Modified free pericardial fat pledget technique for intraoperative air leak management in robotic-assisted thoracic surgery

Introduction

Prolonged air leak (PAL) following pulmonary resection is one of the most prevalent complications, and preventing PAL through effective intraoperative lung fistula repair is crucial in thoracic surgery to mitigate postoperative risks (1). However, definitive evidence regarding the optimal technique for intraoperative air leak management remains lacking. Currently, various sealants are employed in pulmonary resection, including fibrin-based products (2), polyglycolic acid (PGA) sheets (3), and free pericardial fat pledget (FPFP) (4,5). Several studies have documented the use of FPFP in video-assisted thoracic surgery (VATS) (4,6-8). We previously reported lung fistula repair using the FPFP in robot-assisted thoracic surgery (RATS) and have adopted this technique in our practice (9). Nevertheless, our conventional FPFP technique required frequent assistance, which contradicts our institutional goal of solo RATS. In addition, prolonged suture handling time and frequent suture entanglement were observed with the conventional FPFP technique. To address these issues, we developed a modified FPFP technique that is simple and allows the entire intrathoracic procedure to be completed by one surgeon. This study evaluated the feasibility of the modified FPFP technique compared with that of the conventional FPFP technique. We present this article in accordance with the STROBE reporting checklist (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-1586/rc).

Methods

Study design

This retrospective study was conducted at Sapporo Medical University Hospital between April 9, 2018, and May 31, 2024. All patient data were extracted from medical records and surgical videos. This study included consecutive patients who underwent anatomical lung resection for primary or metastatic lung cancers requiring intraoperative air leak repair using either the conventional or modified FPFP technique. Wedge resections and benign diseases were excluded. Based on our selection criteria, 36 patients were included in the analysis. The pathological stage of lung cancer was evaluated based on the eighth edition of the Union for International Cancer Control TNM Stage Classification. Patient characteristics, intraoperative findings, and postoperative outcomes were retrospectively analyzed and compared between the two techniques. To evaluate potential confounding by surgeon experience, we recorded whether the operating surgeon was certified as an official RATS proctor at the time of surgery. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. This study was approved by the Sapporo Medical University Hospital Institutional Review Board (No. 322-265, approval date: February 4, 2021) and individual consent for this retrospective analysis was waived.

Surgical technique

Our RATS program was initiated on April 9, 2018, and the modified FPFP suture technique was introduced in 2021. Accordingly, only conventional FPFP technique was performed in the early period (2018–2020) and both techniques were available in the late period (2021–2024). Figure S1 presents the timeline of the RATS program and introduction of the modified FPFP technique at our institution. The surgical procedure was performed using the da Vinci Xi Surgical System (Intuitive Surgical, Sunnyvale, CA, USA). At our institution, RATS is typically conducted via a single utility incision (30–40 mm) at the level of the fourth intercostal space and with four ports, following the 4-arm robotic technique as described by Cerfolio (10). Maryland bipolar forceps for the right hand, fenestrated bipolar forceps for the left, a 30-degree endoscope, and Cadiere forceps (Intuitive Surgical) for the third arm were primarily utilized. The assistant surgeon was positioned ventral to the patient. We frequently divide low-grade incomplete fissures, such as Craig and Walker classification grades 1 and 2, using only Vessel Sealer Extend (Intuitive Surgical) (11). Following pulmonary resection, a water-seal leak test was conducted. Airway pressure was gradually increased from 15 to 20 cm H₂O while observing for air leaks in the lung parenchyma and bronchi. Air leaks were graded using the Macchiarini scale score (MSS) as grades 0 (no leak), 1 (countable bubbles), 2 (stream of bubbles), or 3 (coalesced bubbles) (12). At our institution, intraoperative leak assessment was routinely performed with a water-seal visual scale. Our previous study demonstrated that the VIO soft coagulation system (Erbe Elektromedizin, Tübingen, Germany) is effective for minor air leaks (13). Therefore, if an air leak was detected, soft coagulation sealing using the VIO 300D system (Erbe Elektromedizin) was applied at the surgeon’s discretion. FPFP techniques for pulmonary fistula were performed if the air leak was uncontrolled after soft coagulation, if the air leak was graded as a 2−3 using the MSS, or if the pulmonary fistula was extensive.

