Percutaneous transhepatic biliary tract embolization using gelatin sponge

Abstract

Background

Percutaneous biliary drainage (PTBD) is a necessary procedure in several benign and malignant conditions. After PTBD removal biliocutaneous fistula is a rare but potential complication. Different embolization agents have been used for transhepatic catheter tract embolization in the past, while there is only little experience using gelatin sponge for this procedure.

Purpose

To evaluate the feasibility and safety of PTBD tract embolization with gelatin sponge.

Material and Methods

Between July 2008 and August 2017, 98 patients have been treated with PTBD access embolization using gelatin sponge. PTBD was performed in patients with malignant (67%) or benign (33%) bile duct obstruction. Outcome measures included technical success (complete cessation of bile flow out of the percutaneous access tract), clinical success (intermediate and long-term absence of biliocutaneous fistula, absence of right upper quadrant pain as typical symptom for bile leakage into the peritoneal cavity and absence of hemorrhage out of the catheter tract during follow-up inspections), and the rate of major and minor complications.

Results

Technical success with effective control of bile flow out of the percutaneous access tract was achieved in 97/98 patients (99.0%). Clinical success attributed to gelatin sponge embolization was documented in 96/98 procedures (98.0%). In one case, slight bleeding out of the percutaneous drainage tract occurred after drainage removal and embolization of the access tract. Bleeding was self-limiting; no blood transfusion or surgical intervention was necessary.

Conclusion

PTBD tract embolization with gelatin sponge is a feasible and safe method with a low rate of therapeutically relevant complications.

Keywords

Biliary angiography interventional drainage embolization percutaneous

Introduction

Percutaneous transhepatic biliary drainage (PTBD) is an invasive method with a relatively high tract complication rate of up to 20% (1); it may comprise biliomas, cholangitis, leakage with bile peritonitis, sepsis, hemorrhage, pain, pancreatitis, or biliocutaneous fistula. All those potential complications may also occur after removal of the PTBD, even if there is sufficient bile flow into the downstream. However, all those events must be considered as rare in the setting of post tract embolization without a persisting bile obstruction (2).

To prevent some of those clinically relevant events subsequent to drainage removal, various embolization agents have been utilized for catheter tract closure (7 –12). In this context, embolization has been frequently performed using liquid agents such as cyanoacrylates, coils, and vascular plugs as mechanical occlusion devices as well as a mixture of different agents (11,12), while there is only scarce information utilizing gelatin sponge for this procedure.

To address the need for more data, we evaluated our experiences with PTBD access tract embolization using gelatin sponge with a special focus on the rate of complications.

Material and Methods

Patients

We retrospectively reviewed medical records and identified 98 patients who had undergone transhepatic tract embolization using gelatin sponge after removal of PTBD in our department between July 2008 and August 2017. The age range of patients was 30–91 years (average age = 66.7 years). The study population included 34 women (35.7%) and 64 men (65.3%). In most of these cases, the repeated treatment with PTBD was due to progressive malignant disease. In 67.0%, PTBD was performed due to malignant, mainly caused by pancreatic cancer (23.7%) and cholangiocellular carcinoma (21.7%). Benign reasons for PTBD were cholelithiasis (7.2%) and benign tumors (8.1%) in the majority of cases. All patients were examined and treated as part of routine care and gave informed consent before the intervention. The local institutional review board waived its approval.

Technique

All interventions were performed under local anesthesia. Initially, contrast agent was injected over the drainage catheter under fluoroscopic control to make sure the extraction of drainage was indicated. In this context, the absence of cholestasis or bile leakage had to be verified. A further criterion was the proper runoff into the small intestine via the ductus hepaticocholedochus or biliodigestive anastomosis to prevent recurrence of cholestasis. For PTBD extraction, a standard hydrophilic 0.035-inch guide wire was placed through the drainage catheter beyond the papilla duodeni major or biliodigestive anastomosis, respectively. After removing the drainage, an 8–11 F sheath (Radifocus, Terumo, Tokyo, Japan) was inserted using the Seldinger technique and the hub including the hemostatic valve and side port were cut, resulting in a simple lumen to the intrahepatic access tract. After that, two different techniques of embolization were applied. The preference of each embolization technique was at the discretion of the interventional radiologist. As a first method, gelatin sponge pads (Gelita Medical, Eberbach, Germany) were formed to torpedoes by cutting small stripes of 0.8 × 0.5 × 0.1 cm in size and rolling them tightly into a tapered configuration fitting the size of the used sheath. The insertion into the catheter tract was performed by carefully pushing the torpedoes through the sheath using the dilator while extracting the sheath successively. This approach was executed under fluoroscopy control to identify the intrahepatic location when releasing the gelatin foam torpedoes via the sheath. An example of the embolization technique is provided in Fig. 1.

