FIBRIN SEALANT ENABLES TUBELESS PERCUTANEOUS STONE SURGERY

0022-5347/04/1721-0166/0 THE JOURNAL OF UROLOGY® Copyright © 2004 by AMERICAN UROLOGICAL ASSOCIATION

Vol. 172, 166 –169, July 2004 Printed in U.S.A.

DOI: 10.1097/01.ju.0000129211.71193.28

FIBRIN SEALANT ENABLES TUBELESS PERCUTANEOUS STONE SURGERY MARK W. NOLLER, STEVEN M. BAUGHMAN, ALLEN F. MOREY

AND

BRIAN K. AUGE*

From the Urology Service, Brooke Army Medical Center, Fort Sam Houston, Houston and Department of Urology, Wilford Hall Medical Center, Lackland Air Force Base, San Antonio, Texas, and Department of Urology, Naval Medical Center (BKA), San Diego, California

ABSTRACT

Purpose: Fibrin sealant has been demonstrated to be safe and effective as a hemostatic agent and urinary tract sealant. We assessed the ability of fibrin sealant to facilitate tubeless management after uncomplicated percutaneous nephrolithotomy (PCNL). Materials and Methods: Eight consecutive patients underwent single access tubeless PCNL for renal calculi in a total of 9 renal units in a 2-month period. An additional patient with distal ureteral obstruction underwent antegrade ureteroscopy for an 8 ⫻ 8 mm distal ureteral stone. Average patient age was 47 years and mean stone size was 3.37 cm2 (range 0.64 to 9.90). Following complete stone clearance a Double-J (Medical Engineering Corp., New York, New York) ureteral stent was placed antegrade and 2 cc HEMASEEL APR (Haemacure Corp., Sarasota, Florida) fibrin sealant was injected under nephroscopic or fluoroscopic visualization into the parenchymal defect just within the renal capsule. Preoperative and postoperative hematocrit (HCT) was determined. Computerized tomography was performed on postoperative day 1 or 2 to evaluate retained stone fragments, perinephric fluid and urinary extravasation. Results: In the 10 renal units treated via this tubeless technique no intraoperative or postoperative complications were noted. Average hospital stay was 1.1 days. All patients were discharged home on postoperative day 1 except 1 undergoing asynchronous bilateral PCNL on consecutive days. The mean intraoperative change in HCT was 2.8%. There was no significant change in HCT on postoperative day 1. No patient required transfusion. Seven renal units and 1 ureteral unit had no residual stone fragments for a complete stone-free rate of 80%. No gross leakage was observed on dressings and postoperative computerized tomography failed to demonstrate urinary extravasation. Conclusions: Tubeless PCNL using fibrin sealant at the renal parenchymal defect appears to be safe and feasible. Further experience is necessary to determine the role of fibrin sealant in percutaneous renal surgery. KEY WORDS: kidney; kidney calculi; fibrin tissue adhesive; nephrostomy, percutaneous

Percutaneous nephrolithotomy (PCNL) has become the standard of care for large renal calculi. Most procedures are performed with a nephrostomy tube, which is maintained for several days postoperatively to aid in hemostasis, ensure proper renal drainage and facilitate easy access if additional procedures are required. Quite frequently nephrostomy tubes are complicated by flank discomfort and urinary extravasation around the catheter, leading to distress for the patient, their families and nursing personnel. Decreasing tube size from 22Fr to 10Fr appears to have limited usefulness in symptom control in the immediate postoperative period.1 Tubeless PCNL in select patients has been demonstrated to decrease postoperative discomfort and improve patient satisfaction without compromising safety.2– 4 Fibrin sealant has proved to be safe and effective for controlling hemorrhage from traumatized kidneys in animal models and human subjects.5 It has also been used in several urological procedures, such as fistula closure and iatragenic ureteral or bladder injury repair, radical prostatectomy and pyeloplasty, to pre-

vent urinary leakage.6 We assessed the ability of fibrin sealant to facilitate tubeless PCNL in select patients by preventing urinary extravasation and promoting early hospital discharge without the inconvenience of urinary leakage from the access site.