Common features of conventional and modified FPFP techniques

Initially, two 1 cm-sized FPFP were used per suture, with the number of pledgets harvested depending on the number of air leaks. The fundamental technique involved closing the visceral pleural defect with a horizontal mattress suture and interposing the defect between the harvested fat pledgets. One of the fat pledgets was pre-attached to the suture extracorporeally. Suturing was primarily performed using Maryland forceps without a needle driver to reduce costs. If the needle control was suboptimal, left-handed fenestrated forceps were employed as an alternative. A subsequent sealing test was conducted to confirm the absence of air leaks, and additional sealants were applied if leaks were detected.

Conventional FPFP technique

As previously reported, a 70-cm length of 4-0 polydioxanone suture (PDS) (SH, double-armed needle) was used (Figure 1) (9). The needles were sequentially passed through the fat and lung parenchyma, followed by suture ligation at the desired length. The suture was cut by an assistant or surgeon using electrocautery or forceps. Four suture deliveries were required between the surgeon and assistant (Video 1).

Figure 1 A 10–15-cm length of 4-0 PDS single-armed suture with a loop for the modified FPFP technique (A). A 70-cm length of 4-0 PDS double-armed suture for the conventional FPFP technique (B). FPFP, free pericardial fat pledget; PDS, polydioxanone suture

Modified FPFP technique

A short suture loop was prepared outside the thoracic cavity using a 4-0 PDS suture (Video 2). A loop was created at the end of the suture to prevent slippage, forming a 10–15 cm single-ended needle (Figure 1). The fat pledgets were then applied to the air leak site and secured using horizontal mattress sutures. Figure 2 and Video 3 demonstrate the details of the procedure. A single-armed suture was first passed through the initial fat pledget once, followed by passage through the lung parenchyma. The suture was then passed through the second fat pledget twice and then returned through the lung parenchyma. Finally, it was again passed through the initial fat pledget and tied down after the needle was removed. The loop was adjustable intracorporeally, allowing the surgeon to release it if necessary (Video 4). Finally, the surgeon cut the suture using electrocautery forceps. Only two suture deliveries were required between the surgeon and assistant.

Figure 2 Modified FPFP technique. Suturing in the order of 1–6 is shown. To close the visceral pleural defect with a horizontal mattress suture, the defect was sandwiched between the harvested fat pledgets. A 4-0 PDS single-armed suture is first passed through the initial fat pledget once, followed by passage through the lung parenchyma. Subsequently, the suture is passed through the second fat pledget twice and then returned through the lung parenchyma. Finally, it is passed again through the initial fat pledget and tied down after the needle is removed. FPFP, free pericardial fat pledget; PDS, polydioxanone suture.

Surgical outcome measures

Pericardial fat harvesting time and total suturing time were measured from the intraoperative videos. The detailed measurement items were defined as follows:

• Harvesting pericardial fat time: from dissection start to completion.
• Total suturing time: from first needle insertion to final tying and handling of the suture.
• Needle handling time: from the first needle insertion to completion of horizontal mattress suturing.
• Suture ligating time: from the start to completion of knot tying.
• Other time (B − C − D): including additional intra- and extra-thoracic maneuvers.

The primary endpoint of this study was total suturing time per leak site, as this represents the overall efficiency of FPFP repair. Secondary exploratory endpoints included needle handling time, suture ligating time, and other time. The total suturing time included only the intracorporeal procedure. “Other time” included needle delivery between the surgeon and assistant, and assistant manipulation (e.g., threading the needle through fat in the conventional method, releasing tangled sutures). Pre-suture thread preparation time was not included, since there was no video recording of the extra-thoracic cavity, and it was not measurable. The occurrences of intraoperative complications, such as suture entanglement and detachment from fat pledgets, were also evaluated. Additionally, we analyzed patient characteristics and intraoperative outcomes (operation time, console time, and blood loss) and evaluated the chest tube duration, postoperative hospital stay, postoperative complications, chest tube re-insertion, re-operation, pleural adhesion therapy, and 30 and 90-day mortalities. PAL was defined as postoperative air leakage lasting ≥5 days.

