Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Uniportal lobectomy with complete lymphadenectomy - transcervical approach with elevation of the sternum

Uniportal lobectomy with complete lymphadenectomy - intercostal approache

uniportal lobectomy with complete lymphadenectomy

Marcin Zielinski, MD PhD

Marcin Zielinski

Marcin Zielinski, MD Phd

Michal Wilkojc

Aim of the study is to compare safety and tolerance of two techniques of Video Assisted Thoracic Surgery (VATS) uniportal lobectomies in the prospective randomized single-institutional trial. One arm is a uniportal lobectomy performed through the transcervical approach with elevation of the sternum, the other arm will utilize a standard uniportal intercostal approache. There will be 10 patients in each group. Patients in clinical stage cI-III (T1-3N0-2M0) Non-Small Cell Lung Cancer (NSCLC). The results will be compared for time of the procedure, number of conversions to multi-portal VATS and/or open thoracotomy, duration and volume of chest drainage, amount of postoperatve pain, time of hospitalization and the number of resected lymph nodes and metastatic nodes. Accrual of patients is planned to complete within 12 months.

Introduction Video-assisted thoracoscopic surgery (VATS) pulmonary lobectomy became an accepted method for the treatment of early-stage Non-Small-Cell Lung Cancer (NSCLC). There are several variants of VATS lobectomy. In recent years the uniportal approach described by Gonzales-Rivas gained a world-wide interest. The uniportal VATS approach can be performed through the intercostal incision as has been practiced in vast majority of published cases, but there is also another approach, namely the transcervical one, first described by Zakopane team in 2007. In that time, right upper lobectomy and afterwards the left upper lobectomy through the transcervical approach combined with single-port intercostal VATS were performed. The method was to combine lobectomy with Transcervical Extended Mediastinal Lymphadenectomy (TEMLA), preceding a pulmonary resection with intraoperative examination of the mediastinal nodes with the imprint cytology technique. From 2016, after adopting the technique of uniportal intercostal lobectomy, transcervical VATS uniportal lobectomies, without additional intercostal ports were performed. Now, resection of any rightsided or left-sided lobe with the transcervical approach are feasible to be performed.

Surgical Technique Preparation The patient is positioned supine on the operating table with a roll placed beneath the thoracic spine to elevate the chest and to hyperextend the patient's neck. Under general anaesthesia an endobronchial tube is inserted to conduct selective lung ventilation during the latter part of the procedure.

A transverse 6-8 cm transcervical collar incision is made in the neck in a standard way with division and suture-ligation of the anterior jugular veins bilaterally. The sternal manubrium is elevated with sharp one-tooth hook connected to the Zakopane II frame (Aesculap-Chifa, BBraun, Nowy Tomysl, Poland) to widen the access to the mediastinum. The first part of the procedure is TEMLA. The technique of this procedure, and possible pitfalls and the methods of management of intraoperative complications were published elsewhere \[6\]. In brief, the technique of TEMLA included dissection of all mediastinal nodal stations except for the pulmonary ligaments nodes (station 9). The subcarinal nodes, the periesophageal nodes, the right and left lower paratracheal nodes, and the right hilar nodes (stations 7, 8, 4R, 4L and 10R) were removed in the mediastinoscopy-assisted technique and the paraaortic and the pulmonary-window nodes (stations 6 and 5) are removed in the videothoracoscopy-assisted technique, with the videothoracoscope inserted through the transcervical incision. The superior mediastnal nodes and upper right and left paratracheal nodes (stations 1, 2R and 2L) are removed in the open surgery fashion under direct eye control. The prevascular and retrotracheal nodes (stations 3A and 3P) are removed in pre-selective cases. Generally, the mediastinal pleura is not violated and no drain is left in the mediastinum. Bilateral supraclavicular lymphadenectomy and even deep cervical lymph node dissection is possible during TEMLA through the same incision.

