Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Lung Neoplasms

Pain

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Adjuvants, Anesthesia

Analgesics

Antipyretics

Bupivacaine

Fentanyl

Analgesics, Opioid

Acetaminophen

Anesthetics

Anesthetics, Local

Narcotics

Anesthetics, Intravenous

Anesthetics, General

Analgesics, Non-Narcotic

Epidural catheter: Bupivacain 1,0 mg/ml + Fentanyl 2 micrograms/ml. Oral analgesia: Paracetamol, NSAID and placebo tablets.

Epidural analgesia: Placebo. Oral analgesia: Paracetamol, NSAID and opioids tablets.

Bupivacain to be given in epidural catheter

Bupivacaine in epidural catheter

Fentanyl to be given in epidural catheter

Fentanyl in epidural catheter

Placebo (for Bupivacain and Fentanyl i epidural catheter)

Oral Paracetamol

Oral NSAID

Oral opioids

Placebo tablets to be given instead of oral opioids

Placebo (for oral opioids)

Jimmy H Holm, MD

Whereas it, in the case of conventional thoracotomy, has been demonstrated that thoracic epidural analgesia is more effective than systemic opioids in terms of pain relief and preservation of postoperative pulmonary function, the efficacy of epidural analgesia in video-assisted thoracic surgical (VATS) procedures, has not been sufficiently studied, but a beneficial effect might very well be present.

On the other hand, the risks associated with placement of a thoracic epidural catheter are well known and if similar pain relief can be achieved without it with no or only insignificant alternative side effects, this would be preferable.

The literature regarding the usefulness of epidural analgesia for reducing pain in Video-Assisted Thoracic Surgery is, at best, scarce with two small studies showing some effect and two showing no difference, none of the studies being blinded randomized controlled trials of adequate size.

The SEAVATS Study will try to answer this question.

Study plan:

The hypothesis is that there is no difference in the amount of pain the patients will experience after VATS for pulmonary neoplasms.

Study design and setting:

The project is designed as a prospectively, double blinded, randomized, placebo controlled study comparing pain in two groups of patients.

Both groups of patients will:

* Have a epidural catheter placed.
* Receive a basis level of analgesics consisting of paracetamol and a nonsteroidal anti- inflammatory drug combined with a nerveblock placed intercostally during surgery.
* Have access to i.v. opioids as needed for any experienced pain after surgery.

One group of patients will be given local anaesthetics through the epidural catheter supplemented with placebo medication orally while the other group will receive saline in the epidural catheter supplemented with opioids orally.

Data collection:

Data will, during hospitalization, be collected in the operating theatre, in the postoperative care unit and in the surgical ward. Six months after surgery a questionnaire will be send to the patients to do follow-up regarding residual sequelae after surgery and placement of epidural catheter. Further follow-up with questionnaire has been planned for subsequent years.

As a secondary objective, in fifty-six of the patients from The SEAVATS Study, blood samples will be gathered during surgery and one hour and 24 hours after surgery, and compared with pre-operative levels.

These blood samples will be analysed for immune cells (NK-cells, levels and activity) and cytokines (IL-6, IL-10, IL-12 and IFN-gamma) as indicators of immunological response to surgery.

Research ethics:

The project has obtained ethics approval from The Regional Scientific Ethical Committees for Southern Denmark and acceptance to perform clinical research has been granted by The Danish Health and Medicines Authority. Consent to data collection has been provided by The Danish Data Protection Agency. Before entering the project, consent will be obtained from all patients. Rigorous data security will be maintained for five years and afterwards all data will be deleted. The Study is registered with The European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) with EudraCT number 2014-000760-18 and is monitored by The Good Clinical Practice unit for Southern Denmark.

Supplementary Epidural Analgesia in Video-Assisted Thoracic Surgery (VATS) - The SEAVATS Study

Levels of NK-cells will be examined as an indicator of immunological response to surgery.

(The secondary outcomes "Immune cells", "Cytokines" and "Survival after VATS" should rightly have been registered in a separate sub study with a separate ClinicalTrials entry with "Immune cells - NK cell levels" as primary outcome measure and "Immune cells - NK cell activity", Cytokines" and "Survival after VATS" as a secondary outcomes as a separate sample size calculation was done to determine the needed inclusion for this part of the study. Now, instead, these outcomes will be defined as "Other Pre-specified Outcomes" with this explanation.)

The NK-cell activity will be examined as an indicator of immunological response to surgery.

(The secondary outcomes "Immune cells", "Cytokines" and "Survival after VATS" should rightly have been registered in a separate sub study with a separate ClinicalTrials entry with "Immune cells - NK cell levels" as primary outcome measure and "Immune cells - NK cell activity", Cytokines" and "Survival after VATS" as a secondary outcomes as a separate sample size calculation was done to determine the needed inclusion for this part of the study. Now, instead, these outcomes will be defined as "Other Pre-specified Outcomes" with this explanation.)

Levels of cytokines (IL-6, IL-10, IL-12 and IFN-gamma) will be examined as indicators of immunological response to surgery.

