Robot-assisted versus video-assisted thoracoscopic thymectomy for stage I–II thymic epithelial tumour: a protocol for the first multicentre, randomised controlled clinical trial

Abstract

Background

Minimally invasive approaches, including video-assisted thoracoscopic thymectomy (VATT) and robot-assisted thoracoscopic thymectomy (RATT), have emerged as alternatives to median sternotomy for resectable thymic epithelial tumours (TETs). However, their comparative clinical efficacy remains inconclusive due to limited prospective evidence. This phase II randomised controlled trial aims to provide the first direct comparative analysis of perioperative outcomes between RATT and VATT in stage I–II TETs.

Methods and analysis

This phase II clinical trial is a prospective, multicentre, randomised controlled study. A total of 100 patients with stage I–II TETs will be recruited and randomly allocated into two groups: RATT and VATT groups, with a 1:1 ratio. Follow-up visits will be scheduled at 1 month, 3 months and 6 months postsurgery, and semiannual visits will continue until November 2027, including the record of tumour recurrence, metastasis, survival outcomes and overall long-term effects. The primary endpoint is total postoperative thoracic drainage. Secondary outcomes encompass intraoperative factors like R0 resection rate, operative time, postoperative drainage duration, hospital stay length, conversion rates, levels of stress markers, pain scores, quality of life assessments, perioperative complication rates, mortality rates and 3-year disease-free and overall survival rates.

Ethics and dissemination

The study protocol is approved by the ethics committees of Zhongshan Hospital, Fudan University (No. B2024-365), and will be conducted under the guidance of the Helsinki Declaration. All data and findings will be disseminated and published through peer review.

Trial registration number

NCT06654830.

Correspondence to Professor Jianyong Ding; [email protected] ; Dr Yu Qi; [email protected] ; Dr Weiming Yue; [email protected]

STRENGTHS AND LIMITATIONS OF THIS STUDY

• This will be the first prospective, randomised controlled trial to evaluate perioperative outcomes between robot-assisted thoracoscopic thymectomy and video-assisted thoracoscopic thymectomy.

• The study is multicentre in design, involving high-volume institutions with standardised procedures and experienced surgeons.

• It adopts a pragmatic approach, featuring robust study settings, stringent patient selection criteria and clinically meaningful outcome measures.

• A potential limitation is the variability in surgeon experience across participating centres, which may introduce performance bias.

Introduction

Thymic epithelial tumours (TETs), comprising thymomas and thymic carcinomas, are the most prevalent malignancies of the anterior mediastinum, accounting for 20–40% of mediastinal tumours in adults.¹ The estimated global incidence is approximately 1.3–3.2 cases per million annually, with thymomas representing nearly 90% of cases.² While many patients are asymptomatic at presentation, 30–50% develop autoimmune disorders—most notably myasthenia gravis (MG), which affects over 20% of patients and substantially impairs quality of life.^{3 4} For stage I–II thymomas, complete surgical resection is the standard of care, as recommended by the International Association for the Study of Lung Cancer.⁵ According to the ninth edition of the tumour, node, metastases (TNM) classification, the 10-year overall survival rates for stage I and II TETs are 93% and 78%, respectively.⁶

Traditionally, median sternotomy has been the standard surgical approach for total thymectomy. While effective, it is associated with significant surgical trauma, disruption of thoracic stability and prolonged recovery.⁷ In contrast, video-assisted thoracoscopic thymectomy (VATT) has emerged as a preferred approach for early-stage disease, offering reduced surgical trauma, less postoperative pain and faster recovery. Long-term outcomes suggest that VATT achieves comparable 5-year overall survival and 10-year recurrence-free survival rates with open thymectomy, supporting its role as an effective minimally invasive alternative.⁸

