Results: an average of 13.5 days (range 10– 17

Results:

The number of patients in the current study was 6. Their median
age was 60 year (range 50-71). They were four males and two females. Their
tumor were 3 pancreatic cancer, two ampullary cancer and one from the duodenum.
Five of them had complete resection plus the application of IORT. One patient
was found to have unresectable tumor. Bypass operation was performed combined
with IORT.  Median operative time was 4.5
hours (range 4- 6 hours). The histopathological results were demonstrated in (Table.
3). The postoperative hospital stay had an average of 13.5 days (range 10–
17 days). All patient tolerated the procedure without in-hospital morbidity or
mortality. No patient had neoadjuvant chemotherapy. Only 4 patients had postoperative
chemotherapy. All patients had regular follow up. Follow up was done every 3
months for the first 2 years then every 6 months for the next 2 years then
annually. The follow up entails physical examination, complete laboratory tests
with tumor markers and CT scan.

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During the follow
up period, two patients died. The type of
cancer for both patients was pancreatic cancer.  They both had surgical resection combined with
IORT and they both had postoperative chemotherapy. The first patient who had
advanced disease died after 14 months from disease progression and liver
metastases. The other patient died after 17 months. This patient had recurrent
parathyroid cancer that was operated before. He died from lung metastases that proved
by biopsy to be metastases from the parathyroid cancer. This patient received
postoperative chemotherapy.

The remaining
4 patients are still surviving with overall free survival rate 66.6%. They come
regularly for follow up. They have no disease recurrence. The median follow up
period was 18 months (range 6-41).

Discussion:

IORT was applied since more than 4 decades. It was
discovered in Japan. IORT was applied in patients with resectable or partially resectable
tumors  (10). The idea is to allow the radiation beam to pass from
the radiation machine to the affected area with residual tumor tissues after incomplete
resection or the area of the tumor bed after the complete surgical removal of
the tumor. The radiation beam will be allowed to access the targeted area
directly in a focused high concentrated beam. This will guarantee the delivery
of a dose of radiation which is a relatively high to be directed to the target
areas which increases the chance of destroying the residual cells remaining
after tumor resection. The unaffected organs and tissues can be shielded or
taken away in order to minimize the risk of radiation complications on them (11). A lot of studies
evaluated the role of the application of IORT on locally advanced diseases or
residual diseases after tumor resections. They concluded that it is very effective
on the residual tumor and moreover it increases the period taken for the tumor to
recur (12, 13). These
results also can applied also for patients with resectable pancreatic and
periampullary adenocarcinoma. In cases of advanced tumors which are not amenable
for complete resection, IORT can destroy the tumor in its place which decreases
its local complications. It also can decrease the local infiltration of the tumor
to the nerve plexuses thus decreases tumor pain (14).

The studies that was carried out to assess the effect of adding
IORT in the management of patients with pancreatic or periampullary cancer are retrospective
(15-18). Also many studies
assessed the results in patients who have complete resection combined with IORT
and who had complete resection without IORT application (4).  They concluded
that the addition of IORT reduces the incidence of the recurrence of tumors (4). Zerbi et al. (15)  recorded the effect
of the application of IORT on patients after surgical resection of the tumors and
studied the results in patients who had surgical resection of the tumor without
the addition of IORT. This study showed that IORT application will not affect
the postoperative course of the patient regarding morbidity and operative
related mortality. With regard the recurrence of the resected tumor they
concluded that it is significantly higher in patients who had their surgeries
without the addition of IORT. Another study was applied on 127 patients who had surgical resection plus IORT and 76
patients who had surgical resection alone. They concluded that the application
of IORT did not affect both the post-operative morbidity and operative related
mortality. They also found that the application of IORT delayed the local
recurrence significantly in the first group especially in patients with early
stage tumors (16). Recent studies
came to the same conclusion (17, 18).  After the review of the histopathology of our
patients retrospectively who had surgical resection without the addition of
IORT, we found some patients who had affected lymph nodes.  Also after the reviewing the related literature,
we added IORT application as part of the protocol applied in the treatment of
pancreatic and periampullary cancers. Our initial results showed that IORT application
added much benefit in the management of these tumors.

Conclusion:

Adding IORT as a part of the management of advanced
tumors is a very safe and feasible procedure. The patient can withstand the
procedure well. It did not affect the postoperative course of the patient regarding
morbidity and operative related mortality. Our preliminary results are favorable.
In order to give a final conclusion, the study needs to be applied on larger
number of patients with long period of follow up.