Results: recurrence. The median follow up period was 18

Results:

The median age of patients was 60 year (range 50-71).
They were four males and two females. The type of cancer was 3 pancreatic
cancer, two ampullary cancer and one duodenal cancer. Five patients had
complete surgical resection combined with IORT. One patient was found to have
unresectable tumor. Bypass operation in the form of choledochojejunostomy and gastrojejunostomy
was done combined with IORT. The median operative time was 4.5 hours (range 4-
6 hours). The histopathological results were demonstrated in (Table. 3).
The average postoperative hospital stay was 13.5 days (range 10– 17 days). All
patient tolerated the procedure without in-hospital morbidity or mortality. No
patient received neoadjuvant chemotherapy. Only 4 patients received
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 imaging by CT scan.

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During the follow
up period of the current study, 2 patients died. Both patients were diagnosed to have pancreatic cancer.  Their management was surgical resection
combined with IORT and they both received postoperative chemotherapy. The first
patient who had unresectable tumor died after 14 months from disease progression
and liver metastases. The second patient died after 17 months. This patient had
recurrent parathyroid cancer that was operated before. He developed lung
metastases which was 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 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. Since then, IORT was applied in patients with non-metastasizing,
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 tumor residual after incomplete
resection or tumor bed after complete tumor resection. This beam will have access
to the targeted area directly in a focused concentrated beam. This will
guarantee the administration of a big dose of radiation to the affected areas
which increases the chance of destroying the tumor cells remaining after
surgical resection. The unaffected organs and tissues can be shielded or taken
away in order to decrease the risk of radiation complications on these organs (11). Many studies
evaluated the effect of the application IORT on the patients with locally
advanced diseases or who have residual diseases concluded that it is of great effect
on the residual tumor and also increases the period taken for tumor recurrence (12, 13). These
results also can applied also for patients with resectable pancreatic and
periampullary adenocarcinoma. In cases of locally advanced tumors which are
beyond complete surgical resection, IORT still has the advantages of destroying
the disease locally which  decreases its
local complications and decreasing the tumor pain resulting from the
infiltration of the neural plexus (14).

The studies that recorded the effect of IORT application for
the patients who have pancreatic or periampullary cancer and who had complete surgical
resection are mainly retrospective (15-18). Also many studies
have recorded the results in patients who have complete resection combined with
IORT and who had complete resection without IORT application (4).  They concluded
that the application of IORT reduces the incidence of disease recurrence. (4). Zerbi et al. (15)  studied the
effect of the application of IORT on patients after complete tumor resection and
compared them with patients who had complete tumor resection without IORT application
and they found that IORT application will not add for postoperative patient’s
morbidity and mortality. Also, they found that the incidence of tumor recurrence
was only 26% in the group of patients who received the IORT compared with 56% tumor
recurrence in the group who had complete resection without IORT application. Another
study was conducted on 2 groups of patients. The first included 127 patients
who had complete resection of the tumor with the application of IORT and the
second included 76 patients who had complete tumor resection without IORT
application. The results showed that the application of IORT did not affect
both the post-operative complications and operative related mortality. They also
found that the application of IORT delayed the local recurrence significantly in
the first group especially in patients who have their tumor in its early stages
(16). More recent
studies came in accordance with these result (17, 18).  After the review of the histopathology of our
patients with pancreatic and periampullary cancer and the affection of the localized
tissues and lymph nodes and also after the review of the related literature, we
started to apply IORT as part of our protocol in the treatment of pancreatic
and periampullary cancers. Our initial results from our center prove the benefit
of the application of IORT as a part of the management of theses tumors.

Conclusion:

Application of IORT is a very safe and feasible
procedure. The patient can tolerate it well. It did not affect the
postoperative course regarding postoperative complications and operative
related mortalities. Our preliminary results are favorable. In order to have a
rigid recommendation for the application of IORT, the study needs larger number
of patients with long period of follow up.