MATERIALS AND METHODS

Patients. Eight consecutive patients underwent single access tubeless PCNL in a total of 9 renal units in a 2-month period. An additional patient underwent antegrade ureteroscopy for an obstructing 8 ⫻ 8 mm distal ureteral stone that had been previously managed unsuccessfully by a retrograde approach. Mean patient age was 47 years old (range 29 to 59) and mean stone size was 3.37 cm2 (range 0.64 to 9.90) (see table). In addition to the patient with the ureteral stone, 4 patients had stones located in the renal pelvis, 2 had inferior pole stones, and 1 had stones at the ureteropelvic junction and within the renal pelvis. One patient had an inferior pole partial staghorn calculus. Operative technique. In all 10 renal units percutaneous access was attained by interventional radiology using inferior pole or interpolar access. Balloon dilation was performed to 30Fr in all patients with renal calculi, which facilitated advancement of the standard nephrostomy access sheath. The patient undergoing antegrade ureteroscopic stone fragmentation had a 16Fr vascular access sheath advanced to the

Accepted for publication February 27, 2004. The views expressed in this manuscript are those of the authors and do not reflect the official policy of the United States Navy, United States Army, United States Air Force, Department of Defense or the United States Government. * Correspondence: Department of Urology, Naval Medical Center, Building 3, Suite 200, 34730 Bob Wilson Dr., San Diego, California 92134 (telephone: 619-532-7200; e-mail: [email protected]). 166

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FIBRIN SEALANT AND STONE SURGERY RESULTS

Patient demographics Pt No.—Age—Sex

Stone Size (cm2)

Stone Location

Rt ⫹ lt renal pelvis Rt renal pelvis Lt ureteropelvic junction ⫹ lt renal pelvis 4 — 59 — M 0.76 Rt inferior pole 5 — 46 — M 0.91 Lt renal pelvis 6 — 37 — F 3.90 Rt renal pelvis 7 — 47 — M 0.64 Rt distal ureter 8 — 54 — F 9.90 Lt inferior pole, staghorn 9 — 29 — F 2.89 Rt inferior pole * Patient underwent asynchronous bilateral procedures on consecutive days. 1 — 48 — F* 2 — 56 — F 3 — 46 — M

3.08, 2.72 7.42 1.46

level of the mid ureter to facilitate insertion and advancement of the flexible ureteroscope. The Lithoclast Ultra (Boston Scientific Corp., Natick, Massachusetts), a combination pneumatic/ultrasonic intracorporeal lithotrite or a holmium laser were the instruments of choice for fragmenting and/or extracting calculi. Following complete stone clearance and nephrostogram a Double-J stent was placed antegrade under fluoroscopic guidance. The access sheath was withdrawn to the junction of the renal parenchyma and collecting system under direct nephroscopic visualization. A 7-inch 18 gauge spinal needle attached to a dual applicator syringe was used to inject 2 cc HEMASEEL APR without interruption into the renal parenchyma between the collecting system and renal capsule (figs. 1 and 2). After removing the needle and safety wire the wound was closed with a single 2-zero nylon suture and dressed with a sterile 2 ⫻ 2 gauze. Postoperative assessment. A complete blood count was obtained in the recovery room and on postoperative day 1 except in the patient who underwent bilateral PCNL on consecutive days. All patients received intravenous hydration and Foley catheter bladder drainage, which was discontinued the morning after surgery. Imaging on the morning of postoperative day 1 included noncontrast spiral computerized tomography (CT) of the abdomen and pelvis (stone protocol) to assess residual stone fragments, followed by a 7-minute post-intravenous contrast scan of the kidneys to demonstrate urinary extravasation. If extravasation was identified, plans for later removal of the stent (ie after an additional 7 to 10 days in situ) was made following subsequent CT. Subjective assessment of wound drainage was made at patient examination on postoperative day 1. Patients were discharged home with instructions to return in 3 to 5 days for stent and suture removal.