More recently, the use of robot-assisted thoracoscopic thymectomy (RATT) has expanded with the introduction of the da Vinci surgical system. Early feasibility studies by Savitt et al and Rea et al established its safety and technical viability,^{9 10} and subsequent reports have demonstrated increasing adoption in clinical practice.^{11 12} Meta-analyses suggest that RATT may offer advantages in perioperative outcomes, including reduced blood loss, drainage volume and duration, while maintaining comparable 5-year recurrence-free survival rates.^{13 14} Moreover, RATT may improve postoperative quality of life, as reflected by higher scores on the 12-Item Short Form Health Survey.¹⁵ A recent study further demonstrated that RATT significantly reduced the duration of high-care nursing status compared with VATT, thereby contributing to better postoperative recovery.¹⁶ In addition, RATT has been associated with reduced postoperative pain and superior cosmetic outcomes, reinforcing its value in patient-centred surgical care.¹⁷ RATT may also offer clinical advantages in specific patient populations. For instance, in early-stage tumours (≤5 cm), robotic surgery has been associated with higher R0 resection rates, likely due to the improved visualisation of tumour margins.¹⁸ Furthermore, superior mediastinal fat clearance achieved through RATT may reduce postoperative myasthenic exacerbations.¹⁹

However, existing evidence is predominantly retrospective and subject to inherent limitations, including selection bias (eg, tumour size discrepancies), variability in perioperative care and lack of comprehensive outcomes reported.²⁰ Key comparisons between RATT and VATT—particularly in terms of cost-effectiveness, complication rates and oncological outcomes—remain inadequately addressed. Prospective studies with well-defined subgroups and comprehensive outcome measures are urgently needed to elucidate the role of RATT across diverse clinical scenarios. Ultimately, a multicentre randomised controlled trial (RCT) is essential to evaluate the potential superiority of RATT compared with VATT in patients with stage I–II TETs. Given its enhanced visualisation and greater surgical dexterity, we believe RATT may yield superior perioperative and long-term outcomes.

Objective

This prospective, multicentre, phase II randomised controlled trial aims to evaluate the perioperative efficacy of RATT compared with VATT in patients with stage I–II TETs, thereby generating high-quality evidence to inform precision surgical strategies in thymic malignancies.

Methods

Trial design

This is a prospective, multicentre, phase II randomised controlled trial designed to evaluate the perioperative efficacy of RATT versus VATT in patients with stage I–II TETs. A total of 100 eligible patients will be enrolled between November 2024 and November 2026 based on predefined inclusion and exclusion criteria. Participants will be randomised in a 1:1 ratio to undergo either RATT or VATT, with 50 patients allocated to each group. The trial will be conducted across three geographically diverse academic centres in China: Zhongshan Hospital, Fudan University (Southern China); Qilu Hospital, Shandong University (Northern China); and the First Affiliated Hospital of Zhengzhou University (Central Plains). Patient allocation will be managed through a central randomisation system with competitive enrolment across sites to ensure balance and efficiency. Both surgical approaches are well-established and will be performed according to standardised protocols by experienced thoracic surgeons. The primary objective is to determine whether RATT confers superior perioperative outcomes compared with VATT. Patient enrolment, surgery and perioperative data collection are expected to be completed by December 2026, with postoperative follow-up continuing through November 2027. A schematic overview of the study protocol is presented in figure 1.

Figure 1. Flow chart of the study procedure. TETs, thymic epithelial tumours; RATT, robot-assisted thoracoscopic thymectomy; VATT, video-assisted thoracoscopic thymectomy.

Surgery technique

All chief surgeons participating in this trial have independently performed more than 50 cases of both RATT and VATT and possess extensive expertise in both thoracoscopic and robotic surgical techniques. The da Vinci Surgical System will be used for all RATT procedures. Detailed surgical protocols have been published previously.²¹ The side of surgery will be determined based on tumour localisation. Patients will undergo general anaesthesia with double-lumen endotracheal intubation.

In the VATT group, a thoracoscope will be used for visualisation. After opening the bilateral mediastinal pleura, thymectomy will begin at the ipsilateral phrenic nerve and diaphragm and proceed cranially. The innominate vein will be exposed, and thymic veins will be ligated. Dissection will continue superior to the innominate vein and extend to the contralateral phrenic nerve, followed by careful mobilisation of both cervical horns. The entire thymus and surrounding adipose tissue will be resected en bloc and retrieved in a plastic sample bag. A chest drain will be inserted through the intercostal space to complete the procedure. No rib spreading will be involved.

