| Methods |
Randomised clinical trial |
| Participants |
Country: Greece
Number randomised: 56
Post‐randomisation dropouts: not stated
Revised sample size: 56
Average age: 66 years
Females: not stated
Inclusion criteria
1. Carcinoma of the head of the pancreas with regional vascular involvement of the superior mesenteric or the portal vein
2. Tumour at least 5 cm in diameter
3. Extension of the tumour on to the neck of the pancreas
Exclusion criteria
1. Underwent a standard Whipple's procedure
2. Had distant metastases
3. Vascular invasion could not be documented during dissection |
| Interventions |
Participants were randomly assigned to two groups
Group 1: surgical resection (n = 27)
Further details: Patients underwent en bloc splenopancreatectomy which involved total pancreatectomy, splenectomy, and end‐to‐end portal venous mesenteric repair
Group 2: palliative treatment (n = 29)
Further details: Palliative bypass surgery with chemoimmunoradiotherapy. Chemotherapy included a 5‐day course which included gemcitabine, carboplatin, mitoxantrone hydrochloride, mitomycin, fluorouracil and folinic acid. Immunotherapy involved interleukin‐2. Adjuvant chemoimmunotherapy was carried out every 2 months for the first year, every 4 months for the 2nd and 3rd years and every 6 months for the 4th and 5th years |
| Outcomes |
The outcome reported was survival |
| Notes |
Attempts were made to contact the authors in January 2013. The author replied about the experience of the surgeons |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Comment: This information was not available |
| Allocation concealment (selection bias) |
Low risk |
Quote: "Patients were randomly divided into two groups, A and B, by the anaesthetist, according to the chosen sealed envelope in the operating theatre" |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Comment: It is impossible to blind the healthcare providers |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Comment: This information was not available |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Comment: This information was not available |
| Selective reporting (reporting bias) |
Low risk |
Comment: Survival was reported |
| Vested interest bias |
Unclear risk |
Comment: This information was not available |
| Expertise bias |
Low risk |
Comment: The pancreatic surgery was performed by experienced surgeons (implied in author's replies) |