Fig. 1.

Pictorial description of one of the two used methods of percutaneous transhepatic tract embolization. After placing a standard hydrophilic 0.035-inch guide wire through the drainage catheter and removal of the drainage catheter, an 8–11 F sheath is inserted and the hub with hemostatic valve as well as side port is cut. After that, gelatin sponge pads (Gelita Medical, Eberbach, Germany) are cut into small stripes (a) and formed to torpedoes by rolling them tightly into tapered configuration (b, c). Catheter tract embolization is performed by carefully pushing the torpedoes through the sheath with the dilator while successively extracting the sheath under fluoroscopy control (d).

For the second technique, gelatin sponge torpedoes were formed from small cut stripes of hemostatic gelatin sponge (Ethicon, Somerville, MA, USA) of 7 × 5 × 0.1 cm in size. After carefully attaching the torpedo at the top of a 10-mL syringe filled with saline, a metal cannula was introduced into the sheath and the torpedo was carefully flushed into the access tract. This procedure was repeated multiple times, depending on the size of the catheter tract, while cautiously retracting the sheath. At the end of both techniques, when the skin was reached, the sheath was removed and the puncture tract was inspected for external bile or blood flow. A manual compression of the access tract for 2 min was performed and, after a repeated check-up, a sterile bandage was applied.

Study endpoints

Primary endpoints of our study were technical success, clinical success, and rates of minor and major complications. Technical success was determined as the efficient closure of the transhepatic access tract and was documented by the absence of cutaneous bile flow. Clinical success was determined as intermediate and long-term persistence of technical success and included the absence of biliocutaneous leakage, the absence of right upper quadrant pain as a typical symptom for bile leakage into the peritoneal cavity (2) as well as the absence of hemorrhage out of the catheter tract during follow-up inspections.

Complications of treatment were classified based on outcome according to the reporting standards of the Society of Interventional Radiology (16). Minor complications included those resulting in no therapy and no consequence (class A) or nominal therapy and no consequence including overnight admission for observation only (class B). Major complications included those that required therapy or minor hospitalization <48 h (class C); those that required major therapy, unplanned increase in level of care, or prolonged hospitalization for >48 h (class D); those that resulted in permanent adverse sequelae (class E); and those that resulted in death (class F).

Follow-up

Peri- and post-interventional complications at the embolized access site were documented in the first 24 h until the last documented day of hospitalization. This could be the date of regular hospital discharge, of routine follow-up control in the outpatient clinic or patient´s death. Mean follow-up time was 361 days. During hospitalization, the general condition of the patient and signs of abdominal pain or local or systemic infection were assessed. Signs of infection were based on clinical and laboratory controls (e.g. body temperature, C reactive protein, leukocyte levels, and cholestasis parameters).

Owing to their underlying disease, the patients were followed with irregular clinical visits, usually depending on the concepts in our medical and visceral surgery department. In this context, follow-up imaging was also available in a majority of patients (n = 60) and included computed tomography (CT) in 28 patients, ultrasound in 20 patients, magnetic resonance imaging (MRI) in eight patients, and PTC in four patients. Patients were advised to immediately contact the outpatient clinic at the onset of new or worsening symptoms.

Statistical analysis

Descriptive data are presented as arithmetic means with standard deviation and range, if appropriate; categorical data are given as counts and percentages. Statistical analysis was performed with specialized computed algorithm (Microsoft Excel 2016, IBM SPSS Statistics 24, Stata 15.1). Fisher’s exact test and exact logistic regression were used to analyze the dependence of characteristics. Differences are considered statistically significant when P < 0.05.

Results

Percutaneous transhepatic biliary tract embolization using gelatin sponge was successfully performed in 97/98 patients (99.0%). In one case, slight hemorrhagic bile flow occurred that was self-limiting after 2 h of manual compression. Technical success of PTCD tract embolization was 98.4% in malignant cases and 100% in benign cases (P > 0.05); technical success of PTCD tract embolization via left hepatic lobe was 100% (10/10) and 98.9% (87/88) via right hepatic lobe. These differences were not statistically significant (P > 0.05). Technical success did not significantly differ when comparing drainage sizes ≤10 F (98.8%) versus >10 F (100%) (P > 0.05). Details pertaining the technical success are given in Table 1.