(The secondary outcomes "Immune cells", "Cytokines" and "Survival after VATS" should rightly have been registered in a separate sub study with a separate ClinicalTrials entry with "Immune cells - NK cell levels" as primary outcome measure and "Immune cells - NK cell activity", Cytokines" and "Survival after VATS" as a secondary outcomes as a separate sample size calculation was done to determine the needed inclusion for this part of the study. Now, instead, these outcomes will be defined as "Other Pre-specified Outcomes" with this explanation.)

Postoperative survival analysis. (The secondary outcomes "Immune cells", "Cytokines" and "Survival after VATS" should rightly have been registered in a separate sub study with a separate ClinicalTrials entry with "Immune cells" as primary outcome measure and "Cytokines" and "Survival after VATS" as a secondary outcomes as a separate sample size calculation was done to determine the needed inclusion for this part. Now, instead, these outcomes will be defined as "Other Pre-specified Outcomes" with this explanation.) (text initially added October 27th 2021, as the text was by mistake no included in the update after the protocol amendment 27 July 2016)

Self reported pain intensity 5 times a day both in rest and during activity until chest tube is removed or day 4 after operation is reached.

The consumption of i.v. opioids is registered daily until chest tube is removed or day 4 after operation is reached.

The duration of the surgical procedure will be registered.

Procedural time and competence level of MD placing catheter

Side effects observed using epidural analgesia including itching, nausea, vomiting, procedural pain, hypotension, dizziness, respiratory depression, reduced pulmonary function.

Questionnaire sent to patients 6, 12, 24 and 60 months after surgery. (criteria edited as part of a protocol amendment July 27th 2016 for a subsequent biomarkers study).

Odense University Hospital

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gastrointestinal Agents

Other Dietary Supplements

Pancrelipase

Benzocaine

Pancreatin

Tannic Acid

Those tumors located superior to the portal confluence were classified as Level I,

those tumors located on the confluence (involving the confluence) located on the portal confluence

those tumors located inferior to the portal confluence

For Level I-II tumors, in case of segmental resection of PV/SMV, the reconstruction was performed by an end-to-end anastomosis either by direct suture (for defect under 2 cm) or by using an interposition venous or prosthetic graft. For this purpose, autologous grafting we used internal jugular vein and cadaveric iliac vein and alternatively, synthetic PTFE graft was also used.

primary repair

segmental resection

Regarding Level III tumors, complete resection of the tumor was done either by tangential excision or by partial venous excision and subsequent reconstruction. To maintain a secure anastomosis, the mesenteric root was mobilized completely or/and splenic vein was divided.

graft reconstruction

In this retrospective study, we recorded the location of pancreatic tumors and relation/proximity to the portal vein. The surgical difficulty and requirement of additional interventions were also evaluated.

Between May 2014 and October 2018, all patients who underwent PD procedure were retrospectively reviewed. This retrospective cohort study identified all consecutive patients with T3 (stage IIA to III) adenocarcinoma of the head of the pancreas, who underwent concomitant venous (PV/SMV) resection. Those patients with locally advanced tumors that were not responded to neoadjuvant therapy were excluded. The local ethical committee was approved this study.

Data collection included demographical features, tumor characteristics including the PV level of the tumor considering computed tomography results, neoadjuvant therapy, surgical data, hospital stay, morbidity and mortality.

Anatomical classification was established based on the relationship between portal confluence (PC) and tumor location (Figure I). Those tumors located superior to the PC were classified as Level I, whereas tumors on the confluence inferiorly located to PC were classified as Level II and Level III.

Anatomical classification was established based on the relationship between portal confluence (PC) and tumor location . Those tumors located superior to the PC were classified as Level I, whereas tumors on the confluence inferiorly located to PC were classified as Level II and Level III.

A New Anatomical Classification of Portal Vein Location of Pancreas Tumors

A New Anatomical Classification of Portal Venous Involvement in Locally Advanced Pancreatic Cancer to Predict the Surgical Difficulty

any question about details can be shared via e-mail privately.

any mortality after/during surgery in the initial hospital stay

surgical complications observed during both operative and postoperative period

the time between the day of surgery and hospital discharge

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Supplementary Epidural Analgesia in Video-Assisted Thoracic Surgery (VATS) - The SEAVATS Study	NCT02359175	Lung Neoplasms Pain Immune Suppress...	Bupivacaine in ... Fentanyl in epi... Placebo (for Bu... Oral Paracetamo... Oral NSAID Oral opioids Placebo (for or...	18 Years -	Odense University Hospital
Supplementary Epidural Analgesia in Video-Assisted Thoracic Surgery (VATS) - The SEAVATS Study	NCT02359175	Lung Neoplasms Pain Immune Suppress...	Bupivacaine in ... Fentanyl in epi... Placebo (for Bu... Oral Paracetamo... Oral NSAID Oral opioids Placebo (for or...	18 Years -	Odense University Hospital
A New Anatomical Classification of Portal Vein Location of Pancreas Tumors	NCT04416685	Pancreatic Neop...	primary repair segmental resec... graft reconstru...	18 Years -	Sisli Hamidiye Etfal Training and Research Hospital

Spots Global Cancer Trial Database for segmental resection