Symptoms and General Pathology

All Conditions

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Body Weight

Mediastinal Neoplasms

Thoracic Neoplasms

Mediastinal Diseases

Thoracic Diseases

Respiratory Tract Diseases

using MRI diffusion to differentiate between benign and malignant mediastinal masses

MRI diffusion

Noha Mohammed Ali Attia, lecturer

Mostafa Thabet Hussein, professor

Differentiation between benign and malignant mediastinal tumors as well as characterization and grading of malignancy which is essential for treatment planning as well as for prognosis

Differentiation between benign and malignant mediastinal tumors as well as characterization and grading of malignancy is essential for treatment planning as well as for prognosis .

MRI presents valuable diagnostic information in assessing the mediastinum. In addition, special applications have been developed over recent years diffusion-weighted magnetic resonance imaging is one such technique The advent of echo-planar imaging technique has rendered diffusion weighted imaging of the abdomen and thoracic cavity possible .

Quantitative assessment of the mediastinal mass is possible by calculation of apparent diffusion co-efficient value ,which is related to the proportion of extracellular and intracellular component.

The apparent diffusion co-efficient is inversely correlated with tissue cellularity. It is lower in viable tumor tissue with densely packed diffusion-hindering obstacles than in tissue with less densely packed obstacles such as tumor necrosis and benign tissue .

Assessment of Mediastinal Masses With Diffusion Weighted MR Imaging

Assiut University

Principal Investigator

Lung Neoplasms

Lung Diseases

Respiratory Tract Neoplasms

Thoracoscopic surgery performed with the fashion of single 2.5-3.5 cm intercostal incision and 1-2 additional 2-3 mmm needlescopic ports.

Conventional uniportal VATS with single 2.5-3.5 cm intercostal incision

Video-assisted thoracoscopic surgery for pulmonary or mediastinal lesions.

Thoracoscopic surgery

Chiu-kuei Nien

The investigators' study aims is to evaluate the safety and efficacy of uniportal VATS under assistance of needlescopic instruments through additional 2-3 mm ports compared to conventional uniportal VATS in patients with lung lesions.

Needlescopic-assisted Uniportal vs Uniportal VATS

Needlescopic-assisted Uniportal VATS Versus Conventional Uniportal VATS. A Randomized Prospective Noninferiority Study

Post-operative day 3 pain scale documented using Visual Analogue Scale (VAS)

Post-operative day 5 pain scale documented using Visual Analogue Scale (VAS)

Out patient documented using PainDETECT questionnaire (PD-Q)

Total opioid equivalent dose used during post-operative course

IRB of NTUH Hsin-Chu Branch

National Taiwan University Hospital Hsin-Chu Branch

Nervous System Diseases

Immune System Diseases

Blood and Lymph Conditions

Rare Diseases

Myasthenia Gravis

Thymoma

Thymus Neoplasms

Syndrome

Paraneoplastic Syndromes

Paraneoplastic Syndromes, Nervous System

Nervous System Neoplasms

Autoimmune Diseases

Autoimmune Diseases of the Nervous System

Neurodegenerative Diseases

Neuromuscular Junction Diseases

Neuromuscular Diseases

Neoplasms by Histologic Type

Lymphatic Diseases

The patients in subxiphoid group will get subxiphoid approach extended thymectomy by VATS. Whole dissection was performed through a 4 to 7cm transverse subxiphoid incision, and a single 5-mm port was inserted into the right chest cavity for the video thoracoscope and subsequently for the chest tube. The sternum was elevated with two hooks connected to the sternal frame. The lower hook was inserted through the subxiphoid incision, and the superior hook was inserted percutaneously after the mediastinal tissue including the major mediastinal vessels was dissected from the inner surface of the sternum. The thymus and fatty tissue of the anterior mediastinum and the aorta-pulmonary window was completely removed.

The patients in intercostal group will get intercostal approach extended thymectomy by VATS.

Extended thymectomy performed through the subxiphoid-right VATS approach with double elevation of the sternum

