ISSN: 2320-5407 Int. J. Adv. Res.

12(05), 647-651

Journal Homepage: - www.journalijar.com

Article DOI: 10.21474/IJAR01/18766

DOI URL: http://dx.doi.org/10.21474/IJAR01/18766

RESEARCH ARTICLE
IMPROVEMENT IN QUALITY OF LIFE FOLLOWING PERCUTANEOUS TRANSHEPATIC BILIARY
DRAINAGE FOR MALIGNANT OBSTRUCTIVE JAUNDICE: AN INSTITUTION-BASED
OBSERVATIONAL STUDY

Dr. Arkaprovo Roy1, Dr. Suchismita Chakraborty2 and Dr. Ayusmati Thakur3
1. Associate Professor, Department of Surgery, Medical College Kolkata.
2. Senior Resident, Department of Surgical Oncology, Banaras Hindu University.
3. Consultant Gastroenterologist, DNB(General Medicine), MRCP UK.
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Manuscript Info Abstract
……………………. ………………………………………………………………
Manuscript History Purpose: Long-term prognosis of patients with obstructive jaundice
Received: 20 March 2024 due to malignant biliary disease is very dismal. These patients are
Final Accepted: 27 April 2024 treated mainly for palliation of symptomatic jaundice and related
Published: May 2024 complications. To alleviate symptomatic jaundice, three modalities of
treatment are generally employed – bilio-enteric bypass, Percutaneous
Key words:-
Quality of Life, PTBD, Obstructive Transhepatic Biliary Drainage (PTBD) and Endoscopic Retrograde
Jaundice, Carcinoma Gall Bladder Cholangiopancreatography guided stenting. However, minimal data is
available comparing the pre-procedure and post-procedure Quality of
Life (QOL) of these patients.
Aims of the Study: To study the pre-procedure & post-procedure QOL
of patients undergoing PTBD.
Methodology: We studied patients who underwent PTBD in between
January 2017 and June 2021, attending our tertiary-care hospital with
malignant obstructive jaundice, with high-up biliary obstruction. An
observational study was conducted to compare the QOL before and
after procedure using the EORTC-QLQ-30 Symptom Scale Score.
Results:The majority (80%) had the diagnosis of carcinoma
gallbladder. Maximum number of patients (75%) presented with a pre-
procedure bilirubin value of more than 15 mg/dl. These patients
showed significant bilirubin decrement by day 7. Follow-up at 1 month
and 3 months following PTBD demonstrated significant improvement
in global health status, physical status, emotional, cognitive and social
QOL score. Some deterioration in the QOL score was noted at 6
months follow-up, which might be related to recurrence or stent
blockade.
Conclusion: Overall improvement in post-procedure QOL was
observed during follow-up analysis of the subjects. The increase in
financial burden could be attributed to the maintenance of drainage
catheter (wound management bags, treatment of infections) and cost of
frequent hospital visits after the procedure.

Copy Right, IJAR, 2024,. All rights reserved.

……………………………………………………………………………………………………....

Corresponding Author:- Dr. Arkaprovo Roy

Address:- Associate Professor, Department of Surgery, Medical College Kolkata. 647
ISSN: 2320-5407 Int. J. Adv. Res. 12(05), 647-651

Introduction:-
Quality of life (QOL) is a highly subjective measure of happiness, related to a number of variables that differ according
to personal preferences. World Health Organization (WHO) defines quality of life as an individual‟s perception of their
position in life in the context of the culture and value systems in which they live and in relation to their goals,
expectations, standards and concerns. It is a broad concept that is affected in a complex way by a person‟s physical
health, psychological state, personal beliefs and social relationships. [1]Over the last decade, the focus of health care for
patients with advanced malignancy has shifted from curative intent to hospice, which is basically a type of healthcare
that focuses on the palliation of a terminally ill patient‟s distressing symptoms and attending to their emotional and
spiritual needs.

Malignant obstructive Jaundice can develop due to direct involvement of CBD by carcinoma gall bladder,
cholangiocarcinoma and pancreatic adenocarcinoma as well as due to external compression by metastatic lymph nodes
at porta. However owing to the non-specific symptoms and lack of any widely accepted screening protocol, these
malignancies tend to be diagnosed at an advanced, inoperable state and the patient is rendered to live rest of his life with
distressing symptoms like jaundice, pruritus, pain abdomen, anorexia and malnutrition. Various palliative procedures
remain the only treatment option for improvement of the Quality Of Life (QOL) includingalleviation of cholangitis and
pruritus. Reduction in serum bilirubin level below 3 mg/dl is also mandated before initiating chemotherapy or
intrabiliary brachytherapy. Various methods of biliary drainage include surgical bypass and minimally invasive
procedures like Percutaneous Transhepatic Biliary Drainage (PTBD) and Endoscopic Retrograde
Cholangiopancreatography (ERCP).

