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https://doi.org/10.1007/s11748-019-01207-2
ORIGINAL ARTICLE
Abstract
Objective Pulmonary fistula is a common complication in pulmonary lobectomy for non-small cell lung cancer (NSCLC).
Although a linear staple device with bioabsorbable polyglycolic acid (PGA) is used for pulmonary wedge resection with
fragile pulmonary parenchyma, the efficacy of the stapler with PGA for dividing incomplete interlobular fissure in pulmo-
nary lobectomy has not been elucidated. This study aimed to evaluate the usefulness of the stapler with PGA in reducing
postoperative air leakage when dividing incomplete interlobular fissure in pulmonary lobectomy for NSCLC.
Methods A total of 546 patients who underwent radical lobectomy for NSCLC were analyzed retrospectively. Propensity
score analysis generated two matched pairs of 125 patients in both stapler and stapler with PGA groups.
Results After propensity score matching, postoperative air leakage following pulmonary lobectomy was significantly less
frequent in the stapler with PGA group (9.6%) than in the stapler group (22.4%, p = 0.006). Intraoperative additional man-
agement of PGA and/or fibrin glue was decreased in the stapler with PGA group (56.0% vs. 70.4%, p = 0.018, 54.4% vs.
69.6%, p = 0.013, respectively). On logistic regression analysis, stapler with PGA was an independent factor for preventing
postoperative air leakage (odds ratio, 0.38; p = 0.015).
Conclusions Using the stapler with PGA to divide the incomplete interlobular fissure in pulmonary lobectomy reduced
postoperative air leakage, and decreased the need for additional intraoperative management using fibrin glue.
Keywords Lung cancer · Pulmonary lobectomy · Air leakage · Linear stapler · Bioabsorbable polyglycolic acid
* Hajime Saito
hasaito@iwate‑med.ac.jp
1
Department of Thoracic Surgery, School of Medicine,
Iwate Medical University, 2‑1‑1 Idai‑dori, Yahaba, Shiwa,
Iwate 028‑3695, Japan
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Patients and methods thoracotomy dividing part of the latissimus dorsi and ante-
rior serratus muscles. Complete VATS lobectomy was per-
Patient selection formed via a three-port method with monitor vision only.
To divide the incomplete interlobular fissure in pulmo-
We reviewed medical records for this retrospective cohort nary lobectomy, automatic linear stapler devices were used.
study. All patients had NSCLC and underwent radical Up to January 2015, simple staplers (without PGA) were
lobectomy between January 2014 and October 2018 at used for dividing the incomplete interlobular fissure (stapler
Iwate Medical University Department of Thoracic Surgery. group, n = 135) in our institute, and staplers with PGA were
This study was approved by the institutional review board used from February 2015 (stapler with PGA group, n = 328).
at Iwate Medical University, and the need for informed In particular, Endo GIA Reinforced Reload with Tri-Staple
consent was waived based on the retrospective design (per- technology® (purple, 60 mm; Medtronic, Minneapolis, MN)
mit number: H28-194). were used as staplers with PGA, and Endo GIA Reload with
Surgical indications for complete video-assisted thora- Tri-Staple Technology® (purple, 60 mm; Medtronic) were
coscopic surgery (c-VATS) lobectomy comprise the mainly used as a simple stapler.
concept of a thoracoscopically resectable lesion, cover- Systematic complete hilar and mediastinal lymph node
ing almost 95% of surgical patients with NSCLC in our dissection was performed in all cases. After completing
institute. Cases of completed interlobular fissure in which the procedure, a sealing test was performed before wound
an automatic linear stapler was not required, pneumonec- closure. The sealing test was confirmed with reinflation of
tomy, bilobectomy, and sublobar resection were excluded. the lung on the affected side, additional management with
All patients underwent complete preoperative pulmonary PGA sheet ( NEOVEIL® sheet; GUNZE, Osaka, Japan) and/
evaluation. Pulmonary function was tested at our insti- or fibrin glue ( Beriplast® P combi-set tissue adhesion; CSL
tute using a spirometer (CHESTAC 8800; CHEST M.I., Behring, Tokyo, Japan, or B OLHEAL®, TEIJIN Pharma,
Tokyo, Japan) according to the standards of the Ameri- Tokyo, Japan) was performed in the case of air leakage.