FIG. 1. Fibrin sealant applicator is injected through percutaneous sheath. Components require mixing and preparation time of approximately 20 minutes.

No intraoperative or postoperative complications were noted. The mean intraoperative change in hematocrit was 2.8% and no patients required transfusion. Serum hematocrit remained unchanged on postoperative day 1. Noncontrast CT demonstrated all patients to be stone-free except 2 (80%) with fragments less than 3 mm remaining. Excretory CT failed to reveal urinary extravasation in all patients (fig. 3). One patient was noted to have a small subcapsular hematoma but remained asymptomatic. No gross leakage was noted on dressings on postoperative day 1. All patients were afebrile, ambulating, tolerating a regular diet and voiding without difficulty within 24 hours after surgery. Pain was well controlled by oral pain medication (mean 19 mg morphine equivalents hospitalization, range 2 to 44 mg morphine). Patients were discharged home on postoperative day 1, except 1 patient undergoing asynchronous bilateral PCNL on consecutive days, resulting in a mean hospital stay of 1.1 days. No complications or rehospitalizations were noted after discharge home. DISCUSSION

Due to the risk of potential complications following PCNL, including hemorrhage and edema with resultant urinary obstruction, nephrostomy tube (PCN) placement is standard practice. Without external drainage these complications could lead to the extravasation of urine and blood through the fresh nephrostomy tract and into the retroperitoneum, creating a nidus for bacterial growth, thereby, increasing the risk of sepsis.7 While PCNs aid in the control of bleeding from the nephrostomy tract, facilitate repeat access to the collecting system if secondary PCNL is required and provide continuous unobstructed drainage of urine,7 they are commonly recognized to promote urinary extravasation and postoperative discomfort, and prolong the hospital stay.3 Investigators have observed the efficacy and safety of performing tubeless PCNL in uncomplicated cases. Lojananpiwat et al treated 37 patients with the tubeless PCNL technique using an externalized ureteral stent for 48 hours to ensure unobstructed antegrade urine flow.4 None of the patients required blood transfusion or treatment for urinary obstruction after ureteral stent removal. Patients requiring multiple accesses or second look procedures, or those with evidence of significant perforation or hemorrhage were not deemed to be candidates for tubeless PCNL. Limb and Bellman reported similar results in a study of 112 patients who underwent tubeless PCNL, including percutaneous stone extraction (mean stone burden 3.30 cm2) in 86 and antegrade endopyelotomy in 26.3 Five patients required transfusion and 1 had a renal pseudo-aneurysm, which was successfully treated with selective angiographic embolization. The overall success rate and hospital stay for stone and endopyelotomy cases were 93% and 1.25 days, and 89% and 1.56 days, respectively. Selecting the appropriate patients for a tubeless technique can be difficult because no guidelines have yet been established. This review focuses on single access PCNL procedures with a relatively small stone burden. However, 1 patient had a lower pole partial staghorn calculus cleared completely at a single access and another with bilateral stones underwent asynchronous bilateral PCNL on consecutive days. Thus, since the majority of our patients had a small stone burden and single access tract, our recommendation would be to limit the use of a tubeless approach to straightforward patients until further prospective, randomized studies are completed and additional experience is gained. Fibrin sealant has been used in all surgical disciplines for its hemostatic and sealant properties, urology notwithstanding. The application of fibrin sealant to capsulotomies in simple retropubic prostatectomy cases has facilitated the

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FIG. 2. A, intraoperative photo demonstrates fibrin sealant administration through percutaneous sheath. Patient underwent flexible antegrade ureteroscopy and laser stone fragmentation via 16Fr sheath. B, fluoroscopic image shows applicator needle traversing sheath to collecting system-medullary junction level as sheath is simultaneously withdrawn. Inset, nephrostogram in same patient.