The nodes removed during TEMLA are sent sequentially to intraoperative pathologic examination with use of the imprint cytology technique \[4\]. The imprint cytology technique is a highly reliable technique much less time consuming than a frozen section analysis. Due to this advantage the time of nodal examinations adds only 15 to 20 minutes to the total time of the operation. After receiving the negative results of the imprint cytology, confirming there are no nodal metastasis the VATS lobectomy part starts. The position of the patient is slightly changed with the introduction of the roll beneath the patient's operating side. Additionally, the operating table is rotated to achieve a semi-lateral position of the patient. The ventillation of the operated lung is disconnected and the mediastinal pleura is opened. Further dissection is performed with the use of endostaplers to manage the lobar vesselts, bronchus and interlobar fissures.

Comparison of Two Techniques of Uniportal VATS Lobectomies for Clinical Stage I Non-Small Cell Lung Cancer

Comparison of Two Techniques of Video Assisted Thoracic Surgery (VATS) Uniportal Lobectomies Through the Transcervical and Standard Intercostal Approaches for Clinical Stage I Non-Small Cell Lung Cancer (NSCLC) in the Prospective Randomized Single-institutional Trial

number of conversions to multi-portal VATS and/or open thoracotomy

1.pain intensity 0-100 mm VAS scale measured every 4 hours on standard ruler beginning from the end of the surgery.

The visual analogue scale (VAS) is commonly used as the outcome measure for such studies. It is usually presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable." Its simplicity, reliability, and validity, as well as its ratio scale properties, make the VAS the optimal tool for describing pain severity or intensity.

Pulmonary Hospital Zakopane

Behaviors and Mental Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Quality of Life

The patients will fulfill the EORTC-LC29 and HADS questionnaires in 5 different moments.

Questionnaires

Pablo Fernández Salvador, Nurse

Nuria M Novoa Valentín, MD, PhD

Marta G Fuentes Gago, MD, PhD

María B García Cenador, MD, PhD

The goal of this prospective, observational study is to measure and analyze the effect of adjuvant treatment over the quality of life and recovery of patients undergoing pulmonary resection because of non-small cells lung cancer using the EORTC-LC29 questionnaire. The main question it aims to answer is:

Whether adjuvant systemic treatment affect or not the postoperative QOL of a NSCLC patient that underwent lung resection

Participants will fulfill two questionnaires (EORTC-LC29 and Hospital Anxiety and Depression Scale) in different stages of their treatment.

Despite being surgery the preferred radical treatment of NSCLC in early stages, unforseen N2 disease, larger tumors or bad prognosis histological or molecular findings of the tumor will benefit of receiving adjuvant treatment.

As an adjuvant treatment, postoperative platinum-based chemotherapy has demonstrated its efficacy in increasing survival rates and reducing recurrence rates. Postoperative radiotherapy (RT) is limited due to decreased lung tolerance following surgery and conflicting results.

It is clear that lung cancer significantly impacts the quality of life of patients. According to the Lung Cancer Europe (LuCE) association, a survey conducted in 2021 with 515 patients revealed that 91.2% experienced limitations in their daily lives. Fatigue, sleep problems, cognitive difficulties, and significant reductions in physical activity were the main areas where patients reported the most complications. In addition to the inherent complications of cancer, we must consider the complications associated with surgery and systemic treatment.

Module LC29 is an update of the previous module published by the European Organisation for Research and Treatment of Cancer (EORTC), providing a more current perspective on lung cancer. This latest module retains 12 out of the 13 items from LC13 and adds 17 new items, which gather information on the side effects of medical and targeted therapies, as well as emotional problems. Furthermore, it includes 5 specific questions related to lung surgery. This multidisciplinary approach currently makes the LC29 questionnaire the most comprehensive tool for studying the quality of life of lung cancer patients.

