Robot-assisted vs VATS Lobectomy for NSCLC

NCT ID: NCT03134534

Last Updated: 2023-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2023-05-31

Brief Summary

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Robot-assisted thoracoscopic surgery (RATS) was widely used in thoracic surgery, the surgical safety and feasibility of RATS lobectomy for NSCLC has been confirmed. However, the oncological long-term outcomes of RATS lobectomy has not been studied by randomized controlled trial, the purpose of this study is to determine whether RATS lobectomy would be as effective as VATS lobectomy on short-term and long-term outcomes.

Detailed Description

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Video-assisted thoracoscopic surgery (VATS) lobectomy is recommended for non small cell lung cancer (NSCLC) with surgical indications in China, its oncological long-term outcomes has been widely approved. As a new form of VATS, robot-assisted thoracoscopic surgery (RATS) was widely used in thoracic surgery, the 3D vision and flexible robot arm were helpful for surgeons to perform precise operations, and RATS was reported to bring extra benefits to patients. The surgical safety and feasibility of RATS lobectomy for NSCLC has been confirmed. However, the oncological long-term outcomes of RATS lobectomy has not been studied by randomized controlled trial. so we designed this randomized controlled trial to determine whether RATS lobectomy would be as effective as VATS lobectomy on short-term and long-term outcomes.

Conditions

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Pulmonary Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VATS group

Surgical procedure: VATS lobectomy

Group Type OTHER

VATS lobectomy

Intervention Type PROCEDURE

a minimal invasive surgical types for NSCLC: VATS lobectomy

RATS group

Surgical procedure: RATS lobectomy

Group Type OTHER

RATS lobectomy

Intervention Type PROCEDURE

a minimal invasive surgical types for NSCLC: RATS lobectomy

Interventions

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VATS lobectomy

a minimal invasive surgical types for NSCLC: VATS lobectomy

Intervention Type PROCEDURE

RATS lobectomy

a minimal invasive surgical types for NSCLC: RATS lobectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. surgical indication for lobectomy;
2. minimal invasive surgery;
3. ASA (American Society of Anesthesiologists) stage: I-III;
4. sign the informed consent. -

Exclusion Criteria

1. benign tumor or nodule;
2. present of other malignancy;
3. preoperative chemotherapy, radiotherapy, targeted therapy. -
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hecheng Li M.D., Ph.D

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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He-Cheng Li, doctor

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

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Ruijin Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Li C, Chen X, Wang X, Guo W, Zhang Y, Chen F, Li H. Single-Port Robotic-Assisted Approach in Thoracic Surgery: A Prospective Real-World Study. Interdiscip Cardiovasc Thorac Surg. 2025 Jul 3;40(7):ivaf161. doi: 10.1093/icvts/ivaf161.

Reference Type DERIVED
PMID: 40658465 (View on PubMed)

Niu Z, Cao Y, Du M, Sun S, Yan Y, Zheng Y, Han Y, Zhang X, Zhang Z, Yuan Y, Li J, Zhang Y, Li C, Han D, Du H, Guo W, Chen K, Xiang J, Zhu L, Che J, Hang J, Ren J, Lerut T, Abbas AE, Lin J, Jin R, Li H. Robotic-assisted versus video-assisted lobectomy for resectable non-small-cell lung cancer: the RVlob randomized controlled trial. EClinicalMedicine. 2024 Jul 12;74:102707. doi: 10.1016/j.eclinm.2024.102707. eCollection 2024 Aug.

Reference Type DERIVED
PMID: 39105193 (View on PubMed)

Jin R, Zhang Z, Zheng Y, Niu Z, Sun S, Cao Y, Zhang Y, Abbas AE, Lerut T, Lin J, Li H. Health-Related Quality of Life Following Robotic-Assisted or Video-Assisted Lobectomy in Patients With Non-Small Cell Lung Cancer: Results From the RVlob Randomized Clinical Trial. Chest. 2023 Jun;163(6):1576-1588. doi: 10.1016/j.chest.2022.12.037. Epub 2023 Jan 5.

Reference Type DERIVED
PMID: 36621757 (View on PubMed)

Jin R, Zheng Y, Yuan Y, Han D, Cao Y, Zhang Y, Li C, Xiang J, Zhang Z, Niu Z, Lerut T, Lin J, Abbas AE, Pardolesi A, Suda T, Amore D, Schraag S, Aigner C, Li J, Che J, Hang J, Ren J, Zhu L, Li H. Robotic-assisted Versus Video-assisted Thoracoscopic Lobectomy: Short-term Results of a Randomized Clinical Trial (RVlob Trial). Ann Surg. 2022 Feb 1;275(2):295-302. doi: 10.1097/SLA.0000000000004922.

Reference Type DERIVED
PMID: 33938492 (View on PubMed)

Other Identifiers

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RTS-002

Identifier Type: -

Identifier Source: org_study_id

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