Subxiphoid approach extended thymectomy by VATS

Extended thymectomy performed through the traditional intercostal VATS approach

Intercostal approach extended thymectomy by VATS

Jiang Fan, MD，PhD

Nan Song, MD

Biao Li, MD

Jiang Fan, MD

Wenxin He, MD

Liang Duan, MD

Tao Ge, MD

Hao Li, MD

Rongsheng Zhang, MD

Xiaobing Li, MD

Xuelin Zhang, MD

Extended thymectomy is the main treatment for thymoma and other anterior mediastinal diseases. Video-assisted thoracic surgery(VATS) plays an important role in the surgery of extended thymectomy. Now, VATS thymectomy through intercostal approach has been the commonly used minimally invasive surgical procedure for thymus surgery and is applied worldwide. But the intercostal approach may cause residue of thymus tissue and chronic pain. In 2013, doctor Marcin Zielin´ski form Poland reported a new technique of minimally invasive extended thymectomy performed through the VATS approach with double elevation of the sternum. And their early results proved this technique is probably the least invasive and the most complete technique of VATS thymectomy with excellent cosmetic results. Until now, doctor Jiang Fan form Shanghai Pulmonary Hospital has performed 50 cases extended thymectomy through the subxiphoid approach with double elevation of the sternum by VATS. This study is designed to compare the curative effect between this new method and traditional intercostal VATS.

This study is a prospective multicentre cohort study.The main study content is comparative study of the curative effect of extended thymectomy performed through the subxiphoid-right video-thoracoscopic approach with double elevation of the sternum versus intercostal video-thoracoscopic approach, divided into subxiphoid and intercostal groups. Communicating with the surgeon and patients who meet the inclusion criteria, decide whether to enter the subxiphoid or intercostal group. Subxiphoid group with subxiphoid-right video-thoracoscopic approach under double elevation of the sternum in extended thymectomy , intercostal group with traditional intercostal video-assisted thoracoscopic surgery in extended thymectomy. By collecting personal information of two groups of patients and the corresponding observation indicators to analyze whether the subxiphoid-right VATS approach with double elevation of the sternum is the least invasive and the most complete technique of VATS thymectomy.

This study is a prospective multicentre cohort study.The main study content is comparative study of the curative effect of extended thymectomy performed through the subxiphoid-right video-thoracoscopic approach with double elevation of the sternum versus intercostal video-thoracoscopic approach, divided into subxiphoid and intercostal groups. Communicating with the surgeon and patients who meet the inclusion criteria, decide whether to enter the subxiphoid or intercostal group. Subxiphoid group with subxiphoid-right video-thoracoscopic approach under double elevation of the sternum in extended thymectomy , intercostal group with traditional intercostal video-assisted thoracoscopic surgery in extended thymectomy.

The Curative Effect of Extended Thymectomy Performed Through Subxiphoid-right VATS Approach With Elevation of Sternum

A Prospective Multicenter Comparative Study of the Curative Effect of Extended Thymectomy Performed Through the Subxiphoid VATS Approach With Double Elevation of the Sternum Versus Intercostal VATS Approach

The thymus tissue resection rate was calculated by comparing the preoperative and postoperative CT images.

Visual analogue score (VAS-score) is to asses the development of acute pain after surgery. 11 point numeric rating scale of 0 represented "no pain"and a score of 10 represented "worst pain " in patients 24 hours after operation.

The EuroQol 5 Dimensions (EQ-5D) is used. EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. EQ-5D includes self-reported quality of life, where 0 is the worst and 100 is the best imaginable health state.

The Quantitative Myasthenia Gravis scale (QMG) is used. It includes 13 items, such as eyelid ptosis, diplopia, eyelid closure, speech, swallowing, vital capacity, lift, grip and lower extremity elevation. QMG can evaluate myasthenia, and total score of the scale is from 0 (no myasthenia) to 39 (the most severe myasthenia). If the difference between the two assessment scores is greater than 3.5, it is considered that the symptoms of myasthenia gravis relieved.

From grouping to the recurrence of disease or the time of death due to disease progression.

The rate of patients recurrence after surgery

Death caused by operation or complications

The incidence rate of postoperative complications in the two groups

Visual analogue score (VAS-score) is to asses the development of chronic pain after surgery. 11 point numeric rating scale of 0 represented "no pain"and a score of 10 represented "worst pain " in patients 6 months after operation.

Jiang Fan

Chief physician

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nutritional and Metabolic Diseases

Prostatic Neoplasms

Obesity

Hernia

Prolapse

Pelvic Organ Prolapse

Obesity, Morbid

Genital Diseases, Female

Hernia, Inguinal

Hernia, Ventral

Prostatic Diseases

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Pathological Conditions, Anatomical

Hernia, Abdominal

Overweight

Overnutrition

Nutrition Disorders

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Subjects scheduled to undergo robotic-assisted surgery

Robotic-assisted Surgery

This prospective, multicenter, single-arm study is being conducted to confirm safety, effectiveness, and usability of da Vinci Surgical System in performing robotic-assisted surgical procedures.

Clinical Investigation of the da Vinci Surgical System

A Prospective, Multicenter Clinical Investigation of the da Vinci Surgical System

Effectiveness defined as the ability to complete the planned da Vinci robotic-assisted procedures without conversion to open.