Statistical analysis

Continuous variables are expressed as the median and interquartile range (IQR), and categorical variables are expressed as counts and percentages. These variables were compared between the conventional and modified FPFP groups using the Mann-Whitney U test and the Fisher exact test or chi-square test.

To account for possible correlations within patients and within surgeons, we also summarized outcomes at the individual patient level by calculating each patient’s median total suturing time and determined whether suture entanglement occurred at least once. Between-group comparisons were conducted using the Mann-Whitney U test for continuous outcomes and Fisher exact test for binary outcomes. For key endpoints, we further estimated median differences and absolute risk differences with 95% confidence intervals (CIs) via bootstrap resampling (10,000 replicates). Because segmentectomy was more frequent in the modified group, we also performed a sensitivity analysis restricted to lobectomy cases, applying the same bootstrap procedures. To address surgeon experience, we recorded whether the operating surgeon was certified as a RATS proctor and carried out sensitivity analyses stratified by certification status. Finally, to examine potential secular trends or learning-curve effects, we defined an “early period” (2018–2020, when only the conventional technique was used) and a “late period” (2021–2024, when both techniques were available) and performed period-adjusted sensitivity analyses. Statistical significance was set at P<0.05. Statistical analyses were conducted using JMP Pro 15 software (SAS Institute Inc., Cary, NC, USA) and EZR (version 1.68; Saitama Medical Center, Jichi Medical University, Saitama, Japan), a graphical user interface for R.

Results

Patient characteristics and surgical outcomes

Patient characteristics and surgical outcomes are summarized in Table 1. Based on our selection criteria, 12 and 24 patients were allocated to the conventional and modified FPFP groups, respectively. There were no patients with missing data. No significant differences were observed between the two groups regarding age, sex, body mass index, height, comorbidities, smoking history, pulmonary function, tumor size, histological type, or pathological stage. Although segmentectomy was performed in eight patients in the modified FPFP group, the difference was not statistically significant (P=0.21). No patient in either group required conversion to VATS or thoracotomy. The operation and console times tended to be shorter in the conventional FPFP group; however, the differences were not statistically significant (P=0.48 and P=0.24, respectively). The blood loss volume was comparable between the two groups.

Suture outcomes

The suture outcomes are summarized in Table 2. Two patients in each group required repairs at two separate air leak sites. The total number of air leaks repaired was 14 and 26 in the conventional and modified FPFP groups, respectively. Regarding the console surgeon, procedures performed by surgeons certified as RATS proctors occurred significantly more frequently in the conventional FPFP group (11 sites, 78.6%) than in the modified FPFP group (10 sites, 41.7%; P=0.043). The distribution of air leak sites did not differ significantly between the conventional and modified groups, with 7 (50%) vs. 9 (34.6%) sites involving lung surface leaks, 4 (28.6%) vs. 11 (42.3%) sites involving staple line leaks, and 3 (21.4%) vs. 6 (23.1%) sites involving dissection or fissure formation sites treated with a Vessel Sealer Extend (Intuitive Surgical), respectively (P=0.60). When grading air leaks, the conventional and modified groups showed MSS 1 at 3 and 8 sites, MSS 2 at 6 and 8 sites, and MSS 3 at 5 and 10 sites, respectively, with no significant differences observed (P=0.70).

Soft coagulation before suturing was similar between the two groups (9 sites, 64.2% and 13 sites, 50% in the conventional and modified groups, respectively; P=0.51). The median harvesting pericardial fat time was comparable between the groups, with 47 (IQR, 41.7–81) sec in the conventional group and 54.5 (IQR, 35.7–82.2) sec in the modified group (P=0.72). The proportion of sites where the fat pledget was pre-attached to the suture extracorporeally by the assistant surgeon was also similar, with 7 (50%) and 12 (46.1%) sites in the conventional and modified groups, respectively (P=0.71).

