Is hemostatic agent effective and safe in minimally invasive partial nephrectomy?

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Is hemostatic agent effective and safe in minimally invasive partial nephrectomy?

Renal cell carcinoma (RCC) ranks among the top 10 most common cancers in adults, and partial nephrectomy (PN)—surgically removing the tumor while preserving healthy kidney tissue—is the gold standard for small RCC tumors. In recent years, minimally invasive PN options like robotic-assisted partial nephrectomy (RAPN) and laparoscopic partial nephrectomy (LPN) have gained traction for their shorter recovery times and fewer invasions. But even with these advances, bleeding (intraoperative or post-op) and urinary leakage (UL) remain major risks, affecting up to 9.5% and 4.5% of patients respectively.

To tackle these complications, surgeons often use hemostatic agents (HAs)—biodegradable topical products like fibrin sealants (e.g., TachoSil®) or gelatin matrix thrombin sealants (e.g., FloSeal®)—alongside standard suture-based hemostasis. Surveys show HAs are used in 75–80% of minimally invasive PN cases, usually combined with sutures. Yet, no clear evidence existed to confirm if adding HAs actually improves outcomes.

That’s where a 2022 systematic review and meta-analysis from researchers at Sichuan University’s West China Hospital comes in. Led by Qiong Guo, Yifei Lin, and Ga Liao, the study set out to answer a critical question: Does adding HA to suture hemostasis reduce complications or improve healing compared to suture alone in minimally invasive PN?

What Did the Study Examine?

The team analyzed 10 retrospective cohort studies (involving 1,976 patients) from databases like PubMed, EMBASE, and ClinicalTrials.gov. They compared two groups:

  • Additional HA + suture: Patients who received both suture and HA.
  • Suture alone: Patients who only used suture for hemostasis.

Key outcomes included:

  • Primary: Blood transfusion rate (BTR), urinary leakage (UL), and hemorrhagic complications (HCs—e.g., bleeding, hematoma, hematuria).
  • Secondary: Length of hospital stay (LOS), estimated blood loss (EBL), warm ischemia time (WIT—the time the kidney is without blood flow during surgery), and operative time (OT).

Studies were excluded if they involved open PN, HA-only treatments, or advanced tumors with lymph node involvement. The team assessed bias using the Newcastle-Ottawa Scale and performed subgroup analyses to explore differences by surgical type (RAPN vs. LPN) and HA type (fibrin vs. gelatin matrix thrombin).

Key Findings

Overall, the meta-analysis found no significant differences in BTR, UL, HCs, LOS, EBL, WIT, or OT between the HA + suture and suture-only groups. But when breaking results into subgroups, patterns emerged:

1. Surgical Type Matters

  • LPN: Adding HA significantly reduced UL (3x lower risk) and HCs (4x lower risk) compared to suture alone.
  • RAPN: No benefits—HA + suture showed no improvement in bleeding, leaks, or other outcomes versus suture alone.

2. HA Type Has Small Effects

  • Fibrin sealants: Lowered HCs (50% reduced risk) compared to suture alone.
  • Gelatin matrix thrombin sealants: Shortened operative time by ~25 minutes—but didn’t improve other outcomes.

The team also noted high heterogeneity (variability) in results for EBL, WIT, and OT, likely due to differences in how these metrics are measured (e.g., EBL via weight vs. volume) or defined across studies. Publication bias was low for most outcomes, except WIT (small risk).

Why Do These Results Matter?

The biggest takeaway is that HA benefits depend on the type of minimally invasive PN. For LPN—where surgeons have less precision than RAPN—adding HA to suture helps plug leaks and reduce bleeding complications. But for RAPN, which uses robotic arms for superfine suturing and avoids knot-tying, HA offers no extra value.

Cost is another critical factor. A 2020 study found annual HA costs for RAPN ($1,452) are more than double those for LPN ($627). Since RAPN patients see no benefit from HA, using it adds unnecessary expense—both for patients and healthcare systems. Cutting unnecessary HA use could make RAPN more cost-effective.

Limitations to Consider

Like all studies, this review has gaps:

  • Retrospective design: All included studies looked back at past data, so selection bias (e.g., doctors choosing HA for high-risk patients) can’t be ruled out.
  • Heterogeneity: Differences in surgeon experience, HA dosage, tumor location, and patient health (e.g., anticoagulant use) may have skewed results.
  • Lack of RCTs: No randomized controlled trials (the “gold standard” for evidence) were included, so stronger evidence is needed.

Conclusion

For patients undergoing laparoscopic partial nephrectomy (LPN), adding hemostatic agents to suture hemostasis can safely reduce urinary leakage and bleeding complications—without prolonging operative or ischemic time. For robotic-assisted partial nephrectomy (RAPN), however, hemostatic agents offer no clear benefits and add unnecessary cost.

The study’s authors recommend rethinking routine HA use in RAPN and considering it as a supplement only for LPN. To confirm these findings, future research should focus on prospective RCTs (where patients are randomly assigned to HA + suture or suture alone) to eliminate bias and better assess long-term outcomes.

Qiong Guo, Yifei Lin, Chenyang Zhang, et al. Is hemostatic agent effective and safe in minimally invasive partial nephrectomy? Chinese Medical Journal. 2022;135(17):2116–2118. doi:10.1097/CM9.0000000000001992

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