In the RATT group, a robotic endoscope will be used for visualisation via the same trocar layout as in the VATT group. All ports will be connected to the da Vinci Surgical System. The mediastinal pleura will be dissected in a caudal-to-cranial direction. Thymic veins will be carefully clipped and divided without injuring the innominate vein. The thymus and surrounding fat tissue, including both cervical horns, will be resected en bloc and removed using a plastic sample bag through the central incision. A chest drain will be inserted transmediastinally, and incisions will be closed without rib spreading.

All procedures will be conducted with a unified protocol. In case of intercentre variability in surgical experience and technique, subgroup analyses will be conducted based on the origin centre.

Patient selection

Patients diagnosed with TET will be considered eligible for inclusion in this research. All investigators involved in the trial will be responsible for enrolling patients under the inclusion and exclusion criteria below to ensure consistency and reliability across all study sites.

Inclusion criteria

• Diagnosed with TET via chest-enhanced CT or MRI, classified as stage I–II based on the ninth edition of the TNM staging system (tables 1 and 2).

• Tumour diameter ≤8 cm on imaging.

• Age between 18 years and 75 years, with an expected lifespan of more than 12 months.

• An American Society of Anesthesiologists (ASA) classification of 1 or 2.

• No major organ dysfunction.

• Fully understanding the trial’s scope and providing written informed consent (See online supplemental file 1).

Table 1

Tumour, node and metastases components for the ninth edition of the TNM classification

T	Description	N and M	Description
T1	Tumour limited to the thymus with or without encapsulation or directly invades into the mediastinum alone or directly invades the mediastinal pleura but does not involve any other mediastinal structure.	N0	No nodal involvement
T1a	5 cm or less in its greatest dimension.	N1	Anterior (perithymic) nodes
T1b	larger than 5 cm in its greatest dimension.	N2	Deep intrathoracic or cervical nodes (eg, paratracheal, subcarinal, aortopulmonary window, hilar, jugular and supraclavicular nodes)
T2	Tumour directly invades the pericardium (either partial or full-thickness), the lung or the phrenic nerve.	M0	No metastatic pleural, pericardial or distant sites
T3	Tumour directly invades any of the following: (1) brachiocephalic vein, (2) superior vena cava, (3) chest wall or (4) extrapericardial pulmonary arteries or veins.	M1a	Separate pleural or pericardial nodule(s)
T4	Tumour directly invades any of the following: (1) aorta (ascending, arch, or descending); (2) arch vessels; (3) intrapericardial pulmonary artery or veins; (4) myocardium; (5) trachea; or (6) oesophagus.	M1b	Pulmonary intraparenchymal nodule or distant organ metastasis

M, metastasis; N, node; T, tumour.

Table 2

Stage definition for the ninth edition of the TNM classification

Stage	T	N	M
I	T1a-b	N0	M0
II	T2	N0	M0
IIIA	T3	N0	M0
IIIB	T4	N0	M0
IVA	T any	N1	M0
	T any	N0, N1	M1a
IVB	T any	N2	M0, M1a
	T any	N any	M1b

M, metastasis; N, node; T, tumour.

Exclusion criteria

• Imaging studies indicating surrounding organ invasion, pleural or pericardial dissemination or lymphatic/haematogenous metastases.

• Concurrent diagnosis of MG.

• History of surgery on the affected side of the chest (eg, prior sternotomy).

• Severe uncontrolled systemic diseases, including:hematological, renal, hepatic function, or/and pulmonary function unable to tolerate surgery.

• Uncontrolled cardiovascular conditions (eg, congestive heart failure, angina, myocardial infarction, hypertension, clinically significant valvulopathy or high-risk arrhythmias).

• Active infections or poorly controlled diabetes.

• Coagulation disorders, haemorrhagic tendency or ongoing thrombolytic/anticoagulant therapy.

• Pregnancy, lactation or positive serum pregnancy test.