A comparison of the suturing time between the conventional and modified FPFP groups is shown in Figure 3A-3D. The median total suturing time for the modified group [335 (IQR, 264–440.7) sec] was significantly shorter compared to that of the conventional group [426.5 (IQR, 376–464) sec; P=0.02; Figure 3A]. However, no significant differences were observed in the median needle handling time [147.5 (IQR, 111.7–174.5) vs. 152 (IQR, 114.5–203.7) sec; P=0.65; Figure 3B] or suture ligating time [101 (IQR, 83–120) vs. 82 (IQR, 60–104) sec; P=0.09; Figure 3C]. The modified group showed a significantly shorter median “other time” [94 (IQR, 55–116.2) vs. 184 (IQR, 101.5–238.2) sec; P<0.001; Figure 3D].

Figure 3 Comparison of the suturing time between the conventional and modified FPFP groups. (A) Total suturing time; (B) needle handling time; (C) suture ligating time; (D) other time. FPFP, free pericardial fat pledget.

Suture entanglement occurred at six sites in the conventional group but was absent in the modified group (P<0.001). Entanglements occurred in all cases immediately after the suture was passed from the assistant to the surgeon. The median time was 35.5 (range, 7–64) sec to release the entangled sutures.

After suturing and needle removal in the conventional group, suture detachment from a fat pledget occurred in one site, and it took 156 sec to recover. Successful air leak control was achieved at all sites without additional sealants.

Sensitivity and robustness analyses

The patient-level sensitivity analysis is summarized in Table S1. The modified group’s median total suturing time remained significantly shorter [353 (IQR, 280–415) sec] than in the conventional group [427 (IQR, 382–456) sec; P=0.02]. Entanglement was observed in 6 of 12 patients (50%) in the conventional group but in none of 24 patients in the modified group (P<0.001).

Bootstrap analyses are summarized in Table S2. The median total suturing time was 335 (IQR, 270–428) sec in the modified group versus 426 (IQR, 382–453) sec in the conventional group (P=0.02), with a bootstrap-estimated median difference of −82 sec (95% CI: −164 to −9). Time components for harvesting, needle handling, ligating, and “other” did not differ significantly; their bootstrap 95% CIs all included zero. Entanglements occurred in 42.9% (6/14) of conventional cases vs. 0% (0/26) of modified cases (P<0.001), with a bootstrap-estimated risk difference of −0.38 (95% CI: −0.69 to −0.17).

When restricted to lobectomy cases, the modified technique remained associated with shorter median total suturing time [343 (IQR, 276–435) vs. 434 (IQR, 379–456) sec; P=0.042], with a median difference of −91 sec (95% CI: −169 to −3; Table S3). Entanglements occurred in 6 of 13 lobectomy cases (46.2%) in the conventional group and in none of 17 cases in the modified group (P=0.002), yielding a bootstrap-estimated risk difference of −0.46 (95% CI: −0.74 to −0.18).

Stratified analyses by proctor certification revealed consistent trends between the two groups (Table 3). Among procedures by certified surgeons, median total suturing time was 408 (IQR, 264–474) sec in the modified group vs. 419 (IQR, 382–456) sec in the conventional group (P=0.79). Among non-certified surgeons, time was 296 (IQR, 272–375) vs. 488 (IQR, 428–537) sec (P=0.07). Entanglements were observed only in conventional cases carried out by certified surgeons (5 sites, 45.5%; P=0.03).

Period-adjusted analyses also confirmed robustness of the data (Table 4). In the late period (2021–2024), when both techniques were in use, the modified technique achieved significantly shorter median total suturing time than the conventional technique [335 (IQR, 270–428) vs. 445 (IQR, 404–472) sec; P=0.02]. Entanglements occurred in 4 of 11 conventional cases vs. none of 26 modified cases (P=0.005).

