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. Author manuscript; available in PMC: 2023 Aug 17.
Published in final edited form as: Gastrointest Endosc. 2021 Feb 26;94(1):179–186. doi: 10.1016/j.gie.2021.02.027

Table 1.

Study participant selection criteria.

Inclusion criteria Exclusion criteria
Histological evidence of locally advanced pancreatic cancer or small volume metastasis not amenable to systemic chemotherapy and surgical resection, if the patient is unfit or refuses surgical resection Evidence of metastasis other than to lung or liver.
If metastasis in the lung or liver, lesions must be <5 cm in diameter
Age >18 years Age <18 years, pregnancy, breast feeding, or porphyria
Measurable tumor as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria Locally advanced disease with more than 50% of the circumference of the duodenum involved or involvement of a major artery
ECOG performance stage 0–2 ECOG performance status 3–4
Estimated life expectancy of at least 12 weeks Prior treatment with curative intent within the past 12 weeks before entry
Capable of giving informed consent Any psychiatric condition that makes informed consent impossible
Adequate biliary drainage with total bilirubin <2.5 times the upper limit of normal Documented hemorrhagic diathesis or coagulopathy, need for therapeutic anticoagulation, history of additional past or current malignancy that would interfere with treatment response evaluation
Women of childbearing age require a negative pregnancy test before study and must remain on contraception for the duration of the study Evidence of uncontrolled systemic disease or laboratory finding that would in the investigator’s opinion undesirable for the patient to participate in the trial