• History of organ transplantation (including autologous bone marrow or peripheral stem cell transplantation).

• History of other malignancies or central/peripheral nervous system disorders.

• Participation in other clinical trials.

Withdrawal criteria

• Failure to adhere to the treatment methods outlined in the study protocol.

• Withdrawal of informed consent by the participant.

• Investigator’s judgement that the participant is no longer suitable to continue treatment for any reason.

Sample size consideration and randomisation

Based on prior retrospective studies and our institutional clinical experience, we anticipate a between-group difference in total thoracic drainage of 120 mL, with an estimated SD of 200 mL.^{13 14} To achieve 80% power with a two-sided α=0.05 and accounting for a 10% loss to follow-up, the required sample size is 100 patients, with equal allocation (1:1) to the RATT and VATT groups.

Participant randomisation will be conducted using a simple central randomisation with competitive enrolment across the three participating centres. The Biomedical Statistics Centre at Zhongshan Hospital, Fudan University, will manage the randomisation process. A computer-generated randomisation table will be used to assign participants in a 1:1 ratio to the RATT or VATT group. This study employs a single-blind design. Patients will be blinded to their treatment allocation, while surgeons and data analysts will remain unblinded due to the nature of the interventions. The operating surgeon will be informed of the treatment assignment 1 day prior to surgery, and the surgical team will be notified on the day of the procedure. The surgeon will conduct daily visits but will be excluded from clinical decision-making, including chest tube removal and patient discharge. These decisions will be made by blinded staff surgeons based on standardised criteria: normothermia, normal chest X-ray and clear fluid drainage of less than 200 mL/24 hours.²¹

Study endpoints

Primary endpoint

This study defines total postoperative thoracic drainage volume as the primary endpoint.

Secondary endpoints

• Complete resection rate, number of lymph node stations and lymph nodes sampled, operative time and intraoperative blood loss.

• Duration of drainage and postoperative hospital stay duration.

• Rate of re-operation.

• Stress marker levels (C reactive protein, procalcitonin, interleukin-6) on postoperative days 1 and 2 compared with preoperative levels.

• Visual analogue scale (VAS) on days 1, 2, 3 and 7.²²

• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) (V.3.0) scores at day 30, 60 and 180 postoperatively.²³

• Perioperative complication rates.

• 3-year disease-free survival (DFS) and overall survival rates.

Assessment and follow-up

Prior to enrolment, all patients must receive comprehensive information about the study and provide written informed consent. Perioperative management and data collection will be standardised across the three participating centres to ensure protocol consistency. Pretreatment assessments will be conducted within 1 week of hospital admission and will include clinical consultations, physical examinations, standard laboratory testing, inflammatory biomarkers (C reactive protein, procalcitonin and interleukin-6), cardiopulmonary function evaluations, tumour marker analyses, ASA physical status classification and contrast-enhanced chest CT scans. Eligibility will be determined based on predefined inclusion and exclusion criteria derived from the collected clinical data.

Postoperatively, all patients will receive standardised monitoring and care among three centres. After a 2-hour stay in the recovery unit, patients will be transferred to the general ward and encouraged to ambulate beginning on the first postoperative day. Standard laboratory evaluations will be performed until discharge. Pain management will include a patient-controlled intravenous analgesia (PCIA) pump without basal infusion, delivering sufentanil and ramosetron until chest tube removal. After PCIA withdrawal, further pain medication will only be provided if the pain is intolerable.

Patient-reported outcomes will be assessed at 30 days, 60 days and 180 days postoperatively. Pain intensity will be evaluated using the VAS, and data on chronic pain incidence and oral analgesic use will also be collected. Quality of life will be measured using two validated instruments: EORTC QLQ and the 36-Item Short Form Survey, the latter included to better reflect perioperative functional outcomes.²⁴ Principal investigators will administer both questionnaires via letter or telephone interviews. Subsequent follow-ups will include monitoring for tumour recurrence, metastasis, survival outcomes and overall health status. Patients will be required to complete semiannual follow-up assessments until study completion or death. All adverse events will be documented and managed according to established clinical protocols. Beyond study-specific follow-up, we will continue to provide routine postoperative care and remain responsible for long-term patient management.