Postoperative outcomes

The postoperative outcomes are presented in Table 5. No significant differences were observed between the two groups regarding chest tube duration, postoperative hospital stay length, or postoperative complications. Two postoperative air leaks occurred in the modified group and both resolved after a single autologous blood patch without progression to PAL. One case of pleuritis was reported in the modified group, which resolved with antibiotic therapy. No patients in either group experienced mortality within 90 days or required chest tube re-insertion or re-operation.

Discussion

Key findings

Suture entanglement near the wound, likely attributable to the multiple needle hand-offs required by the assistant, is a significant limitation of the conventional FPFP technique. This issue increases both the total suturing time and the handling complexity. Even when the surgeon is experienced or certified as a RATS proctor, tangling can still occur, requiring the assistant to remain vigilant. Because some patients had multiple leak sites, analyses based on individual sites may underestimate variance due to within-patient clustering. Our patient-level sensitivity analyses confirmed that the modified technique was associated with significantly shorter total suturing time and no entanglement events compared with the conventional technique, indicating that our main conclusions are robust despite the limitations presented by the small sample size and complete separation in binary outcome data. By reporting bootstrap-estimated median and risk differences along with 95% CIs, we provide estimates of effect size and precision beyond P-values alone, thereby improving interpretability. Although the modified group had a higher frequency of segmentectomy, lobectomy-only analyses yielded consistent results, suggesting that the imbalance in procedure type did not account for the observed differences. Similarly, stratification by proctor certification status proved that surgeon experience or certification could not fully explain the benefit associated with the modified technique. Finally, period-adjusted analyses demonstrated that the beneficial effect of the modified technique persists in the late period, reducing the likelihood that secular trends or learning-curve effects were responsible for our findings.

Moreover, in the conventional method, the entire suture is not always visible either inside or outside the thoracic cavity. The modified FPFP technique addresses this challenge by reducing the number of suture deliveries from four to two. Furthermore, this modified technique offers the advantage of maintaining the entire suture within the visual field. The shorter sutures ensure that the full length remains visible throughout the procedure, thereby minimizing the risk of misidentification and simplifying handling. Eliminating suture entanglement is critical, as unnecessary movements during suture release may pose a risk of secondary injury to the intrathoracic organs. Furthermore, the loop added in the modified FPFP technique prevented suture detachment from the fat pledget during manipulation, offering a distinct advantage. This adjustable loop facilitated intracorporeal adjustments, enhancing surgeon control and efficiency. The release of the loop can be selected according to the preference of the surgeon, and adjustment of the suture length within the thoracic cavity is facilitated, providing an additional benefit. Both techniques were effective for lung fistula repair; however, the modified FPFP technique demonstrated additional advantages, especially for surgeons not certified as RATS proctors. The simplicity and versatility of this technique make it applicable for lung fistula repair and covering the bronchial stump, which is routinely utilized at our institution.

Comparison with similar research

A previous study has highlighted the utility of FPFP owing to its cost-effectiveness compared with biological glue, minimal procedural time, and lack of infection risk (14). Particularly in RATS, fat harvesting is notably easier than that in VATS, enhancing the practicality of this technique. Additionally, lung parenchyma and free fat are flexible tissues, negating the need for a specialized needle driver for needle handling (9). The FPFP can effectively close large bronchopleural fistulas that lead to refractory pneumothorax (8). A previous case report revealed that FPFP remained pathologically as the fat necrosis surrounded by fibrous tissue one year following the initial surgery (7). Additionally, a previous study reported that FPFP significantly reduced PAL compared to PGA sheets (4).

Conversely, fibrin agents and PGA sheets are effective while presenting notable drawbacks (2,3). Fibrin-based sealants are costly, and a minute risk of viral or prion infections exists (15,16). PGA sheets are associated with fibrosis and adhesion around the material, which may complicate re-operations (17). The JCOG0802/WJOG4607L trial demonstrated the benefits of anatomical lung segmentectomy for early-stage non-small-cell lung cancer (18); however, it is necessary to anticipate the possibility of more complete lobectomy following anatomical lung segmentectomy. At our institute, we avoid using fibrin agents or PGA sheets during initial surgeries to minimize adhesion risks, relying solely on the FPFP technique for air leak control. Although the FPFP technique alone is generally sufficient, additional sealants may be considered in cases with extensive repair sites or when the background lung tissue is fragile.