can Thoracic Society [7]. Vital capacity (VC) and forced Finally, a chest tube ( Blake®, 19-Fr; Ethicon, Somerville,
expiratory volume in 1 s ( FEV1) were measured in patients NJ) was placed from the fifth intercostal trocar to the apex.
preoperatively within 1 month before surgery. Patients
with chronic obstructed pulmonary disease (COPD) were Postoperative management
treated by bronchodilator therapy for at least 4 weeks pre-
operatively, and smoking was stopped for at least 8 weeks Chest X-rays were obtained daily. The chest tube was suc-
before surgery. Postoperative complications within 30 days tioned at -5 cmH2O on the morning of postoperative day 1.
after surgery were defined as Clavien–Dindo classifica- Chest tube withdrawal criteria were: absence of air leak-
tion grade II or higher [8]. Postoperative pulmonary com- age through the chest tube at the time of evaluation; pleural
plications [9] included pneumonia, prolonged air leak, fluid drainage < 200 mL/24 h; and postoperative chest X-ray
interstitial pneumonitis (IP), atelectasis, bronchopleural showing no pneumothorax. On the morning after chest tube
fistula, bronchial asthma, hypoxemia and acute respiratory withdrawal, chest X-ray was performed to exclude the pres-
distress syndrome. Cases showing multiple complications ence of pneumothorax. Routine postoperative pain manage-
were categorized according to the complication that most ment was performed in all patients of both groups. Briefly,
affected the postoperative outcome. Prolonged air leak was oral analgesia was started a day after surgery and typically
defined as air leakage lasting ≥ 7 days [10]. A final total of included loxoprofen at 60 mg, three times per day, some-
463 patients met the selection criteria. times with 25-mg diclofenac suppositories one or two times
per day, as needed. Patients were discharged when conveni-
ent, if no complications occurred during this perioperative
Surgical procedures period. Our institutional standard protocol is to follow-up
almost patients every 3–6 months after surgery for 5 years.
Pulmonary lobectomy was performed under general anes-
thesia with a double-lumen endotracheal tube for single-
lung ventilation. The affected lung was deflated as soon Cost analysis
as the pleural space was opened, and deflation was main-
tained throughout most of the operative period. The frac- The cost of the stapler cartridge was 36,000 JPY and the
tion of inspired oxygen (FiO2) during surgery ranged from stapler with PGA cartridge was 58,200 JPY for each device.
0.3 to 1.0 based on intraoperative blood gas analysis evalu- The cost of each additional PGA sheet was 9,650 JPY, fibrin
ation. The open method was performed via posterolateral glue cost 36,625 JPY for 3 ml and 59,259 JPY for 5 ml. This
study calculated costs based on these prices.
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The results of multivariate analysis of the independent Table 4 shows the mean cost comparison between stapler
risk predictors for postoperative air leakage are shown in and stapler with PGA groups. The mean cost of additional
Table 3. Using the stapler with PGA was an independent fac- PGA and fibrin glue was lower in the stapler with PGA
tor related to reducing postoperative air leakage in matched
patients (OR, 0.38; p = 0.015).
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Table 3 Logistic regression analysis of independent risk predictors postoperative air leakage even if no problem is evident mac-
for postoperative air leakage on pulmonary lobectomy roscopically during surgery. In other words, the macroscopic
Variable After propensity score matching findings may not necessarily agree with the actual vulner-
ability. Prediction of postoperative air leakage before surgery
OR 95% CI p value
has proven extremely difficult so far, and preoperative factors
Age (≧ 70 years) 1.47 0.67–3.32 0.338 such as COPD, history of DM or steroid therapy did not cor-
Gender (male) 2.61 0.90–7.95 0.077 relate with postoperative air leakage in this study.
