Surgery for Masaoka-Koga I-II Thymoma

NCT05001113 | Completed

• 1 other identifier: B2021-454
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to evaluate the safety and perioperative outcomes of the subxiphoid approach versus the lateral intercostal approach thoracoscopic thymectomy for Masaoka-Koga I-II thymoma.

Conditions

Thymoma; Masaoka Stage I; Masaoka Stage II

Keywords

thymoma (Masaoka Stage I-II); the subxiphoid approach; the lateral intercostal approach

Outcome Measures

Primary Outcomes (3)

• Dosage of analgesic medication after surgery

  The dosage of postoperative analgesic medication was the sum of the dosage of analgesics used for managing the pain of the patient after surgery. The analgesic medication includes analgesics in patient-controlled epidural analgesia (PCIA), injections, and oral medication.

  Up to the date of hospital discharge since the data of completion of surgery, up to 7 days

• Visual Analog Scales scores for postoperative pain

  The postoperative pain was evaluated for every enrolled patient by using the Visual Analog Scales (VAS). VAS: it typically asks a patient to place a mark on a line indicating the level of pain from 0 to 10. Zero indicates the absence of pain, while 10 represents the most intense pain possible.

  Up to the date of hospital discharge since the data of completion of surgery, up to 7 days

• Postoperative hospital stay

  Postoperative hospital stay is the duration for every enrolled patient until the date of meeting the criteria of hospital discharge since the date of surgery. The criteria of hospital discharge were defined as with the volume of postoperative drainage \< 200 ml/day, a normal chest X-ray, and good physical condition.

  Up to the date of meeting the criteria of hospital discharge since the data of surgery, up to 1 month

Secondary Outcomes (7)

• Operative time

  The duration until the finish of surgery since the start of the surgery, up to 5 hours

• Perioperative blood loss

  The duration until the finish of surgery since the start of the surgery, up to 5 hours

• Rate of conversion to open thoracotomy

  Up to the end of follow-up since the date of randomization, up to 6 months.

• Volume of postoperative drainage

  Up to the date of removal of drainage equipment since the data of completion of surgery, up to 7 days

• Postoperative treatment-related complications

  Up to the date of hospital discharge since the data of completion of surgery, up to 7 days.

Study Arms (2)

the subxiphoid approach thoracoscopic thymectomy

EXPERIMENTAL

The subxiphoid approach thoracoscopic thymectomy is performed in enrolled patients.

Procedure: the subxiphoid approach thoracoscopic thymectomy

the lateral intercostal approach thoracoscopic thymectomy

ACTIVE COMPARATOR

The lateral intercostal approach thoracoscopic thymectomy is performed in enrolled patients.

Procedure: the lateral intercostal approach thoracoscopic thymectomy

Interventions

the subxiphoid approach thoracoscopic thymectomy PROCEDURE

A 2-cm straight incision was made in the middle of the xiphoid process, the incision was used as a thoracoscope hole, and the xiphoid process could be removed if necessary. The surgeon used the oval forceps to release the left and right soft tissue gaps behind the sternum, from the anterior mediastinum tunnel. Two 0.5 cm extrapleural thoracic ports under the bilateral costal arches were created, and this incision was used as an operation hole. The thread puncture cone with a diameter of 0.5 cm was placed under the guidance of the finger.

Also known as: SATT

the subxiphoid approach thoracoscopic thymectomy

the lateral intercostal approach thoracoscopic thymectomy PROCEDURE

Right-side approach: Use the left supine position. The observing port was created at the right axillary midline line in the fourth intercostal space, and the other two ports were made as to the operation hole along the anterior axillary lines in the third and fifth intercostal spaces. Left-side approach: Use the right supine position. The observing port was created at the left axillary midline line in the fourth intercostal space, and the other two ports were made as to the operation hole along the anterior axillary lines in the third and fifth intercostal spaces.

Also known as: LATT

the lateral intercostal approach thoracoscopic thymectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Thymoma was diagnosed by chest enhanced CT (clinical stage: Masaoka Koga I-II);
• The patients whose tumor diameter was \<6 cm;
• The patients with age ≥ 18 and ≤ 75 years old, the estimated survival time should be over 12 months;
• ASA grade：1-2;
• The patients should have no functional disorders in main organs.;
• The patients should be able to understand our research and sign the informed consent.

You may not qualify if:

• Imaging examination showed that the tumor had invasion of surrounding organs, pleural or pericardial dissemination, lymphatic or hematogenous metastasis;
• Patients with myasthenia gravis;
• Patients had undergone a sternotomy;
• The patients have proved history of congestive heart failure, angina without good control with medicine; ECG-proved penetrating myocardial infarction; hypertension with bad control; valvulopathy with clinical significance; arrhythmia with high risk and out of control;
• The patients have severe systematic intercurrent disease, such as active infection or poorly controlled diabetes; coagulation disorders; hemorrhagic tendency or under treatment of thrombolysis or anticoagulant therapy;
• Female who is positive for serum pregnancy test or during lactation period;
• The patients have history of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation;
• The patients have history of peripheral nerve system disorders, obvious mental disorders or central nerve system disorders;
• The patients attend other clinical trials.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Zhongshan Hospital (Xiamen), Fudan University: collaborator
• Xuhui Central Hospital, Shanghai: collaborator
• Shanghai Minhang Central Hospital: collaborator
• Shanghai Qingpu Central Hospital: collaborator

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Thymoma

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Thymus Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Lijie Tan, MD

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: August 11, 2021
• Study Start: August 15, 2021
• Primary Completion: February 15, 2022
• Study Completion: August 17, 2022
• Last Updated: September 19, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)