QOL After SURGERY and ADJUVANT Treatment

Evaluation of Changes in Quality of Life in Patients With Non-small Cell Lung Carcinoma Undergoing Lung Resection Before and After Receiving Adjuvant Treatment Using the EORTC-LC29 Questionnaire

For quality of life assessment, patients will be asked to complete the Quality of Life Questionnaire Module LC29 (QLQ-LC29) of the European Organization for Research and Treatment of Cancer (EORTC).

Measure and analyze the correlation between the type of surgical procedure performed and postoperative quality of life upon completion of the surgical episode and before receiving any form of adjuvant treatment for lung cancer. Patients will be asked to complete the Quality of Life Questionnaire Module LC29 (QLQ-LC29) of the European Organization for Research and Treatment of Cancer (EORTC). The type of surgical procedure (segmentectomy, lobectomy or pneumonectomy), will be collected from the post-surgery report.

Measure and analyze the correlation between the type of surgical approach performed and postoperative quality of life upon completion of the surgical episode and before receiving any form of adjuvant treatment for lung cancer. Patients will be asked to complete the Quality of Life Questionnaire Module LC29 (QLQ-LC29) of the European Organization for Research and Treatment of Cancer (EORTC). The type of surgical approach (thoracotomy, VATS or RATS), will be collected from the post-surgery report.

Analyze the correlation between the occurrence of postoperative complications and a longer hospital stay with the quality of life before receiving any form of adjuvant treatment for lung cancer. Patients will be asked to complete the Quality of Life Questionnaire Module LC29 (QLQ-LC29) of the European Organization for Research and Treatment of Cancer (EORTC). Post-surgery complications will be collected from the patient's medical record, recorded in the Jimena 4 software program. Hospital stay lenght will be collected from the patient´s hospital discharge report.

Measure and analyze the effect of complications from adjuvant treatment on the surgical items of the EORTC-LC29 for patients undergoing lung resection for lung cancer. Patients will be asked to complete the Quality of Life Questionnaire Module LC29 (QLQ-LC29) of the European Organization for Research and Treatment of Cancer (EORTC), where higher score represents higher level of symptomatology or problems.

Measure and analyze whether any adjuvant chemotherapy/immunotherapy treatment regimen significantly decreases the quality of life of patients who receive adjuvant treatment after undergoing lung resection compared to others.

Analyze the correlation between the presence of Chronic Obstructive Pulmonary Disease (COPD) and postoperative quality of life upon completion of the surgical episode before and after receiving any form of adjuvant treatment for lung cancer. Patients will be asked to complete the Quality of Life Questionnaire Module LC29 (QLQ-LC29) of the European Organization for Research and Treatment of Cancer (EORTC).

Measure and analyze the level of anxiety/depression in patients undergoing lung resection before and after receiving the first cycle of adjuvant treatment for lung cancer. Patients will be asked to complete the HADS questionnaire.

Measure and analyze the effect of Performance Status (PS) and pre-adjuvant treatment ECOG on the quality of life after receiving the first cycle of any treatment modality. Patients will be asked to complete the Quality of Life Questionnaire Module LC29 (QLQ-LC29) of the European Organization for Research and Treatment of Cancer (EORTC). Performance Status Score and ECOG score data will be collected from the patient's medical record, recorded in the Jimena 4 software program.

University of Salamanca

Principal Investigator

Pharmaceutical Solutions

All Drugs and Chemicals

Antineoplastic Agents

Altretamine

Standard surgical closure (suturing or stapling of visible air leaks incurred during resection of lung parenchyma) plus Progel Pleural Air Leak Sealant.

Progel Pleural Air Leak Sealant without standard surgical closure (without suturing or stapling of visible air leaks incurred during resection of lung parenchyma).

Standard surgical techniques including staples and sutures.

Control

ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG). Standard closure means, for example, suturing or stapling of visible air leaks incurred during resection of lung parenchyma.