BMI (≧ 25 kg/m2) 0.64 0.24–1.55 0.326 The principle of preventing pulmonary fistula, of course,
Brinkman index (≧ 400) 1.49 0.54–4.17 0.438 involves not damaging the pleura of the remaining pulmo-
COPD (presence) 1.68 0.34–7.72 0.512 nary lobe when dividing the incomplete interlobular fissure
Interstitial pneumonia (presence) 8.08 0.33–2.97 0.167 in pulmonary lobectomy. Moreover, pulmonary fistula is
Steroid therapy (presence) 0.88 0.01–3.15 1.000 also a complication that can be prevented by intraoperative
Diabetes mellitus (presence) 1.22 0.41–3.31 0.711 surgical techniques [13]. The following points are consid-
Tumor size (> 30 mm) 1.63 0.71–3.72 0.242 ered important when using an automatic linear staple device.
Histology (adenocarcinoma) 1.06 0.35–3.53 0.147 First, separate the interlobular fissure to a depth that does
Approach (c-VATS) 1.44 0.41–6.04 0.575 not damage the pleura of the remaining pulmonary lobe.
Additional PGA 3.18 0.24–36.82 0.362 This prevents excessive tension on the pulmonary tissue that
Additional fibrin glue 1.16 0.12–14.00 0.900 could lacerate the lung tissue. Second, select a stapler device
Stapler with PGA 0.38 0.17–0.83 0.015* of appropriate height. Third, in cases with damage to the
residual pulmonary pleura, division of the interlobular fis-
*p < 0.05
sure is performed on the remaining pulmonary lobe side so
as to avoid leaving a damaged lesion. By paying attention
matched pairs of 125 patients from the stapler and stapler to these above points, pulmonary fistula can be prevented
with PGA groups, and the incidence of postoperative air to some extent. Although pulmonary fistula caused by sta-
leakage was significantly lower in the stapler with PGA pler needle holes in fragile tissues such as pulmonary tis-
group than in the stapler group. On logistic regression analy- sue can be prevented, pulmonary fistula caused by cracks
sis, stapler with PGA was demonstrated to be an independent in the vicinity of the staple line (e.g., fibrotic pulmonary
factor for reducing postoperative air leakage on pulmonary parenchyma) cannot be prevented even when using the
lobectomy. This result indicates that using the stapler with stapler with PGA. No significant difference in the popula-
PGA for dividing incomplete interlobular fissure on pulmo- tion of COPD and IP were seen between both groups after
nary lobectomy in patients with NSCLC reduces postopera- propensity score matching, suggesting that the bias in the
tive air leakage. fragility of lung tissue that causes leakage near the staple
Several reports have examined the usefulness of stapler line would be comparable between with and without PGA
with PGA in the area of gastroenterology [11, 12]. However, groups. However, our study actually demonstrated decreased
while the stapler with PGA is used for pulmonary wedge the incidence of pulmonary fistula in the stapler with PGA
resection with fragile or fibrotic pulmonary parenchyma group. This result indicated the utility of using a stapler with
to prevent air leakage, the effect of stapler with PGA for PGA in preventing leakage, especially air leakage from the
dividing the incomplete interlobular fissure in pulmonary hole of stapler needle. For these reasons, the occurrence
lobectomy has not been clarified. If fragility of the lung tis- of pulmonary fistula cannot be completely controlled, but
sue is predicted before or during surgery, a PGA automatic using a stapler with PGA decreased the incidence of pul-
suturing device can be used alone in the adapted cases. monary fistula in this study. However, pulmonary fistula is
Although pulmonary fistula is considered less likely to occur thought to be influenced by surgeon factors [13], and only
based on intraoperative findings, several cases have shown two expert surgeons currently perform pulmonary lobectomy
Table 4 The mean cost of Stapler (n = 125) Stapler with PGA (n = 125) p value
stapler and additional PGA
and fibrin glue in both stapler Additional management
and stapler with PGA group on
PGA 6793.6 ± 4422.9 5404.0 ± 4809.4 0.019*
c-VATS lobectomy in patient
with lung cancer Fibrin glue 25,491.0 ± 16,914.7 19,924.0 ± 18,314.9 0.014*
Stapler 252,576.0 ± 98,800.2 297,859.2 ± 138,818.5 0.012*
Total 284,860.6 ± 103,539.8 323,187.2 ± 136,085.9 0.059
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