Study design: in this single centre prospective randomized study, 77 patients underwent PTBD for malignant obstructive jaundice from February 2017 to April 2018.
As inclusion criteria to participate to the study we set: no age and gender limitation,
imaging studies confirming the presence of distal malignant bile duct obstruction,
hilum stricture,
patients affected from surgically unresectable neoplasm,
failed endoscopic treatment,
US-guided puncture of biliary tree considered indifferently feasible from the right or left side.
We excluded patients who refused to participate to the study,
patients with massive ascites,
patients with significant and uncorrectable coagulation abnormalities (aPTT,
INR,
platelet were evaluated),
and patients with abnormalities in respiratory function (we evaluated the origin of pain after procedure and decided to exclude them in order to rule out bias).
The patients considered eligible (n=63),
underwent PTBD via the “right” or “left” approach on the basis of a predetermined random string,
and were divided into two subgroups ( subgroup A - right access; subgroup B - left access).
At the end of the procedure,
the EORTC QLQ-BIL21 questionnaire was administered to all patients every day of the week.
In order to typify the kind of pain,
we asked the patient about the site of pain and breathing difficulties at day first and seventh.
Sedation and analgesia protocol used was the same for all patients.
It included a combination of midazolam and fentanyl to achieve conscious sedation state [14].
CIRSE checking-list was used by nurse operator in order to verify every aspect of the pre-procedural setting [15].
Depending on the random predetermined approach,
"right" (below the tenth rib in mid-axillary line with 10° forward and cranial angulation of needle tip) or "left" (subxiphoid),
the biliary ductal puncture was carried out through US guidance.
Technical success was defined as successful drain insertion across the malignant stricture.
Therapeutic success was considered to have been achieved when a total bilirubin level decrease of 30% was attained.
Any complication was evaluated and managed [16-17].
At the end of the procedure,
the patients were asked to answer the questionnaire.
Quality of life measure and statistics: The quality of life was evaluated with the EORTC QLQ-BIL21 questionnaire.
It comprises 21 questions assessing disease symptoms divided into eight items scale.
In particular,
it is formed by five multi-item scales (“Eating scale”,
“Jaundice scale”,
“Tiredness scale”,
“Pain scale” and “Anxiety scale”) and three single items about treatment side effects (“Treat scale”),
drainage tubes/bags (“Drain scale”) and about losing weight (“Weight loss scale").
Responses to the EORTC QLQ-BIL21 questionnaires were elaborated using EORTC guidelines [18].
Two further questions about the site of pain and respiratory difficulties investigate the quality of life of patients independently,
at day first and seventh (Tab 2).
The null hypothesis was that there were no differences in QoL between the two subgroups.
The null hypothesis was refuted at a level of significance of p ≤ 0.05.
We analysed EORTC-QLQBIL21 questionnaire answers using descriptive statistics with means (parametric data) and standard deviations (SD),
and numbers and percentages as appropriate.
Continuous variables were summarized by mean ± SD and compared using a two-tailed t-test.
P-values below 0.05 were considered statistically significant and p-values below 0.01 highly statistically significant.