End of the trial

The study will be considered complete once enrolment is finalised, perioperative clinical data are fully collected and all primary endpoints have been achieved. Patient enrolment is projected to be completed by November 2026, with the study concluding by November 2027. The trial should be terminated under the following conditions:

• Enrolment of participants is less than 50% after 1 year.

• Significant differences in perioperative complications and survival outcomes are observed between the two groups.

• Severe adverse events occur among participants.

• Loss to follow-up exceeds 20%.

Statistical analysis

All collected data—including demographic characteristics, clinical assessments, surgical details and postoperative outcomes—will be systematically recorded using standardised case report forms. Statistical analyses will be conducted using SPSS software (V.26.0, IBM Corp). Continuous variables will be summarised as mean±SD or as medians with corresponding minimum and maximum values, depending on data distribution. Categorical variables will be reported as frequencies and percentages. Data will be primarily presented in tabular format, with group comparisons organised along the vertical axis. Where appropriate, statistical graphs will be used to enhance interpretability. All hypothesis testing will be two-sided, with a significance threshold set at p value <0.05. For continuous variables (eg, thoracic drainage volume, duration of drainage and inflammatory marker levels), comparisons between groups will be performed using the Student’s t-test. For categorical variables (eg, sex and complete resection rate), the χ² test or Fisher’s exact test will be applied as appropriate. Subgroup analyses will be conducted based on key stratification variables, including tumour size, sex and study centre, to assess the consistency of treatment effects across different clinical contexts.

Discussion

Minimally invasive surgery—including RATT and VATT—has gained increasing popularity due to its advantages over traditional open surgery, such as reduced postoperative pain, improved cosmetic outcomes and faster recovery. In lung and oesophageal cancer, prospective comparisons between video-assisted and robot-assisted thoracic surgery have demonstrated encouraging results, including improved DFS, shorter hospital stays, decreased postoperative pain and fewer complications.^25–27 However, to date, no authoritative prospective RCT has directly compared the perioperative efficacy of RATT versus VATT in patients with thymic tumours. The present study seeks to address this gap by providing high-level evidence to inform clinical decision-making in the management of resectable TETs.

Our previous research has established VATT as a safe and effective surgical approach for patients with stage I–II TETs. VATT facilitates complete resection of the tumour, thymus and surrounding mediastinal fat while providing adequate exposure of critical structures such as the upper thymus, innominate vein and lateral wall of the vena cava. It also enables the thoracoscopic removal of tumour-invaded adjacent tissues, including the lung, pericardium, phrenic nerve and innominate vein. VATT has demonstrated favourable perioperative outcomes, including minimal surgical trauma, reduced postoperative pain and improved cosmetic results.²⁸ A retrospective analysis of 221 patients with stage T2–3 TETs who underwent surgery at Zhongshan Hospital, Fudan University (2015–2020), showed that VATT significantly outperformed traditional open surgery in terms of operative time, blood loss, chest tube duration, hospital stay and postoperative complication rates, with comparable 5-year DFS and overall survival.²⁹ Accordingly, VATT is currently recommended as the standard surgical approach for stage I–II TETs by the National Comprehensive Cancer Network guidelines.

While RATT offers comparable perioperative safety to VATT,^{15 29} accumulating retrospective evidence highlights its potential technical advantages, including shorter hospital and intensive care unit stays, reduced operative time and decreased postoperative drainage—all summarised in table 3.^{11 16 17 19 30–32} Enhanced features of the robotic platform, such as high-definition, real-time three-dimensional visualisation and tremor filtration, may further improve surgical precision.³³ At our institution, 60 consecutive RATT procedures resulted in 100% R0 resection rates without grade III–IV complications or conversions, underscoring the safety and reproducibility of the robotic approach. These findings align with multi-institutional data demonstrating superior instrument articulation for vascular dissection and mediastinal fat clearance—both critical for reducing recurrence risk.³³