ProGEL Pleural Air Leak Sealant with standard surgical closure

ProGEL Pleural Air Leak Sealant without standard surgical closure

Robert J. Cerfolio, MD

Daniel L. Miller, MD

The purpose of this post approval study is to further characterize the safety profile of the ProGEL™ Pleural Air Leak Sealant in commercial use, with specific reference to long-term safety over 90 days of follow-up.

Patients having open thoracotomy involving lung resection surgery will be considered for the study. Subjects will be examined for adverse events and complications from either the treatment or the procedure. Follow-up visits are required at 30 days and 90 days after the surgery.

NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study

AirTight: A Prospective Controlled Post-Approval Study of NeoMend ProGEL™ Pleural Air Leak Sealant in the Treatment of Visible Pleural Air Leaks After Standard Pleural Closure

* Pulmonary adverse events: pneumothorax, persistent air leak, late onset air leak, residual pleural space, and acute respiratory distress syndrome
* Renal adverse events
* Cardiac adverse events
* Death (all causes)
* Hospital readmission

C. R. Bard

No treatment.

Control: Standard surgical techniques including staples and sutures.

ProGEL Pleural Air Leak Sealant: ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG).

Standard surgical closure (standard closure with, sutures or staples, for example) plus Progel Pleural Air Leak Sealant.

ProGEL Pleural Air Leak Sealant With Standard Surgical Closure

ProGEL Pleural Air Leak Sealant: ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG).

Progel Pleural Air Leak Sealant without standard surgical closure (standard closure with, sutures or staples, for example).

ProGEL Pleural Air Leak Sealant Without Standard Surgical Closure

ProGEL Pleural Air Leak Sealant: ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG).

Standard closure, for example, by suturing or stapling, of visible air leaks incurred during resection of lung parenchyma.

ProGEL Pleural Air Leak Sealant: ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG).

Without standard closure, for example, suturing or stapling, of visible air leaks incurred during resection of lung parenchyma.

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race/Ethnicity

Race/Ethnicity, Customized

United States

Region of Enrollment

Height

Weight

Body Mass Index (BMI)

Dawn Heimer, PhD

Standard surgical technique plus Progel Pleural Air Leak Sealant.

ProGEL Pleural Air Leak Sealant: ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG).

ProGEL Pleural Air Leak Sealant

Units analyzed represents the number of adverse events that occurred among all study participants in each arm.

Also, the original Protocol was designed to study ProGel (any usage) versus no ProGel. After the study was completed, the FDA requested that the ProGel group be broken out by patients with standard closure, and without.

Safety Endpoints

Overall Study

Anxiety Disorders

Depression

Depressive Disorder

Behavioral Symptoms

questionnaires

The interest of pulmonary rehabilitation for patients who underwent lung resection for cancer remains controversial. The investigators studied the effects of the RR and its impact on quality of life and level of anxiety and depression in patients.

In 2011 and 2012 , an RR was proposed to the patients referred to our center after lung resection for cancer. Patients were assessed at entry and departure by 6minutes walk test , a visual analog pain scale , a quality of life questionnaire ( EORTC QLQ C30 ) and an anxiety questionnaire and Depression (HAD) . These same questionnaires were mailed 6 months after the end of the pulmonary rehabilitation .

Impact of Pulmonary Rehabilitation After Lung Resection for Cancer on Patients' Level of Anxiety and Depression

Assess the level of depression during and after a respiratory rehabilitation training in institutions

Assess the level of anxiety during and after a respiratory rehabilitation training in institutions

Centre Hospitalier Universitaire de Nice

Duet TRS

Hiran C Fernando, MD

The objectives of this clinical trial are to estimate the incidence and duration of air leaks and the incidence of prolonged air leaks (defined as \> 5 days by the Society for Thoracic Surgery) when using the ENDO GIA Staplers with ENDO GIA Single Use Loading Units (SULUs) buttressed with Duet TRS TM in an anatomic pulmonary resection via Video Assisted Thoracoscopic Surgery (VATS). Anatomic pulmonary resection is defined as either a lobectomy or segmental resection. Results of the study will be compared to contemporary literature for a similar population.