Table 1.

Distribution of technical success dependent on the primary diagnosis, PTBD approach side, PTBD catheter size (F), and stent implantation.

	Sum of interventions	Technical success
		Successful		Not successful
		n	%	n	%
Sum (n = 111)	98	97	99.0	1	1.0
Diagnosis
Malignant	64	63	98.4	1	1.6
Benign	34	34	100.0	0	0.0
PTBD approach
Right	88	87	98.9	1	1.1
Left	10	10	100.0	0	0.0
PTBD size (F)
8.5	65	64	98.5	1	1.5
10.2	21	21	100.0	0	0.0
12	4	4	100.0	0	0.0
14	8	8	100.0	0	0.0
Stent
No stent	58	58	100.0	0	0.0
Stent	40	39	97.5	1	2.5

Concerning the analysis whether stent implantation may have influenced the technical result, there was no significant difference between patients without stent implantation (100%, 58/58 cases) and those with stent implantation (97.5%, 39/40 cases) (P > 0.05).

Clinical success attributed to PTBD tract embolization with gelatin sponge (in terms of intermediate and long-term absence of biliocutaneous leakage, absence of right upper quadrant pain, and absence of hemorrhage out of the catheter tract) was documented in 96/98 procedures (98.0%). One patient with cholangiocellular carcinoma and biliodigestive anastomosis as well as central tumor stenosis developed a biliocutaneous fistula 13 days after catheter tract embolization, which could be treated successfully by performing a second PTCD via the old transhepatic drainage tract. In a second patient with duodenal cancer, Whipple surgery, and PTBD due to leakage of the pancreaticojejunostomy, a delayed biliocutaneous fistula occurred six years after transhepatic drainage tract embolization. This extracorporeal biliary leakage appeared in the context of subdiaphragmatic abscess and fistula along the former drainage tract. CT-controlled percutaneous drainage was performed and led to complete regression of the fistula.

Clinical success was achieved in 96.9% of patients with a malignant diagnosis and in 100% of patients with a benign diagnosis. With catheter tract embolizations, 86/88 (97.7%) via the right hepatic lobe and 10/10 (100%) via the left hepatic lobe approach were clinical successful. Drainage sizes ≤10 F could be successfully treated with catheter tract embolization in 85/86 of cases (98.8%), sizes >10 F in 11/12 of cases (91.7%). In cases with stent implantation, there was a clinical success rate of 97.5% (39/40 cases), while without stent implantation a success rate of 98.3% (57/58) was reached. These differences were not statistically significant (P > 0.05). Data concerning the clinical success are presented in Table 2.

Table 2.

Distribution of clinical success dependent on the primary diagnosis, PTBD approach side, PTBD catheter size (F), and stent implantation.

	Sum of interventions	Clinical success
		Successful		Not successful
		n	%	n	%
Sum (n = 111)	98	96	98.0	2	2.0
Diagnosis
Malignant	64	62	96.9	2	3.1
Benign	34	34	100.0	0	0.0
PTBD approach
Right	88	86	97.7	2	2.3
Left	10	10	100.0	0	0.0
PTBD size (F)
8.5	65	64	98.5	1	1.5
10.2	21	21	100.0	0	0.0
12	4	4	100.0	0	0.0
14	8	7	87.5	1	12.5
Stent
No stent	58	57	98.3	1	1.7
Stent	40	39	97.5	1	2.5

Embolization procedures were generally well tolerated. The overall rate of complications for the study group was 8.1% (8/98 procedures), with a major complication rate of 6.1% (6/98 procedures) and a minor complication rate of 2.0% (2/98 procedures) (Table 3).

Table 3.

Minor and major complications within the 30 days morbidity based on SIR “Classification System for Complications by Outcome.”

			n	%	Sum (%)
Minor complications	A	–	0	0	2.0
Minor complications	B	Minor fever	2	2.0
Major complications	C	Cholangitis	3	3.1	6.1
	C	Bilioma	1	1.0
	D	–	0	0.0
	D	Hemorrhage	1	1.0
	E	Tract seeding	1	1.0
	F	–	0	0

Minor complications graded as class B included mild fever in two cases that was controlled by antibiotic therapy. In those two patients, fever was not due to cholangitis, since the documented liver parameters were not elevated after intervention. A major complication class E was observed in one patient who experienced tract seeding 12 months after the embolization procedure. A major complication categorized as class D occurred in one patient who developed arterial hemorrhage immediately after embolotherapy. Hemorrhage was successfully treated by TAE with microcoils. A major complication class C was observed in one patient who developed bilioma that did not require therapy. Three further patients experienced a major complication class C; those patients had cholangitis that was successfully treated by antibiotics.