Safety defined as the incidence of all intra-operative and post-operative adverse events that occur through the 30-day follow-up period.

Intuitive Surgical

Patients will receive Adaptive Radiotherapy on the MR-Linac treatment machine.

The radiotherapy was delivered using the Unity-based MR-Linac treatment machine.

Unity-based MR-Linac guided Radiotherapy

Daquan Wang, M.D

Bo Qiu, M.D

Hui Liu, Prof.

Hui Liu

This Phase II study is to determine the efficacy and safety of MR-Linac Guided Radiotherapy in patients with inoperable mediastinal tumors.

This Phase II study is to determine the efficacy and safety of MR-Linac Guided Radiotherapy in patients with inoperable mediastinal tumors.

Patients will receive radiotherapy on the MR-Linac treatment machine. The primary end point is 2-year local-recurrence free survival. The secondary end points are objective response rate, 2-y PFS, 2-y OS, safety of treatment, dose coverage of targets and dose to normal organs.

MR-linac Guided Adaptive Radiotherapy for Inoperable Mediastinal Tumor

A Prospective, Phase II Study of MR-Linac Guided Adaptive Radiotherapy for Inoperable Mediastinal Tumor

Sun Yat-sen University

Professor

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

This group of patients underwent TNT uniportal VATS mediastinal tumor resection

This group of patients underwent traditional uniportal VATS mediastinal tumor resection

TNT uniportal video-assisted thoracoscopic surgery refers to the use of conventional uniportal video-assisted thoracoscopic surgery, the use of laryngeal mask anesthesia instead of tracheal intubation anesthesia, intraoperative catheter was not retained, postoperative chest catheter placement.

TNT uniportal VATS mediastinal tumor resection

The surgical procedures followed principles of mediastinal tumor resection，uniportal video-assisted thoracoscopic surgery in mediastinal tumor resection.

Traditional uniportal VATS mediastinal tumor resection

TNT surgery is a new area of exploration and evolution in thoracic minimal invasive surgery. TNT Uniportal Video-assisted Thoracoscopic Surgery (VATS) has become popular during mediastinal tumors resection. However, there has been little randomized controlled trials into the associated feasibility and advantage. The aim of our RCT was to evaluate the feasibility and advantage of TNT Uniportal VATS for mediastinal tumors resection and its significance in Fast Track Surgery (FTS). This is a single-center prospective randomized controlled trial. 98 patients aged between 18 and 75 years with clinically mediastinal tumors were randomly assigned to two groups, 50 patients received TNT uniportal VATS mediastinal tumor resection (TNT group) and 48 patients underwent traditional uniportal VATS mediastinal tumor resection (control group), the short-term perioperative outcomes would be reported here.

This study was designed as a single-center prospective randomized controlled trial. The trial recruited patients aged from 18 to 75 years with a diagnosis of mediastinal tumor. Preoperative chest CT examination showed that shape of the mediastinal tumor was regular, boundary was clear, and maximum diameter of the mass was less than 4 cm. Other inclusion criteria included capability of giving consent and adequate organ function to tolerate uniportal thoracoscopy mediastinal tumor resection. The exclusion criteria are described as follows: preoperative examination showed that the tumor invaded the surrounding blood vessels, pericardium, lung and other tissues or had distant metastasis; preoperative complications include severe coronary heart disease, arrhythmia and other serious cardiopulmonary diseases; large masses, difficult surgical procedures; manifestations of myasthenia gravis; hypovolemia, blood disorders, or abnormal clotting mechanism; pulmonary function and arterial blood gas analysis showed that patients could not tolerate surgery; previous thoracotomy; inability to obtain consent. Furthermore, the exclusion criteria were defifined as follows: intraoperative pleural adhesion or technical challenge to achieve hemostasis that make conversion from VATS to thoracotomy; clinician decides the patient should not continue the trial according to individual condition; patient withdraws from the trial. According to International Conference on Harmonisation, all participants gave written informed consent. Our RCT was launched in April 2018, which conducted in accordance with the Declaration of Helsinki and good clinical practice according to the International Conference on Harmonization guidelines. The ethics committee of The Fourth Affiliated Hospital of Medical Sciences, Liaoning, China, approved this study (approval number: EC-2018-HS-01).

After eligibility had been confirmed and inform consents obtained, the investigator registered patients to ensure allocation concealment. Next we randomly enrolled patients to TNT group and control group in accordance with a list of randomization numbers. This list was generated in the trial statistician's computer. Allocation was communicated by telephone by the trial coordinator. Neither patients nor any investigators were masked to treatment allocation.

