E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The effect of epidural anaesthesia on systemic and splanchnic hemodynamic during gastroesophageal cancer resection |
Effekt af epidural anæstesi på systemisk og splanknisk hæmodynamik under esophagusresektion |
|
E.1.1.1 | Medical condition in easily understood language |
The effect of epidural anaesthesia on systemic and local blood flow during stomach cancer operation |
Effekt af epidural bedøvelse på systemisk og lokal blodgennemstrømning under operation for mavemundscancer |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066354 |
E.1.2 | Term | Adenocarcinoma of the gastroesophageal junction |
E.1.2 | System Organ Class | 100000004864 |
|
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 |
Epidural anaesthesia reduces the sympathetic response, thereby possibly inhibiting the microcirculation in the splanchnic system, especially in the gastric conduit. With this study, we wish to evaluate hemodynamic fluctuations and gastric circulation as well as vasodilatory substances (e.g. PGI2) in relevant intervals from the activation of epidural analgesia.
The hypothesis is that epidural analgesia reduces sympathetic nerve activity and thereby inhibiting the splanhcnic microcirculation, especially in the gastric conduit. Late activation of epidural analgesia is believed to be more advantageous. |
Epidural anæstesi reducerer det systemiske response hvilket kan reducere microcirkulationen i splanchnicus, specielt i det gastriske konduit. Formålet med studiet er at vurdere de hæmodynamiske fluktuationer, microcrokulationen i det gastriske konduit, samt ændringer i de vasoaktive stoffers koncentrationer efter aktivering af epidural anæstesi.
Hypotesen er at epidural analgesi sænker sympatisk nerveaktivitet og hæmmer dermed microcirkulationen i splanchnicus og specielt i ventrikelrøret, hvorfor sen aktivering af epidural analgesi er fordelagtigt.
|
|
E.2.2 | Secondary objectives of the trial |
The secondary objective is to investigate the surgical stress response during and after surgery and the rate of postoperative complications, such as anstomotic leakage, infections, and pulmonary complications, in relation with early or late activation of epidural anaesthesia. |
Det sekundære formål er at undersøge det kirurgiske stress-response under og efter kirurgi og forekomsten af ​​postoperative komplikationer, såsom anstomose lækage, infektioner og pulmonale komplikationer i forbindelse med tidlig versus sen aktivering af epidural anæstesi. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patiens over 18 years of age planned for gastroesophageal resection due to adenocarcinoma of the gastroesophageal junction.
No discriminations of ethnic or gender.
|
Voksne (>18 år) og myndige patienter, der skal undergå åben esophagusresektion for biopsiverificeret adenocarcinom. Ingen krav til etnicitet eller køn.
|
|
E.4 | Principal exclusion criteria |
Lack of consent.
Patients planned for robot-assisted surgery. |
Manglende samtykke.
Patienter der skal gennemgå robot-assisterede operationer |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Significant alterations in microcirculation in the gastric conduit related to early versus late activation of epidural anaesthesia.
The study will be stopped when 50 patients have been randomised to early or late activation af epidural anaesthesia during surgery. |
Signifikante ændringer i mikrocirkulationen i det gastriske konduit, relateret til tidlig versus sen aktivering af epidural anæstesi.
Undersøgelsen stoppes, når 50 patienter er blevet randomiseret til tidlig eller sen aktivering of epidural anæstesi under operation. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
The first evaluation will be made when 20 patients have been included. During the study period, interim-analyzes will be made every sixth months until 50 patients have been included. |
Den første interimanalyse foretages når 20 patienter er inkluderet. I løbet af undersøgelses perioden foretages interimanalyser hver sjette måned indtil 50 patienter er inkluderet. |
|
E.5.2 | Secondary end point(s) |
Significant differences of intra- and postoperative levels of surgical response between the groups, defined as alterations in serum cortisol, aldosterone, adrenaline, noradrenaline, and ACTH.
Significant alterations in the plasmalevels og atrial natriuretic hormon (ANP), prostacyclin and GLP-1
Significant differences in the rate of postoperative complications between the groups, such as anastomotic leakage, infections, pulmonary complications, and death.
|
Signifikante forskelle i intra- og postoperative niveauer af kirurgisk stress response mellem grupperne , defineret som ændringer i cortisol, aldosteron, adrenalin, noradrenalin og ACTH.
Signifikante ændringer i plasmaniveauer af atrial natriuretisk hormon (ANP), prostacyclin og GLP-1
Signifikante forskelle i antallet af postoperative komplikationer mellem grupperne, såsom anastomotisk lækage, infektioner, pulmonale komplikationer og død.
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
The first evaluation will be made when 20 patients have been included. During the study period, interim-analyzes will be made every sixth months until 50 patients have been included. |
Den første interimanalyse foretages når 20 patienter er inkluderet. I løbet af undersøgelses perioden foretages interimanalyser hver sjette måned indtil 50 patienter er inkluderet. |
|
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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
E.8.1.4 | Double blind | Yes |
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 |
Early versus Late activation of epidura anaesthesia. No other medicinal products will de used |
The effect of epidural anaesthesia is compared between a early and late activation. |
|
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
| 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 | 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 study will be stopped if there the rate of anastomotic leakage is over 15 % at the interim-analyzes. If the high leakage-rate is due to time of activation of epidural anaesthesia, the study will be stopped permanently.
Also, the study will bee stopped at the occurence of a Serious Adverse Event/Suspected Unexpected Serious Adverse Reaction, related to the time of activation of epidural anaesthesia. |
Forsøget stoppes hvis der ses en lækage-rate over 15 % ved interimanalyser. Såfremt konklusionen skulle være, at den høje lækage-rate skulle være forårsaget af sen aktivering af epidural analgesi, afsluttes forsøget med det samme.
Forsøget stoppes hvis en Serious Adverse Event/Suspected Unexpected Serious Adverse Reaction kan relateres til tidlig aktivering af epidural anæstesi. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |