Download A prospective study on radiofrequency ablation locally advanced

Original Article / Pancreas
A prospective study on radiofrequency
ablation locally advanced pancreatic cancer
Riccardo Casadei, Claudio Ricci, Raffaele Pezzilli, Carla Serra, Lucia Calculli,
Antonio Maria Morselli-Labate, Donatella Santini and Francesco Minni
Bologna, Italy
BACKGROUND: Radiofrequency ablation (RFA) has been
suggested as a new treatment option for patients with locally
advanced cancer. This study aimed to prospectively evaluate
the efficacy and safety of intraoperative RFA in patients with
unresectable, locally advanced, non-metastatic carcinoma of
the pancreatic head.
METHODS: RFA was the first step of the surgical procedure
and was carried out on the mobilized pancreatic head followed
by biliary by-pass and gastrojejunal-anastomosis. Intra- and
post-operative morbidity and mortality, performance status,
pain control, quality of life, and survival at 24 months were
evaluated.
RESULTS: Seven patients (3 men and 4 women; median age
66 years, range 47-80 years) were studied and 4 were eligible
for treatment. The RFA procedure was carried out in 3 of the
4 patients; in one patient it was not carried out because of the
upstaging of the neoplasm. In all 3 patients RFA achieved
complete necrosis of the lesion. A biliary fistula developed
7 days after the procedure in one patient; all 3 patients
developed ascites 8.6 days (range 7-9 days) on average after
RFA. All patients died respectively, at 3, 4, and 5 months after
the treatment.
CONCLUSIONS: In our experience, RFA is a feasible procedure,
but it presents a very high rate of postoperative complications.
Moreover, pain control, life quality and survival rate are poor.
The few data suggest no impact on survival.
(Hepatobiliary Pancreat Dis Int 2010; 9: 306-311)
Author Affiliations: Department of Surgery (Casadei R, Ricci C and Minni
F), Department of Internal Medicine and Gastroenterology (Pezzilli R,
Serra C and Morselli-Labate AM), Department of Radiology (Calculli L),
and Department of Pathology (Santini D), S. Orsola-Malpighi Hospital,
University of Bologna, Bologna, Italy
Corresponding Author: Raffaele Pezzilli, MD, Department of Internal
Medicine and Gastroenterology, S. Orsola-Malpighi Hospital, University of
Bologna, Via Massarenti n.9 40138, Bologna, Italy (Tel: +3905163641488;
Fax: +390516364148; Email: [email protected])
© 2010, Hepatobiliary Pancreat Dis Int. All rights reserved.
KEY WORDS: pancreatic neoplasms;
radiofrequency ablation;
survival;
efficacy;
safety
Introduction
A
denocarcinoma of the pancreas is one of the
most aggressive human cancers.[1] Surgical
resection is the only potentially curative
treatment for pancreatic cancer, but at the time of
diagnosis radical surgery is possible in only 5%-25% of
patients, with a 5-year survival rate no more than 29%
in high volume centers.[2] Forty percent of patients with
pancreatic adenocarcinoma have unresectable locally
advanced disease with massive encasement of the major
vessels (the portal and superior mesenteric vein and/
or the superior mesenteric artery and/or the hepatic
artery).[3] Vascular reconstruction in these patients can
be carried out with acceptable morbidity and mortality
without a significant survival benefit.[4] Chemotherapy
generally confers symptomatic improvement in these
patients, improves the quality of life, and prolongs
survival. Chemoradiation appears to be not superior
to chemotherapy.[5] The patients who have undergone
surgery with the purpose of curative resection for
periampullary malignancies, but have been found to
have an unresectable tumor should undergo a surgical
biliary bypass.[6-8] Gastrojejunostomy is better than
stent placement for treatment or prevention of gastric
outlet obstruction in patients with a longer survival
(non-metastatic) who are found to have unresectable
pancreatic head cancer at laparotomy.[9, 10]
Radiofrequency ablation (RFA) is a new, local
thermal therapy used for the palliative treatment of solid
parenchymal tumors.[11-18] RFA appears to be an attractive
option in patients with unresectable, locally advanced
and non-metastatic pancreatic cancer.[19] However, only
306 • Hepatobiliary Pancreat Dis Int，Vol 9，No 3 • June 15，2010 • www.hbpdint.com
Radiofrequency ablation for pancreatic cancer
Table 1. Inclusion and exclusion criteria for eligibility for RFA
Inclusion criteria
ASA status <4
Age greater than 18 years and less than 80 years
Exclusion criteria
No written informed consent
Presence of a pacemaker
No evidence of infection or other clinical conditions which
contraindicate enrollment
Previous surgical intervention, open biopsy or traumatic lesion within
28 days before enrollment
Presence of non-metastatic pancreatic head neoplasm
Other neoplastic disease diagnosed within 5 years except for basocellular
carcinoma or CIN
Encasement of CA, and/or SMA, and/or HA and/or G3-G4 degree
encasement of SMV and/or PV
Pregnancy
HIV positivity
Preoperative pathologic diagnosis of ductal adenocarcinoma
Mental disorders which might prevent the execution of a follow-up
ASA: American Society of Anesthesiologists; CA: celiac axis; SMA: superior mesenteric artery; HA: hepatic artery; SMV: superior mesenteric
vein; PV: portal vein; CIN: cervical intraepithelial neoplasia.
a few cases (fewer than 100) regarding the use of RFA Table 2. Clinical and imaging parameters evaluated for follow-up
in pancreatic cancer have been published. No authors assessment
Techniques used for evaluation
have conducted prospective studies and few studies have Parameter
[20]
reported long-term results. In this paper, we report the Progression of Abdominal ultrasonography every month
Serum determination of CA19-9 every month
results of a prospective study on the efficacy and safety of disease
Computed tomography at 6, 12 and 24 months
RFA in pancreatic head adenocarcinoma.
Performance
status
Eastern Cooperative Oncology Group performance
status every month
Methods
Quality of life
EORTC QLQ-C 30 questionnaire at 1, 3, 6, 12, 18
and 24 months
Only patients with a pancreatic head neoplasm,
potentially non-metastatic and unresectable because of
locally advanced disease, were recruited. This study was
undertaken to evaluate the safety and effectiveness of
RFA, improvement in the quality of life, and control of
post-operative pain in addition to the survival benefit
in patients who undergo RFA. Two interim analyses
were planned at six and twelve months to evaluate the
complication rate.
The inclusion and exclusion criteria for eligibility
to RFA are listed in Table 1. In brief, the inclusion and
exclusion criteria were based on past and present medical
history, clinical examination, HIV-ab determination,
and β-HCG serum levels to avoid pregnancy. Thoracoabdominal spiral multidetector computed tomography
was carried out to assess the presence of a tumor in the
pancreatic head, vascular encasement, and the absence of
distant metastases. The degree of vascular involvement
was assessed as reported by Calculli and colleagues.[21]
Contrast-enhanced ultrasonography was carried out
to exclude the presence of liver metastases. Endoscopic
ultrasonography, magnetic resonance and diagnostic
laparoscopy were conducted only in those patients in
whom previous staging imaging did not exclude distant
metastases or resectable disease. Subsequently, an
ultrasonography-guided core biopsy was performed to
obtain a pre-operative pathologic diagnosis. Finally, a
Pain
Brief pain inventory at 1, 3, 6, 12, 18 and 24 months
restaging was also made at laparotomy.
The surgical technique was standardized as follows:
the first step was to mobilize the head of the pancreas;
RFA was subsequently performed, usually with 2 or
more passes of the probe at 90 ℃ for 5 minutes each.[22]
RFA was carried out using the Cool-tipTM ablation
system (RadionicsTM). And finally, a double surgical
bypass (hepaticojejunostomy "end to side" using a Roux
loop and gastrojejunostomy) was performed to prevent
the occurrence of biliary fistula and duodenal occlusion.
The postoperative mortality rate included all
deaths within 30 days after surgery. The postoperative
morbidity rate included all complications following
surgery until the day of discharge. A pancreatic fistula
was defined as a drain output of any measurable
volume of fluid on or after postoperative day 3 with an
amylase content greater than 3 times the serum amylase
activity. Three different grades (A, B, C) were defined
according to the clinical impact on the patient’s hospital
course.[23] The length of the postoperative period was
defined as the interval from the day of surgery to
discharge. Chemotherapy was eventually performed in
all patients with progression of the disease. The patients
were followed up every month (Table 2). In brief, the
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Hepatobiliary & Pancreatic Diseases International
progression of the disease was evaluated by abdominal
ultrasonography, serum determination of CA19-9
every month, computed tomography at 6, 12 and 24
months, the performance status using the Eastern
Cooperative Oncology Group (ECOG) Performance
Status every month,[24] and the quality of life using the
EORTC QLQ-C30 questionnaire[25] at 1, 3, 6, 12, 18, and
24 months; the pain was assessed using the brief pain
inventory[26] at 1, 3, 6, 12, 18, and 24 months.
Statistical analysis
The mean, median, range, and frequency of the data
of the patients were described statistically.
Results
From October 2007 to April 2008, 7 patients were
enrolled in this study (Table 3). Their mean age was
66.1 years (range 47-80 years); 3 patients were male and
4
were female. Pre-operative staging revealed that only
Sample size
4
patients
were eligible for the RFA procedure (Table 4),
According to the data reported,[27] the expected 2 were excluded because of the presence of a metastatic
survival at 24 months was 35%. To differentiate this disease, and 1 was considered to have a resectable
survival from the 3% value in an internal reference tumor. Hence RFA was carried out in 3 patients because
database named NeoPan[28] with a control-to-case ratio
a total pancreatectomy performed in one patient for a
of 3:1, at a significance level of 0.05, and a power of 0.80,
resectable
tumor at laparotomy.
the estimated size of sample was 16 patients.[29]
The mean size of the lesion undergoing RFA was
46.7 mm. In all patients the neoplastic lesions were
Ethical approval
completely ablated. Finally, biliary bypass and gastroThe study was carried out according to the principles jejunostomy were performed in all patients. No
of the Helsinki Declaration for human studies. It was major intra-operative complications were registered,
approved on 17 July 2007 (code number 69/2007/O/ but extrasystolic arrhythmia was observed during
Sper) by the Ethics Committee of Sant Orsola-Malpighi radiofrequency ablation in one patient. In this series, the
Hospital and written informed consent was given by postoperative mortality rate was 0%, and the morbidity
each participant.
rate was 100%. All patients developed non-neoplastic
Table 3. Clinical, biochemical and radiological characteristics of patients enrolled in our study
Vascular encasement
CA19-9 Tumor
(U/ml) size (mm) SMV PV SMA HA
Case Sex Age ASA Symptoms
CA
Metastasis
Core biopsy
Eligible for
RFA
1
2
M
F
66
47
Ⅲ
Ⅲ
Pain, weight loss
Pain, weight loss
1846
3623
60
44
G3
G4
G3
G0
G2
G3
G0
G0
G0 No
G0 Pulmonary
metastases
ADC (G2)
-
Yes
No
3
4
5
6
7
M
M
F
F
F
62
68
80
65
71
Ⅱ
Ⅲ
Ⅲ
Ⅲ
Ⅲ
Pain, recent onset diabetes
Jaundice, vomiting
Pain, recent onset diabetes
Jaundice
Jaundice, pain, weight loss
536
6821
1333
56
<1
46
45
34
44
50
G3
G3
G3
G2
G2
G3
G2
G3
G0
G2
G0
G0
G0
G0
G1
G0
G0
G1
G0
G0
G0
G0
G0
G0
G0
ADC (G2)
ADC (G1)
ADC (G2)
-
Yes
Yes
Yes
No
No
No
No
No
No
Pulmonary
metastases
ASA: American Society of Anesthesiologists; SMV: superior mesenteric vein; PV: portal vein; SMA: superior mesenteric artery; HA: hepatic
artery; CA: celiac axis; ADC: adenocarcinoma.
Table 4. Outcome of patients eligible for RFA procedure
1
Yes
Surgical
intervention
Double bypass
3
4
5
Yes
No*
Yes
Double bypass
Total pancreatectomy
Double bypass
Case RFA
Intraoperative
complications
Extrasystoles during
RFA application
Postoperative
complication
Biliary fistula
GI bleeding Ascites
Postoperative
mortality
No
CA19-9#
(U/ml)
578
Hospital stay
Follow-up
(days)
43
DPF 4 months
No
No
Ascites
Ascites, vomiting
No
No
108
418
10
10
DPD 5 months
DPF 3 months
GI: gastrointestinal; DPF: died progression-free; DPD: died with progression of disease. *: RFA was not carried out because the patient was
found to have a resectable disease; #: the value refers to the first month of follow-up.
308 • Hepatobiliary Pancreat Dis Int，Vol 9，No 3 • June 15，2010 • www.hbpdint.com
Radiofrequency ablation for pancreatic cancer
self-limiting ascites, with normal fluid amylase after
8.6 days on average (range 7-9 days) after RFA. A major
complication occurred in a patient who developed a
biliary fistula 7 days after the procedure. The mean
hospital stay was 21 days (range 10-43 days).
In the three patients CA19-9 serum levels reduced.
Their preoperative values were higher than those at the
first month after surgical approach (from 1846, 536,
and 1333 to 578, 108, and 418 U/ml respectively; upper
reference value: 37 U/ml; Tables 3 and 4). Data on pain
control and quality of life assessment were not available
because of the poor clinical conditions of the patients.
The median ECOG score of performance status was 3, 4
and 5 respectively at 1, 3 and 5 months after RFA.
The three patients died at 3, 4 and 5 months after
treatment, two had no evidence of progression of
disease, and one developed liver metastasis and portal
thrombosis after 2 months. At the first interim analysis
the study was stopped.
Discussion
This is the first prospective study evaluating RFA in
clinical practice. In fact, a recent review of the literature[20]
indicated that there are few studies reporting the RFA
approach in human pancreatic cancer and that none
of them were carried out in a prospective manner. The
following critical points can be considered in RFA for
unresectable, non-metastatic pancreatic head cancer:
feasibility, safety, effectiveness, and long-term results.
Studies demonstrated that RFA is feasible in human
pancreatic cancer,[20] but thermal injury of the intrapancreatic common bile duct should be taken into
account as a complication of the ablation of lesions
localized in the pancreatic head.[22] Also, RFA may
cause inadvertent thermal necrosis of the portal vein,
duodenum, or common intrapancreatic bile duct.
These complications require surgical resection even
in the presence of an unresectable tumor. Similarly, a
late complication of RFA is duodenal occlusion as a
result of fibrosis after ablation of the pancreatic tissue.
Thus, ablation of pancreatic lesions, particularly in the
pancreatic head, always require a laparotomy and a
double surgical bypass.[19, 30]
In our study, patients with unresectable and nonmetastatic disease who were confirmed at laparotomy
underwent RFA. One patient was upstaged because of
the objective limits of imaging techniques.[31] Thus, it
is necessary to restage the tumor at laparotomy when
a RFA approach is planned. In all patients, complete
necrosis of the lesion was confirmed by intraoperative
and postoperative ultrasonography. At least two passes of
the probe were necessary to obtain a complete ablation of
the lesion (mean size 46.7 mm). In our patients optimal
thermal kinetic characteristics were produced by a target
temperature of 90 ℃ for 5 minutes. Thermal injury of the
portal vein or other major intra-operative complications
were not observed except extra-systoles in one patient
during the RFA procedure. The relationship between the
ablation procedure and this cardiac event has not been
conclusively clarified.
The safety of RFA for pancreatic cancer is still under
debate. The reported major post-operative complications
include septic shock, massive gastrointestinal bleeding,[32]
pancreatic fistulas[33] and severe acute pancreatitis.[34]
Elias et al[34] reported their experience with two patients
with diffuse pancreatic metastases of renal cancer.
Both patients developed severe acute pancreatitis after
RFA and died. The result was probably due to multiple
ablations, to the high temperature used (>90 ℃), and to
the lack of adequate instrumentation. In our experience,
however, we did not observe severe acute pancreatitis.
Tang et al[33] reported a frequency of 16.7% for
pancreatic fistulas and a postoperative mortality of
22.2% in 18 patients with unresectable pancreatic
tumors who underwent RFA. They concluded that the
standard use of cool-tip RFA is dangerous for patients
with pancreatic head carcinoma but safe for those with
tumors in the body and tail of the pancreas. We did not
find any pancreatic fistulas. In one patient, there was a
major biliary fistula caused by surgical procedure. The
data of our study were consistent with those of Koninger
and colleagues[35] who reported a complication rate
of 29% to 40% related to biliary surgical bypass in
unresectable peri-ampullary cancer.
Self-limiting ascites with normal fluid amylase
occurred within 7-9 days after the procedure in all patients.
Varshney et al[36] reported a similar complication. In our
patients postoperative CA19-9 serum levels decreased, as
previously reported[19, 30, 36] We hypothesized that this
marker may be used as an index of tumor volume after
RFA.[37] Our study assessed the effectiveness and longterm results of RFA for pancreatic cancer. Only two
non-randomized retrospective studies were conducted
using a cohort of comparison for long-term results.[27, 32]
One study evaluated 20 patients with unresectable and
metastatic carcinomas of the pancreas (stage Ⅳ). No
statistical differences were found in the prognosis of
these patients as compared with those of the same stage
who did not receive any treatment with RFA.[32] Our
experience does not answer this question because we
excluded patients with hepatic or pulmonary metastases.
Another study was carried out on 25 consecutive patients
who underwent palliative therapy for unresectable
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Hepatobiliary & Pancreatic Diseases International
pancreatic cancer. Thirteen patients received palliative
therapy alone and the other 12 received surgical palliative
therapy plus RFA. The overall mean survival rate in the
patients who were treated with palliative therapy was
13 months whereas those who also received RFA had a
mean survival of 33 months. The differences in survival
rates was statistically significant (P=0.0048). When the
difference in survival rates was calculated for patients of
the same stage, RFA provided survival benefits especially
for patients with stage Ⅲ pancreatic cancer (P=0.0032),
whereas stage Ⅳ patients had survival rates similar
to patients of the same stage who did not receive RFA
(P=0.1095).[27]
In our study, a survival rate at 3 months was 66.7%
(2/3), whereas at 6 months it was nil. In our NeoPan
series, the survival rates at 3 and 6 months was 91.7% and
73.3%, respectively. The small number of patients was not
suitable for a statistical analysis with historical series.
In our 3 patients data on pain control and quality
of life assessment were not available because of their
poor clinical conditions. The median ECOG score of
performance status was 3, 4 and 5 respectively at 1, 3 and
5 months after RFA. Because of the high complication rate,
the poor clinical condition of the patients, and the absence
of a survival benefit, we decided to terminate the study.
In our opinion, RFA is a feasible procedure but we
have observed a high rate of postoperative complications
but non-benefit of survival and quality of life. Finally, we
do not recommend the RFA procedure in patients with
locally advanced non-metastatic adenocarcinoma at least
in our experimental conditions.
Acknowledgment
The authors wish to thank Prof. R. Corinaldesi who cared for the
study patients.
Funding: None.
Ethical approval: The Ethics Committee of Sant' Orsola-Malpighi
Hospital approved the study on 17 July 2007 (code number 69/2007/
O/Sper).
Contributors: CR, PR and MF proposed the study. PR, CR and
RC wrote the first draft. AMML analyzed the data. All authors
contributed to the design and interpretation of the study and to
further drafts. PR is the guarantor.
Competing interest: No benefits in any form have been received
or will be received from a commercial party related directly or
indirectly to the subject of this article.
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140-146.
Received October 28, 2009
Accepted after revision April 6, 2010
Hepatobiliary Pancreat Dis Int，Vol 9，No 3 • June 15，2010 • www.hbpdint.com • 311