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A prospective, randomized controlled clinical trial for comparison of the postoperative pulmonary function between segmentation with energy instruments and mechanical segmentation with cutting stapler in lung segmentectomy

A prospective, randomized controlled clinical trial for comparison of the postoperative pulmonary function between segmentation with energy instruments and mechanical segmentation with cutting stapler in lung segmentectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024282
Enrollment
Unknown
Registered
2019-07-04
Start date
2019-08-01
Completion date
Unknown
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Interventions

Extensively dissection with energy instruments (Experiment group):The electrosurgical or ultrasonic scalpel was used to separate the intersegmental plane
Mechanical segmentation with cutting stapler (Control group):The cutting stapler will be used to separate the intersegmental plane

Sponsors

Shanghai Pulmonary Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Aged >= 18 years and 70%); (5) Performance status of ECOG 0 or 1; (6) Preoperative ASA scoring (American society of anesthesiology) class I to III; (7) Patients can cooperate with treatment and research, and can also fully understand the contents of informed consent and signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Preoperative CT scan or pathological biopsy indicated the presence of mediastinal lymph node metastasis; (2) Evidence indicated that there is distant metastasis or pleural metastasis found during operation; (3) Patients with other malignant tumors; (4) Patients who have undergone neoadjuvant chemoradiotherapy, or received radiotherapy and (or) chemotherapy because of the history of malignant tumors; (5) Patients with a history of chest trauma or chest surgery; (6) Female during pregnancy or lactation; (7) Patients with severe damage to heart, liver and kidney function (grade 3~4, ALT and/or AST over 3 times the normal upper limit, Cr over the normal upper limit).

Design outcomes

Primary

MeasureTime frame
FEV1 at the 12th months postoperatively;

Secondary

MeasureTime frame
Postoperative length of stay;The indwelling time of postoperative closed thoracic drainage tube;Lung function indicators at the 1st, 3rd, 6th and 12th months postoperatively: FEV1, FVC, and DLCO;Lung morphology evaluation at the 1st, 3rd, 6th and 12th months postoperatively (CT reconstruction and imageological assessment);Postoperative life quality scale scores (SF-36 and SGRQ) at the 1st, 3rd, 6th, 12th and 24th months post-operatively after surgery;The incidence rate of postoperative complications;

Countries

China

Contacts

Public ContactChang Chen

Shanghai Pulmonary Hospital

chenthoracic@163.com+86 13816839003

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026