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Robot-assisted vs VATS for Thymoma

Primary Purpose

Thymoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
RATS for Thymectomy
VATS for Thymectomy
Sponsored by
Shanghai Pulmonary Hospital, Shanghai, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thymoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ) The age of the subjects on the day of signing the informed consent was ≥ 18 years old and < 75 years old, regardless of gender ; ) Chest thin-layer CT and MR showed anterior mediastinal space-occupying lesions, combined with relevant hematological indicators, the patient was clinically diagnosed as a thymic epithelial tumor with or without myasthenia gravis ( MG ) symptoms. ) need to accept thymectomy surgery ; ) Clinical stage I to IIIA ( AJCC-UICC TNM staging system ) ; ) The maximum diameter of the lesion < 5cm ; ) physical condition score 0 or 1 ( Eastern Cooperative Oncology Group ECOG scoring system ) ; ) Have not received any anti-thymoma therapy before, including but not limited to systemic chemotherapy, radiotherapy, etc. ; ) Preoperative major organ function meets the following criteria : Bone marrow function: hemoglobin ≥ 10.0 g / dL ( no blood transfusion within 28 days before hemoglobin examination ), absolute neutrophil count ≥ 1.5 × 109 / L, platelet count ≥ 100 × 109 / L ( no transfusion of apheresis platelets or IL-11 treatment within 14 days before platelet count examination ) ; coagulation function : INR and PT < 1.5 × ULN, APTT ≤ 1.5 × ULN ; liver function: transaminase ( ALT and AST ) ≤ 2.5 × ULN; total bilirubin ≤ 1.5 × ULN ( Gilbert's syndrome or liver metastasis subjects total bilirubin ≤ 2.5 × ULN ) ; renal function: serum creatinine clearance rate ≥ 60 mL/min ( calculated according to the Cockcroft-Gault formula ) ; ) voluntarily participated in and were able to undergo robot-assisted or thoracoscopic thymectomy, and complied with the study follow-up plan. Exclusion Criteria: ) Patients with myasthenia gravis crisis ; ) had undergone mediastinal surgery or cardiac surgery ; ) body mass index ( BMI ) ≥ 30 ; ) Patients with severe liver and kidney dysfunction ( ALT and/or AST more than three times the upper limit of normal, Cr more than the upper limit of normal ) ; ) combined with severe chronic lung diseases such as COPD, asthma, or interstitial lung disease ; ) suffering from uncontrolled heart, kidney, gastrointestinal, and infectious diseases and other complications ; ) patients with other malignant tumors or hematological diseases ; ) combined with chronic pain or preoperative use of opioid analgesics ; ) patients with thoracic deformity or combined with pectus carinatum and pectus excavatum ; ) have mental disorders, such as anxiety disorders ; ) pregnant and/or lactating women ; ) is currently participating in other interventional clinical studies.

Sites / Locations

  • Shanghai Pulmonary Hospital
  • The Second Affiliated Hospital Zhejiang University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RATS for Thymectomy

VATS for Thymectomy

Arm Description

The operator of the surgical incision and the route of entry were determined, and the endoscope and surgical instruments were inserted through the operating hole. The phrenic nerve and diaphragm began to gradually separate upward while avoiding nerve damage. Subsequently, the innominate vein was dissected to observe the branches of the thymus vessels and clamped with a 5 mm Hem-o-Lok clamp. Continue to dissect the left side of the thymus until near the phrenic nerve. After the thymus was removed entirely, it was placed in a bag and removed through an incision. After the operation, a 28 Fr chest tube was placed through the incision to the chest top. An 18 G central venous catheter was placed at the level of the posterior axillary line to the posterior costophrenic angle, and about 10 cm was inserted.

The main operation principles and procedures of the operation are basically similar to those of the RATS and are completed under video-assisted thoracoscopic surgery.

