Comparison of Energy Instruments and Stapling Device to Dissect Intersegmental Plane in Segmentectomy

NCT03192904 | Terminated Results

• 1 other identifier: RTS-004
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

According to published studies, there are two main approaches in the dissection of intersegmental plane: stapling devices and energy instrument separation. However, only a few retrospective studies focused on the perioperative outcomes of these two approaches, and there has been no definitive conclusion about which method is better. So the investigators want to conduct a prospective study, trying to figure out this problem.

Conditions

Segmentectomy

Keywords

Lung cancer; Segmentectomy; Postoperative Complication; Stapling Device; Energy Device

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Complications

  The primary outcome was the incidence of postoperative complications, including air leakage (defined as a rate of air flow \>50 mL/min lasting more than 3 days), atelectasis (visible on chest X-rays with complaints), hemorrhage (bloody drainage more than 200 mL for 3 consecutive hours), pulmonary infection (visible on chest X-rays with complaint), and pulmonary embolism (confirmed by CT scan).

  postoperative in-hospital stay up to 30 days

Secondary Outcomes (14)

• Incidence Rates of Each Postoperative Complications

  postoperative in-hospital stay up to 30 days

• Preoperative Lung Function

  Baseline.

• Postoperative Lung Function at the 3rd Month After Surgery

  at the 3rd month after surgery

• Postoperative Hospital Stay

  up to 24 weeks

• Postoperative ICU Stay

  up to 24 weeks

Study Arms (2)

Energy Instruments Group

EXPERIMENTAL

All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use energy instruments dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.

Device: Energy Instruments

Stapling Device Group

EXPERIMENTAL

All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use stapling device to dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.

Device: Stapling Device

Interventions

Energy Instruments DEVICE

Energy Instruments, including electrocautery, harmonic scalpel and LigaSure.

Energy Instruments Group

Stapling Device DEVICE

Stapling Device, including linear stapler and curved stapler.

Stapling Device Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age: 18 to 70 years old; 2. Pulmonary nodules or GGO found in chest CT examination, and conform with indications for segmentectomy mentioned in NCCN guidelines:
• Poor pulmonary reserve or other major comorbidity that contraindicates lobectomy;
• Peripheral nodule ≤2 cm with at least one of the following:
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• Pure (Adenocarcinoma in situ) AIS histology;
• Nodule has ≥50% ground-glass appearance on CT;
• Radiologic surveillance confirms a long doubling time (≥400 days). 3. Normal in preoperative tests, such as blood routine examination, liver function, renal function, coagulation function, etc.
• \. ASA score: Grade I-III. 5. Patients who can coordinate the treatment and research and sign the informed consent.

You may not qualify if:

• \. Patients have history of malignant tumor, or have accepted neoadjuvant chemotherapy and(or) radiotherapy.
• \. Patients have comorbidities in cardiovascular, kidney, lung or hematopoietic system, who cannot tolerate the surgery.
• \. Psychiatric patients。 4. Patient have history of chest trauma or surgery on ipsilateral chest.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Lung Neoplasms; Postoperative Complications

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

First, we only used electrocautery to divide intersegmental planes in the energy instrument group. Second, the single-center design might lead to selection bias. Third, oncological outcomes were not available.

Results Point of Contact

• Title: Prof. Hecheng Li, Chair of Thoracic Surgery
• Organization: Ruijin Hospital Shanghai JiaoTong University School of Medicine

lihecheng2000@hotmail.com

(86)13917113402

Study Officials

• Hecheng Li, MD, PhD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Xingshi Chen, MD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 20, 2017
• Study Start: June 1, 2017
• Primary Completion: March 9, 2018
• Study Completion: June 9, 2018
• Last Updated: August 31, 2021
• Results First Posted: July 13, 2020

Record last verified: 2021-08

Locations

CN (1)