FIG. 3. CT on postoperative day 1 after intravenous contrast administration and 7-minute delay reveals no contrast extravasation along tract (arrow).

performance of the procedure without pelvic drain placement.8 This technique decreased the average hospital stay compared to the procedure without fibrin sealant. Baughman et al successfully used fibrin sealant through a percutaneous approach to terminate refractory urinary extravasation from a renal gunshot wound after several open and endourological methods had failed for more than a month.9 Fibrin sealant has been used successfully in patients following percutaneous nephrolithotomy. Pfab et al administered a collagen fibrin adhesive to the nephrostomy tract during the placement of a 5 or 10Fr PCN.10 Excellent hemostasis was noted in all 26 cases, decreasing the risk of “protracted venous or arterial hemorrhage from the parenchymal canal” and obviating the need for larger nephrostomy tubes.10 Investigators have successfully used 2-octyl cyanoacrylate, an extracorporeal tissue bond, to seal wound edges and prevent urinary extravasation following PCN removal 1 to 16 days after uncomplicated PCNL. However, this tissue adhesive was not injected into the tract, but rather placed superficially onto the reapproximated epidermal edges.11 Mikhail et al reported the usefulness of fibrin sealant in patients undergoing tubeless PCNL, retrospectively comparing 20 who received fibrin sealant to 23 who did not during

tubeless PCNL.12 Average hospital admission was slightly less in the fibrin than in the control group but no difference was noted in hematocrit change or analgesic use between the 2 groups. A total of 17 patients in the fibrin sealant arm of the study underwent postoperative CT 1 to 3 weeks after surgery. No patients were found to have complications arising from the administration of fibrin sealant or evidence of fibrin along the PCNL tract. Perhaps the delay in obtaining postoperative imaging of 1 to 3 weeks may have confounded the ability to demonstrate radiographically the true effectiveness of fibrin sealant for limiting urinary extravasation and bleeding. All 9 patients in our current series underwent CT on postoperative day 1 to evaluate residual stone fragments on noncontrast images. Urinary extravasation from the PCNL tract was also assessed on excretory phase contrast enhanced CT of the kidneys. The exception was 1 patient who underwent asynchronous bilateral PCNL on consecutive days. In this woman CT was performed the day after the second PCNL. None of the patients experienced urinary extravasation less than 24 hours after the procedure and all were ambulating, and had stable hematocrit and minimal pain. All were discharged on postoperative day 1. Our report further adds to the literature regarding the safety of performing tubeless PCNL and suggests that fibrin sealant administered at the conclusion of uncomplicated tubeless percutaneous renal surgery is an effective way of limiting patient morbidity from urinary extravasation or hemorrhage. CONCLUSIONS

Tubeless PCNL using fibrin sealant at the renal parenchyma defect appears to be safe and well tolerated without associated morbidity. Moderate size stones treatable through a single access sheath appear to be most amenable to tubefree surgery at this time. Prospective, randomized studies comparing the tubeless PCNL procedure with and without fibrin sealant are warranted to evaluate further the role and efficacy of fibrin sealant in percutaneous renal surgery. REFERENCES

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9. Baughman, S. M., Morey, A. F., van Geertruyden, P. H., Radvany, M. G., Benson, A. E. and Foley, J. P.: Percutaneous transrenal application of fibrin sealant for refractory urinary leak after gunshot wound. J Urol, 170: 522, 2003 10. Pfab, R., Ascherl, R., Blumel, G. and Hartung, R.: Local hemostasis of nephrostomy tract with fibrin adhesive sealing in percutaneous nephrolithotomy. Eur Urol, 13: 118, 1987 11. Sofer, M., Greenstein, A., Chen, J., Nadu, A., Kaver, I. and Matzkin, H.: Immediate closure of nephrostomy tube wounds using a tissue adhesive: a novel approach following percutaneous endourological procedures. J Urol, 169: 2034, 2003 12. Mikhail, A. A., Kaptein, J. S. and Bellman, G. C.: Use of fibrin glue in percutaneous nephrolithotomy. Urology, 61: 910, 2003