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The aim of this study is to perform a prospective, single-center, randomized controlled study to explore whether closed insufflation technique is not inferior to dilatation and collapse technique in segmentectomy, and to provide a new option for establishing intersegmental plane in segmentectomy.
This is a single-center, prospective, randomized controlled study. A total of 200 subjects undergoing segmentectomy are scheduled to be enrolled within 1 year, and the subjects are randomly divided into closed insufflation group or dilatation and collapse group using a random number table generated by the computer, with 100 cases in each group. Intersegmental plane resolution grading, perioperative complications, operative time, intraoperative blood loss, postoperative hospitay stay, and pulmonary function 3 months and 1 year after surgery will be extracted and compared between the groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Closed insufflation technique group | Experimental | Closed insufflation technique is characterized by ligation in the proximal portion of targeted bronchus and gas injection in the distal portion. Closed insufflation technique group includes patients undergoing segmentectomy using closed insufflation technique. |
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| Dilatation and collapse technique | Active Comparator | Dilatation and collapse technique is characterized by pure oxygen dilatation and subsequent collapse after the division of targeted bronchus. Dilatation and collapse technique group includes patients undergoing segmentectomy using Dilatation and collapse technique. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implementation of closed insufflation technique during segmentectomy | Procedure | After the identification the targeted segmental bronchus during the operation,ligating the proximal end of the targeted bronchus. Put the vessel separation forceps in the distal bronchial space to avoid the accidental damage of the vessels. Use a 50ml syringe to inject air into the distal bronchus (about 100ml is expected) until the intersegmental plane is satisfactory. Divide the target bronchus using the cutting and closing device. |
| Measure | Description | Time Frame |
|---|---|---|
| Intersegmental plane clarity grading | Intersegmental plane clarity will be graded as followed: G1: partial collapse of targeted parenchymal tissue, G2: partial dilatation of non-targeted adjacent tissue, G3: dilatation of targeted tissue and unclearness of intersegmental plane, G4: entire dilatation of targeted tissue and clearness of intersegmental plane. | intraoperatively |
| Surgical complications | Surgical complications will be assessed according to the Society of Thoracic Surgeons database criteria. | Up to 3 months |
| Operative time required for segmentectomy | Operative time required for segmentectomy will be measured as the total minutes from initiation to completion of segmentectomy. | From the dissection of segmental structures to finish of segementectomy |
| Pulmonary function 3 months and 1 year after surgery | Pulmonary function includes ventilation and diffusion function. Pulmonary function will be measured at two time points including 3 months and 1 year after surgery. | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative blood loss | Intraoperative blood loss will be measured as the total volume of blood loss during the operation. | Intraoperatively |
| Postoperative hospital stay | Postoperative hospital stay will be measured as the number of days between surgery and discharge. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Hu, M.D., Ph.D. | Contact | +8685296122 | yanhu@csu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Thoracic Surgery, Second Xiangya Hospital of Central South University, China | Changsha | Hunan | 410011 | China |
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| ID | Term |
|---|---|
| D004108 | Dilatation, Pathologic |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Implementation of dilatation and collapse technique during segmentectomy | Procedure | Divide the target bronchus using the cutting and closing device. Ask the anesthesiologist to inflate the lung completely from pure oxygen to the affected side and then change to single lung ventilation. Wait for the intersegmental plane to appear(usually about 15 minutes). |
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| Up to 2 weeks |
| Days of chest tube placement | Days of chest tube placement will be measured as the number of days between surgery and chest tube pull-out. | Up to 2 weeks |
| Safety margin | Minimum distance between nodule and every margin can be measured preoperatively by 3D reconstruction tool and intraoperatively by ruler after the targetd segment has been resected. | Up to 1 week |
| Volume of targeted parenchymal tissue | Volume of targeted parenchymal tissue will be calculated by 3D reconstruction tool. | Up to 3 days |