Phase III Study of Additional Minocycline Pleurodesis After Video-Assisted Thoracoscopic Surgery for Primary Spontaneous Pneumothorax

Patients and Methods Study design This study is a randomized trial of additional minocycline pleurodesis after VATS for primary spontaneous pneumothorax. It was begun in June 2001 in Thoracic Surgical Division, National Taiwan University Hospital. After VATS for primary spontaneous pneumothorax, eligible patients were randomly assigned to additional minocycline pleurodesis or observation. The primary end point was rate of ipsilateral recurrence after the operation. Secondary end points included safety, early postoperative results, and long-term effects of minocycline pleurodesis. Consents were obtained from patients after thorough explanation. The protocol was approved by the Institutional Review Board of National Taiwan University Hospital.

Eligibility criteria All patients requiring VATS caused by ipsilateral recurrence, continuous air leaks for > 3 days, contralateral recurrence, presence of hemopneumothorax, or uncomplicated first episode with professions at risk were eligible for this study. The exclusion criteria were: greater than 50 years of age, underlying pulmonary disease, previous ipsilateral thoracic operation, allergy to tetracycline or minocycline, and unwillingness to randomization.

Operative technique of VATS After confirmation of patient eligibility, either conventional or needlescopic VATS was performed for these patients by his or her own choice. The cost of the operation and cosmetic results were the main points considered by the patients as they made their choices. The cost of needlescopic VATS is higher than that of conventional VATS because our National Health Insurance will cover only a part of the disposable equipment. Our previous study showed that the short-term results and recurrence rates of both techniques were comparable, although needlescopic VATS provides better cosmetic results and less residual chest pain.19 Conventional VATS was performed in a standard fashion under general anesthesia using intubation with a double-lumen endotracheal tube. The patients were placed in a lateral decubitus position, and the ipsilateral lung was deflated. A 10-mm, 30-degree telescope (Karl Storz, Tuttlingen, Germany) was first inserted to examine the pleural cavity. Two 15-mm skin incisions were made at the third or fourth intercostal space, anterior and posterior axillary line. Light pleural adhesions were freed using electrocautery. When blebs were identified, they were grasped with the ring forceps and excised with a 45-mm endoscopic stapler. Blind apical stapling was done at the most suspicious area if no bleb could be identified. The entire parietal surface was abraded by inserting the dissector with a strip of diathermy scratch pad through the port sites. After postoperative lung reinflation, normal saline solution was instilled to check for air leaks. A chest tube (28F) was placed in the apex through one of the insertion wounds. The surgical specimens were routinely sent for pathological examination.

The anesthesia, preparation, and operative procedures of the needlescopic VATS were almost identical to the conventional VATS. However, two sets of independent video-thoracoscopic equipment and monitors, one for needlescopic videothoracoscopy and the other for 10-mm videothoracoscopy, were used simultaneously and placed near the patient's head. Basically, we used the 10-mm videothoracoscopy for most of the surgical steps. A needlescope was indicated only when we need the chest tube wound to insert the endoscopic stapler and ring forceps, to extract the specimen, or to perform pleural abrasion.19

Postoperative care and minocycline pleurodesis The patients were extubated in the operating theater and observed for 1 to 2 hours in the recovery room. Postoperative analgesics include routine oral, non-steroid analgesics and acetaminophen. Intensity of postoperative pain was evaluated by a visual analogue scale (VAS; zero represented no pain and 10 represented intractable pain) on the first, second, and third postoperative days. Intramuscular meperidine hydrochloride (Demerol®, 50mg/ampule) was administered every 4 to 6 hours according to the patient's request if the pain became intolerable, could not be relieved by oral analgesics, and visual analogue scale was greater than 7. Chest radiography was performed immediate postoperatively or the next morning. The chest tube was connected to a low-pressure suction system of around -10 to -20 cmH2O if the lung was not fully expanded.