Duet TRS Used in Pulmonary Resections

A Prospective, Multi-Center Evaluation of Endo GIA Staplers With Endo GIA Single Use Loading Units (SULUs) With Duet TRS TM in a Pulmonary Resection

Medtronic - MITG

Stephanie Marcucio, Senior Clinical Research Associate

Symptoms and General Pathology

Wounds and Injuries

Ischemia

Lung Injury

Thoracic Injuries

Central Nervous System Depressants

Anesthetics

Adult patients undergoing elective pulmonary lobectomy were received a remote ischemic preconditioning group after induction of anaesthesia.

Adult patients undergoing pulmonary lobectomy were received no treatment after induction of anaesthesia.

Remote ischaemic preconditioning consisted of three 5-min cycles of right upper limb ischaemia, induced by an automated cuff-inflator placed on the upper arm and inflated to 200 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated.

remote ischemic preconditioning

Xuan Ke Liu, Ph.d

The purpose of this study is to determine whether ischemic preconditioning reduces lung injury in patients undergoing pulmonary resection.

Remote ischemic preconditioning is an intervention in which brief ischemia of one tissue or organ protects remote organs from a sustained episode of ischemia. It is known that one-lung ventilation in patients undergoing pulmonary resection, which may cause acute lung injury. The investigators did a single-blinded randomised controlled study to establish whether remote ischemic preconditioning reduces lung injury in these patients.

Effect of Remote Ischemic Preconditioning on Lung Injury After Pulmonary Resection

Effect of Remote Ischemic Preconditioning on Lung Injury in Patients Undergoing Pulmonary Resection:a Randomised Controlled Trial

PaO2/FiO2 in the limb RIPC group was significantly higher than that in the control group at 30 and 60 min after OLV, 30 min and 6 h after operation (all P\<0.05)

Cs and Cd in limb RIPC group were significantly higher than those in the control group at 30 and 60 min after OLV (all P\<0.05)

The IL-6 levels in the limb RIPC group were lower than those in the control group at 30 min, 6, 12, 24 and 48 h after operation (all P\<0.05), and there was a significant difference in TNF-α level between the groups (P\<0.01).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Two Techniques of Uniportal VATS Lobectomies for Clinical Stage I Non-Small Cell Lung Cancer	NCT03997799	Video Assisted ... Non-Small Cell ...	uniportal lobec...	18 Years - 85 Years	Pulmonary Hospital Zakopane
QOL After SURGERY and ADJUVANT Treatment	NCT06115239	Carcinoma, Non-... Quality of Life	Questionnaires	50 Years - 85 Years	University of Salamanca
NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study	NCT01394978	Lung Cancer Lung Tumor	Control ProGEL Pleural ... ProGEL Pleural ...	18 Years -	C. R. Bard
Impact of Pulmonary Rehabilitation After Lung Resection for Cancer on Patients' Level of Anxiety and Depression	NCT04985474	Pulmonary Resec...	questionnaires	-	Centre Hospitalier Universitaire de Nice
Duet TRS Used in Pulmonary Resections	NCT01026025	Lung Cancer	Duet TRS	18 Years -	Medtronic - MITG
Duet TRS Used in Pulmonary Resections	NCT01026025	Lung Cancer	Duet TRS	18 Years -	Medtronic - MITG
Comparison of Two Techniques of Uniportal VATS Lobectomies for Clinical Stage I Non-Small Cell Lung Cancer	NCT03997799	Video Assisted ... Non-Small Cell ...	uniportal lobec...	18 Years - 85 Years	Pulmonary Hospital Zakopane
Effect of Remote Ischemic Preconditioning on Lung Injury After Pulmonary Resection	NCT01307085	Lung Neoplasms	remote ischemic...	18 Years - 65 Years	First Affiliated Hospital, Sun Yat-Sen University

Spots Global Cancer Trial Database for pulmonary resection