Outcomes

Primary Outcome Measures

5-year overall survival (OS)
OS at 5 year after surgery

Secondary Outcome Measures

Pain score
Pain was assessed using a pain scale on the first day, 1 month, 6 months and 1 year after surgery. Pain was evaluated using the visual analogue scale (VAS) and the numerical rating scale (NRS), with higher scores indicating greater pain
quality of life (QOL) at 1 year by EORTC QLQ-C30
Quality of life was assessed at 1 month, 6 months and 1 year after surgery. QQL was evaluated using the European Organization for the Treatment and Research of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) version 3.0
quality of life (QOL) at 1 year by EQ-5D
Quality of life was assessed at 1 month, 6 months and 1 year after surgery. QQL was evaluated using the European Five Dimensional Health Scale (EQ-5D).
R0 rate
R0 radical rate
operative time
the time of operation
blood loss
blood loss in the operation
conversion rate
the rate of conversion to open surgery in the operation
length of hospital stay (LOS)
length of stay in hospitalization
Catheterization days
The interval days from the completion of catheter insertion to the removal of the thoracic tube
Volume of drainage
Volume of drainage from the completion of catheter insertion to the removal of the thoracic tube
postoperative complications
mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula
30-day mortality
30-day mortality after surgery
30-day readmission rate after surgery
Rate of readmission due to postoperative complications
5-year disease-free survival (DFS)
DFS at 5 year after surgery
Tumor recurrence rate
The rate of recurrence of thymoma in patients after surgery

Full Information

First Posted
August 28, 2023
Last Updated
September 7, 2023
Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
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1. Study Identification

