned days | |