Discussion

The present study was performed to evaluate feasibility and safety of PTBD catheter tract embolization with a gelatin sponge. With a technical success rate of 99.0% and clinical success rate of 98.0%, this technique can be adjudged as convenient and safe in preventing bile leak complications after transhepatic interventions.

PTBD with or without stent implantation is, per se, an established method and indicated in several malignant and benign conditions leading to biliary obstruction or biliary leakage when an endoscopic approach for treatment of the biliary tract is technically not possible, for example due to tumor compression or post-surgical changings in anatomy (3,4).

However, as a procedure with certain degree of invasiveness, and since a communication between the intrahepatic bile system, the peritoneum and the cutis is created by the catheter access tract, there is potential for biliary or blood leakage especially after removal of the drainage catheter. Beside the resulting decrease in quality of life, this condition has the potential of severe complications, such as life-threatening biliary peritonitis and significant pain (1,5 –7). Percutaneous transhepatic tract closure techniques significantly showed reduction of those post-interventional complications (8). In the past, embolization of transhepatic catheter tract has been performed using different embolization agents.

Cyanoacrylate utilization in tract embolization might be effective, but also includes the risk of glue migration, as well as catheter tip adherence (9 –12). Moreover, cyanoacrylates are suspected to offer an ideal surface structure for bacterial colonization, which can result in localized abscesses (13).

Studies showed that coils or Amplatzer vascular plugs as mechanical embolization agents are clinically effective and can be placed precisely (14,15). Nevertheless, as permanent agents, both carry the risk of infection (16) or migration; furthermore, they cause artefacts in the later CT or MR examinations and, in case of necessary reintervention, may make it difficult to create a new approach. In addition, both embolization agents are comparably expensive.

In our study, catheter tract closure was performed with gelatin sponge torpedoes as a non-permanent embolization agent, which enables vessel or catheter tract occlusion lasting 3–6 weeks (17). To date, few data exist concerning gelatin foam catheter tract embolization in the actual clinical literature. Gelatin sponge in general is a reliable embolization agent that has been used successfully in vascular interventions (18,19) and for closure of percutaneous bioptic puncture tracts (20) with a high level of biocompatibility (21). Gelatin foam pads are low in cost, widely available, and can be easily modified into the desired size (22).

Even though it has been postulated that, due to trapped air bubbles, gelatin foam can be related to infection (22), as in other studies (20), only a very small collective of our patients (5/98) appeared to develop related local or systemic infection. Moreover, migration of gelatin foam components in the bile duct, intrahepatic artery, or portal vein with adverse obstruction could not be objectivated in our study, even though these concerns were signified in other studies (14). A reason for this more favorable outcome in our series could be that the application form in terms of torpedoes prevented from non-target embolization in comparison to the particulate or cubic configuration of gelatin sponge.

Furthermore, although bleeding events did not appear after catheter tract embolization in our cohort, other studies reported occasional bleeding occurrences following catheter tract embolization with gelatin sponge (16,23). In this context, the number of applied torpedoes depending on the size of the tract might have played a greater role.

Our results did not show any evidence of relation between procedures success and size of drainage catheter, side of transhepatic approach or the additional placement of biliary stent. Also, even if there was a tendency to a statistically higher technical and clinical success rate in patients with benign disease, the difference appeared not to be significant.

There are three main limitations to this study. First, the study was retrospective and lacked randomization, a reason why we consider the results of our study preliminary. A prospective randomized trial would be beneficial for defining the exact value of PTBD tract embolization with gelatin sponge in comparison to a cohort of patients without any prophylactic access path closure. Second, follow-up in this series could have been biased by the fact that inspection for biliocutaneous fistula was the only technical parameter of success. In this context, an imaging modality like ultrasound would have been helpful to additionally document a successful approach in each patient. Third, a comparison between the two embolization techniques was not performed and should therefore be a subject of future studies.

In conclusion, our study demonstrates that PTBD tract embolization using gelatin sponge is a feasible and safe technique in the prevention of therapeutically relevant complications.

Footnotes

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

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