Unique Protocol Identification Number
NCT06029621
Brief Title
Robot-assisted vs VATS for Thymoma
Official Title
Comparison of Short-term and Longterm Outcomes Between Robot-assisted Thoracoscopy and Television-assisted Thoracoscopy Surgery Forthymoma : a Multicenter, Prospective, Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 20, 2023 (Anticipated)
Primary Completion Date
September 19, 2030 (Anticipated)
Study Completion Date
September 19, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Pulmonary Hospital, Shanghai, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of this study is to explore the advantages of robot-assisted thymectomy in long-term survival benefits and short-term clinical efficacy compared with video-assisted thoracoscopic thymectomy based on a multi-center, prospective, randomized controlled clinical trial.
Detailed Description
Video-assisted thoracoscopic surgery ( VATS ) is widely used in thoracic surgery and has gradually replaced traditional thoracotomy in thymoma. As a new type of VATS, the long-term oncological results of robot-assisted thoracoscopic surgery in thymoma have not been verified. Therefore, we designed a multicenter, prospective, randomized controlled clinical trial to determine whether RATS thymectomy is as effective as VATS thymectomy in terms of short-term and long-term outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thymoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RATS versus VATS
Masking
None (Open Label)
Masking Description
no masking
Allocation
Randomized
Enrollment
304 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RATS for Thymectomy
Arm Type
Experimental
Arm Description
The operator of the surgical incision and the route of entry were determined, and the endoscope and surgical instruments were inserted through the operating hole. The phrenic nerve and diaphragm began to gradually separate upward while avoiding nerve damage. Subsequently, the innominate vein was dissected to observe the branches of the thymus vessels and clamped with a 5 mm Hem-o-Lok clamp. Continue to dissect the left side of the thymus until near the phrenic nerve. After the thymus was removed entirely, it was placed in a bag and removed through an incision. After the operation, a 28 Fr chest tube was placed through the incision to the chest top. An 18 G central venous catheter was placed at the level of the posterior axillary line to the posterior costophrenic angle, and about 10 cm was inserted.
Arm Title
VATS for Thymectomy
Arm Type
Active Comparator
Arm Description
The main operation principles and procedures of the operation are basically similar to those of the RATS and are completed under video-assisted thoracoscopic surgery.
Intervention Type
Procedure
Intervention Name(s)
RATS for Thymectomy
Intervention Description
a minimally invasive surgical type for Thymoma: RATS
Intervention Type
Procedure
Intervention Name(s)
VATS for Thymectomy
Intervention Description
a minimally invasive surgical type for Thymoma: VATS
Primary Outcome Measure Information:
Title
5-year overall survival (OS)
Description
OS at 5 year after surgery
Time Frame
5 year after surgery
Secondary Outcome Measure Information:
Title
Pain score
Description
Pain was assessed using a pain scale on the first day, 1 month, 6 months and 1 year after surgery. Pain was evaluated using the visual analogue scale (VAS) and the numerical rating scale (NRS), with higher scores indicating greater pain
Time Frame
at 1 year after surgery
Title
quality of life (QOL) at 1 year by EORTC QLQ-C30
Description
Quality of life was assessed at 1 month, 6 months and 1 year after surgery. QQL was evaluated using the European Organization for the Treatment and Research of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) version 3.0
Time Frame
at 1 year after surgery
Title
quality of life (QOL) at 1 year by EQ-5D
Description
Quality of life was assessed at 1 month, 6 months and 1 year after surgery. QQL was evaluated using the European Five Dimensional Health Scale (EQ-5D).
Time Frame
at 1 year after surgery
Title
R0 rate
Description
R0 radical rate
Time Frame
postoperative in-hospital stay up to 30 days
Title
operative time
Description
the time of operation
Time Frame
Intraoperative
Title
blood loss
Description
blood loss in the operation
Time Frame
Intraoperative
Title
conversion rate
Description
the rate of conversion to open surgery in the operation
Time Frame
Intraoperative
Title
length of hospital stay (LOS)
Description
length of stay in hospitalization
Time Frame
postoperative in-hospital stay up to 30 days
Title
Catheterization days
Description
The interval days from the completion of catheter insertion to the removal of the thoracic tube
Time Frame
postoperative in-hospital stay up to 30 days
Title
Volume of drainage
Description
Volume of drainage from the completion of catheter insertion to the removal of the thoracic tube
Time Frame
postoperative in-hospital stay up to 30 days
Title
postoperative complications
Description
mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula
Time Frame
postoperative in-hospital stay up to 30 days
Title
30-day mortality
Description
30-day mortality after surgery
Time Frame
postoperative in-hospital stay up to 30 days
Title
30-day readmission rate after surgery
Description
Rate of readmission due to postoperative complications
Time Frame
postoperative in-hospital stay up to 30 days
Title
5-year disease-free survival (DFS)
Description
DFS at 5 year after surgery
Time Frame
5 year after surgery
Title
Tumor recurrence rate
Description
The rate of recurrence of thymoma in patients after surgery
Time Frame
5 year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ) The age of the subjects on the day of signing the informed consent was ≥ 18 years old and < 75 years old, regardless of gender ; ) Chest thin-layer CT and MR showed anterior mediastinal space-occupying lesions, combined with relevant hematological indicators, the patient was clinically diagnosed as a thymic epithelial tumor with or without myasthenia gravis ( MG ) symptoms. ) need to accept thymectomy surgery ; ) Clinical stage I to IIIA ( AJCC-UICC TNM staging system ) ; ) The maximum diameter of the lesion < 5cm ; ) physical condition score 0 or 1 ( Eastern Cooperative Oncology Group ECOG scoring system ) ; ) Have not received any anti-thymoma therapy before, including but not limited to systemic chemotherapy, radiotherapy, etc. ; ) Preoperative major organ function meets the following criteria : Bone marrow function: hemoglobin ≥ 10.0 g / dL ( no blood transfusion within 28 days before hemoglobin examination ), absolute neutrophil count ≥ 1.5 × 109 / L, platelet count ≥ 100 × 109 / L ( no transfusion of apheresis platelets or IL-11 treatment within 14 days before platelet count examination ) ; coagulation function : INR and PT < 1.5 × ULN, APTT ≤ 1.5 × ULN ; liver function: transaminase ( ALT and AST ) ≤ 2.5 × ULN; total bilirubin ≤ 1.5 × ULN ( Gilbert's syndrome or liver metastasis subjects total bilirubin ≤ 2.5 × ULN ) ; renal function: serum creatinine clearance rate ≥ 60 mL/min ( calculated according to the Cockcroft-Gault formula ) ; ) voluntarily participated in and were able to undergo robot-assisted or thoracoscopic thymectomy, and complied with the study follow-up plan. Exclusion Criteria: ) Patients with myasthenia gravis crisis ; ) had undergone mediastinal surgery or cardiac surgery ; ) body mass index ( BMI ) ≥ 30 ; ) Patients with severe liver and kidney dysfunction ( ALT and/or AST more than three times the upper limit of normal, Cr more than the upper limit of normal ) ; ) combined with severe chronic lung diseases such as COPD, asthma, or interstitial lung disease ; ) suffering from uncontrolled heart, kidney, gastrointestinal, and infectious diseases and other complications ; ) patients with other malignant tumors or hematological diseases ; ) combined with chronic pain or preoperative use of opioid analgesics ; ) patients with thoracic deformity or combined with pectus carinatum and pectus excavatum ; ) have mental disorders, such as anxiety disorders ; ) pregnant and/or lactating women ; ) is currently participating in other interventional clinical studies.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juemin Yu
Phone
+8615927548511
Email
yujm96@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Deping Zhao, MD,PhD
Phone
+8613701816883
Email
zdp1992@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deping Zhao, MD,PhD
Organizational Affiliation
Shanghai Pulmonary Hospital, School of Medicine, Tongji University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Zhejiang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junqiang Fan

12. IPD Sharing Statement

Plan to Share IPD
No

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Robot-assisted vs VATS for Thymoma

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