Strengths and limitations

This study has several limitations. First, the sample size was small. Its retrospective nature and single-institutional design introduced risks of selection bias and confounding, and the small cohort size (n=36) further limited its statistical power and generalizability. Therefore, the results should be regarded as exploratory and hypothesis-generating, warranting confirmation in larger, prospective, multi-institutional investigations. Moreover, the limited number of patients reduced the statistical power to detect differences in postoperative complications, raising the possibility of a type II error, whereby clinically meaningful differences may not have reached statistical significance. Second, differences in surgeon experience might have influenced outcomes since only two of the seven surgeons were certified as RATS proctors. Notably, the modified FPFP group included more surgeons with limited RATS experience, which might explain the shorter operation and console times in the conventional FPFP group. Although three postoperative complications were observed in the modified FPFP group, the differences were not statistically significant. Third, this study was not powered for multiple secondary outcomes. Therefore, analyses of procedure-time subcomponents should be considered exploratory, and the conclusions primarily relied on the total suturing time as the predefined primary endpoint. Fourth, variations in techniques, such as soft coagulation sealing and loop release, could have impacted the results. For soft coagulation, our previous experimental studies in mice reported that air leaks were likely controlled by covering the fistula with a fibrin membrane after soft coagulation (19). Of the air leaks graded as a MSS of 2 or 3, 52.9% and 35.3%, respectively, could be controlled with the VIO soft coagulation system alone. Thus, additional procedures are often required for pulmonary fistulas with high scores. Lung parenchyma degeneration using soft coagulation did not affect either of the FPFP techniques. Finally, regarding alternatives, fibrin sealants have been shown to reduce air leak incidence and duration after lung resection in randomized and prospective studies. Several reports have indicated a potential additive benefit when fibrin sealants are combined with bioabsorbable sheets in selected scenarios; however, material-specific performance differs across products (20,21). In our cohort, no cases received fibrin-only or PGA sheet-only management during the study period, which precluded direct in-house comparisons. Therefore, we summarized the published evidence and position FPFP as a step-up option when MSS 2 or 3 leaks persist after soft coagulation or when fistulae are extensive. We believe that further prospective studies directly comparing FPFP with other sealants are needed.

Implications and actions needed

A comparison of the FPFP technique with and without the use of soft coagulation needs to be prospectively validated with a larger sample size in the future. While visual leak grading by MSS is widely used during the saline test, quantitative intraoperative measurement using a mechanical ventilation test, which classifies leaks as mild (<100 mL/min), moderate (100–400 mL/min), or severe (>400 mL/min), may be preferred to standardize treatment thresholds. Likewise, digital chest drainage provides objective postoperative classification criteria (e.g., <50 mL/min for 8 h to declare resolution) (22,23). We did not routinely perform the intraoperative ventilation mechanical test or use postoperative digital drainage; thus, severity grading and treatment decisions were based on visual MSS. Although this reflected real-world practice at the time, future protocols will incorporate quantitative thresholds to improve comparability and external validity.

Conclusions

The modified FPFP technique significantly reduced the total suturing time and prevented suture entanglement compared to the conventional FPFP technique. This novel and straightforward procedure may be suitable for surgeons with limited RATS experience and for use during solo RATS, as it allows surgeons to complete the intrathoracic procedure independently. These findings are hypothesis-generating and warrant further validation in larger and more diverse cohorts.

Acknowledgments

We would like to thank Editage for English language editing.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-1586/rc

Data Sharing Statement: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-1586/dss

Peer Review File: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-1586/prf

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-1586/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. This study was approved by the Sapporo Medical University Hospital Institutional Review Board (No. 322-265, approval date: February 4, 2021) and individual consent for this retrospective analysis was waived.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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