The patients underwent routine physical examination, hematologic and biochemical tests, arterial blood gas analysis, pulmonary function test and computed tomography. Uniportal VATS mediastinal tumor resection was the standard surgical intervention according to the protocol. Patients in TNT group underwent TNT uniportal VATS mediastinal tumor resection, patients in control group underwent traditional uniportal VATS. Pre-, peri-, and postoperative details and outcome variables of patients were collected.

This is a single-center prospective randomized controlled trial. 98 patients aged between 18 and 75 years with clinically mediastinal tumors were randomly assigned to two groups, 50 patients received TNT uniportal VATS mediastinal tumor resection (TNT group) and 48 patients underwent traditional uniportal VATS mediastinal tumor resection (control group), the short-term perioperative outcomes would be reported here.

This study is a prospective randomized controlled clinical trial. Participants, care provider, and investigator all know the grouping situation. The Investigator collect the information and observation indicators of the two groups of participants and send to the Outcomes Assessor . The Outcomes Assessor does not know the grouping situation of each participant.

Totally no Tube (TNT) Uniportal Video-assisted Thoracoscopic Surgery (VATS) VS Traditional Uniportal VATS for Mediastinal Tumor

Totally no Tube (TNT) Uniportal Video-assisted Thoracoscopic Surgery (VATS) VS Traditional Uniportal VATS for Mediastinal Tumor: A Prospective Randomized Controlled Trial

Anesthesia completed to the end of the operation

Intubation/laryngeal mask completion time

The VAS pain score was given to patients and the pain scores were recorded at 6h, 12h, 24h, 48h, and 72h postoperatively.

The time from the patient's postoperative pushback to the first bedtime

Intraoperative mean arterial pressure, MAP

Incidence of postoperative complications such as respiratory, cardiovascular and intubation-related complications

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Assessment of Mediastinal Masses With Diffusion Weighted MR Imaging	NCT03214341	Mediastinal Tum...	MRI diffusion	-	Assiut University
Needlescopic-assisted Uniportal vs Uniportal VATS	NCT03439696	Lung Cancer Lung Cancer Met... Bullous Disease... Nodule Solitary... Mediastinal Tum...	Thoracoscopic s...	20 Years - 90 Years	National Taiwan University Hospital Hsin-Chu Branch
The Curative Effect of Extended Thymectomy Performed Through Subxiphoid-right VATS Approach With Elevation of Sternum	NCT03613272	Thymoma Myasthenia Grav... Mediastinal Tum...	Subxiphoid appr... Intercostal app...	20 Years - 70 Years	Tongji University
Clinical Investigation of the da Vinci Surgical System	NCT05682742	Thymoma Mediastinal Tum... Gynecologic Dis... Gynecologic Can... Pelvic Organ Pr... Prostate Diseas... Prostate Cancer Inguinal Hernia Ventral Hernia Obesity, Morbid	Robotic-assiste...	21 Years -	Intuitive Surgical
MR-linac Guided Adaptive Radiotherapy for Inoperable Mediastinal Tumor	NCT05163509	Mediastinal Tum...	Unity-based MR-...	18 Years - 75 Years	Sun Yat-sen University
The Curative Effect of Extended Thymectomy Performed Through Subxiphoid-right VATS Approach With Elevation of Sternum	NCT03613272	Thymoma Myasthenia Grav... Mediastinal Tum...	Subxiphoid appr... Intercostal app...	20 Years - 70 Years	Tongji University
Needlescopic-assisted Uniportal vs Uniportal VATS	NCT03439696	Lung Cancer Lung Cancer Met... Bullous Disease... Nodule Solitary... Mediastinal Tum...	Thoracoscopic s...	20 Years - 90 Years	National Taiwan University Hospital Hsin-Chu Branch
Totally no Tube (TNT) Uniportal Video-assisted Thoracoscopic Surgery (VATS) VS Traditional Uniportal VATS for Mediastinal Tumor	NCT03537430	Mediastinal Tum...	TNT uniportal V... Traditional uni...	18 Years - 75 Years	Shengjing Hospital
Assessment of Mediastinal Masses With Diffusion Weighted MR Imaging	NCT03214341	Mediastinal Tum...	MRI diffusion	-	Assiut University
Totally no Tube (TNT) Uniportal Video-assisted Thoracoscopic Surgery (VATS) VS Traditional Uniportal VATS for Mediastinal Tumor	NCT03537430	Mediastinal Tum...	TNT uniportal V... Traditional uni...	18 Years - 75 Years	Shengjing Hospital

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