Malignant neoplasm of pancreas. Pancreas, unspecified
Conditions
Interventions
Intervention 1: Intervention group: Gemcitabin injection into the advanced and inoperable pancreatic cancer
dosage, gemcitabin in normal saline at a concentration of 40 mg per ml is prepared and injected. FNA needle 22 is injected into the tumor center. Finally, the drug was injected between 2 to 4 ml. Inte
Treatment - Drugs
Intervention group: Gemcitabin injection into the advanced and inoperable pancreatic cancer
Control group, those without gemcitabin injection into the tumor and are treated only by systemic chemotherapy.
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: advanced pancreatic cancer that is non-operative and is proven by three phasic CT scan and Endosonography and proving positive cytology for pancreatic Adenocarcinoma. Exclusion criteria: first operative pancreatic cancer; second asprin usage; administration of other NSAIDs or anticoagolant in the last week of endosonography or FNA is also important.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Regression of disease. Timepoint: 1) prior to injection of intratumoral Gemcitabin 2) 2 weeks after the first injection 3) 12 weeks after the second injection (ie 24 weeks after first injection). Method of measurement: CT scan and endosonography.;Time to disease progression. Timepoint: 1) prior to injection of intratumoral Gemcitabin 2) 2 weeks after the first injection 3) 12 weeks after the second injection (ie 24 weeks after first injection). Method of measurement: CT scan and endosonography.;Side effects. Timepoint: 1) The first day after injection 2) the second week after the first injection 3) 12 weeks after the first injection (day of the second injection) 4) 48 weeks after first injection. Method of measurement: History and physical examination and lab data as needed and Based on a questionnaire that was attached to the proposal. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life. Timepoint: 1) baseline (before first injection) 2) 4 weeks after the second injection. Method of measurement: Scoring based on the SF 36 questionnaire.;Survival. Timepoint: 6 and 12 months after the second injection. Method of measurement: Patients alive long after entering the study, based on history and physical examination. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNeda Rabiei
Tehran University of Medical Sciences
Outcome results
None listed