Table 3

Outperforming outcomes of RATT compared with VATT

Author	Year	Patient	Outcomes (VATT vs RATT)	P value
Imielski et al30	2020	n=151	Shorter hospital duration of stay: 2.4±3.2 vs 1.3±0.8 days	0.010
Li et al31	2020	n=295	Shorter surgical time: 107.83±15.616 vs 102.10±14.125 min	0.010
Şehitogullari et al19	2020	n=45	Shorter surgical time: 106.52±26.68 vs 75.70±38.08 min	<0.001
			Less operative drainage: 325.45±25.38 vs 210.34±20.22 mL	<0.001
			Shorter duration of postoperative drainage: 5.10±3.21 vs 3.10±2.20 days	<0.001
			Shorter hospital duration of stay: 5.76±1.27 vs 4.16±1.15 days	<0.001
Chiba et al16	2022	n=57	Shorter B duration (based on nursing criteria): 3 (1 to 7) vs 2 (1 to 4)	< 0.001
			Shorter CIII duration (based on nursing criteria): 5 (1 to 14) vs 3 (1 to 6)	0.037
Chao et al11	2024	n=312	Shorter postoperative ICU duration: 6.16±9.29 vs 1.14±0.36 days	0.027
			Shorter duration of postoperative drainage: 2.61±2.29 vs 1.96±0.97 days	0.047
			Shorter hospital duration of stay: 3.91±5.11 vs 3.03±1.78 days	0.041
Patel et al32	2024	n=732	More R0 resection: 94.7% vs 98.3%	<0.001
Trabalza Marinucci et al17	2025	n=80	Shorter surgical time: 90.00±11.55 vs 70.60±8.13 min	0.030
			Less conversion rate: 15% vs 0%	0.026
			Less pain score in 24 hours: 4.3±0.5 vs 2.2±0.8	0.004
			Less pain score in 48 hours: 4.0±0.9 vs 2.2±0.7	0.014

ICU, intensive care unit; RATT, robot-assisted thoracoscopic thymectomy; VATT, video-assisted thoracoscopic thymectomy.

Based on prior evidence and institutional experience, we hypothesise that RATT is superior to VATT in terms of perioperative efficacy for patients with stage I–II TETs, particularly regarding reduced postoperative thoracic drainage. This prospective clinical trial aims to provide robust comparative data on these two minimally invasive approaches, thereby informing optimal surgical strategies for resectable thymic tumours.

Limitations

Despite standardised protocols across centres, variability in surgical experience and technique may introduce interinstitutional heterogeneity, potentially confounding outcome comparisons. Moreover, the exclusion of a median sternotomy (open surgery) control group limits direct benchmarking against conventional surgical standards. The inclusion criteria—which allow for tumour sizes up to 8 cm and a broad age range (18–75 years)—may also restrict the generalisability of subgroup findings. Future investigations should emphasise procedural harmonisation through intraoperative video review and extend follow-up duration to evaluate long-term oncological and functional outcomes of robotic surgery platforms.

Ethics and dissemination

The study protocol is approved by the ethics committees of Zhongshan Hospital, Fudan University (No. B2024-365) and will be conducted under the guidance of the Helsinki Declaration. All data and findings will be disseminated and published through peer review journals.

Ethics statements

Patient consent for publication

Not applicable.

Footnote

SW, JZ, ZS, JJ and BW contributed equally.

Contributors JD, WY and YQ conceived the study, and JD served as its guarantor. SW, ZS and BW collected samples and clinical data. SW and JZ drafted the manuscript. JJ, XJ, YA, JG and LT revised the manuscript and study methods. FL was responsible for the statistics. All authors read and finally approved the manuscript.

Funding This work was supported by the National Key Research and Development Program of China (2023YFC3402700) and the National Natural Science Foundation of China (82404059, 82473289, 82472924, 81802397).

Competing interests None declared.

Patient and public involvement Patients and/or the public were involved in the design, conduct, reporting or dissemination plans of this research. Refer to the Methods section for further details.

Provenance and peer review Not commissioned; externally peer reviewed.

Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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