For the patients with symptomatic malignant obstructive jaundice those are deemed unfit for surgery, urgent treatment is
required to improve hepatic function, in order to facilitate the addition of subsequent chemotherapeutic regimen. In this
context van researchers have evaluated the role Percutaneous Transhepatic Biliary Drainage (PTBD) and stenting as
emerging alternative treatment of malignant biliary obstruction (MBO). It exhibited good clinical efficacy and fewer
complications and lead to limited patient suffering as compared to surgical bypass. Among the study subjects, reported
technical success in >90% and clinical success in >75%, with procedure related mortality <2% [2]. Palliative value of
PTBD was shown in another prospective study. [3]. It was found to reduce the severity of pruritus significantly. However,
mixed results have been obtained with regards to the effect of PTBD on the quality of life and majority of such studies
performed were based on some arbitrary quality of life scores.

Common complications following the procedure of PTBD include drain dislodgement and the need for re-intervention,
pain and biliary leakage around the puncture site, haemorrhage, perforation,haemobilia, cholangitis and stent
migration. Therefore, it is really important to weigh the potential benefits and risks of this procedure in patients with
MBO [4,5,6]. Factors able to predict long and short-term survival after PTBD are scarcely reported in the medical
literature and have not yet been well established. In our study, we attempt to document the short and long-term
improvements in the QOL of patients with MBO following PTBD.

Methodology:-
It is an observational retrospective-prospective study done on 155 patients with malignant obstructive jaundice, who
attended the Interventional Radiology department of our institution,betweenJanuary 2017 and June
2021,aftertakinginformedconsentfromthe patients. The study was approved by the institutional ethics committee.We
included unresectable cases of carcinoma gall bladder and cholangiocarcinomawith obstruction at the level of upper
CBD, causing jaundice (serum bilirubin more than 10mg/dl), cholangitis and/or pruritus.They weresubjected to PTBD
with external drainage and/or internal stenting.Patients with resectabletumours, poor performance status (Karnofsky
index less than 60) or those with severe sepsis and hepatocellular failure were excluded. Figure 1 depicts the proforma
for pre-procedural data collection from the patients.

The efficacy of biliary drainage was determined in terms of daily reduction in serum bilirubin value till day 7 and
bilirubin values at 1 month, 3 months and 6 months follow-up visits. We also took into consideration in-hospital
mortality, 30-day mortality, post-procedure survival, duration of stent patency (i.e. requirement of repeat PTBD due to
stent blockade) and any other post-procedural complication including cholangitis. Improvement in post-procedural
QOLwas assessed using the European Organization for Research and Treatment of Cancer Quality of Life
Questionnaire 30 (EORTC-QLQ-30) (Figure 2). This questionnaire incorporated 30 questions altogether, to assess five
functional scales – physical (Q1-5), role (Q6-7), cognitive (Q20, 25), emotional (Q21-24), social (Q26-27); three

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symptom scales – fatigue (Q10, 12, 18), pain (Q9, 19), nausea-vomiting (Q14, 15) and a global health and QOL scale
(29, 30) with financial impact score (Q28). [7,8]Scores were calculated before the procedure and at the 7 th post-
procedural day, 1-month, 3-month and 6-month visits. They were compared using a series of paired t-tests. All of the
statistical analyses were performed using Microsoft Excel 2016 and SPSS software version 6.0.

Results:-
Total of 155 unresectable cases of malignant obstructive jaundice were selected during the study
periodandpatientswerepredominantly fromWestBengalandneighbouring states.

After thorough history taking, physical examination and investigations, 124 (80%) of them were found to have a
carcinoma gall bladder, whereas the remaining 31 (20%)were diagnosed with hilarcholangiocarcinoma. We observed
that among those diagnosed with cholangiocarcinoma, 15 (48%) patients were male, whereas 16 (52%) patients were
female.Therefore,the female:maleratiocameuptobe1.06:1. On the other hand, among those with carcinoma gall bladder,
46 (37%) were male and 78 (62.9%) were female. The female:male ratio in gall bladder carcinoma was calculated as
1.69:1. These ratios, however, do not correlate with the female:male ratio found in studiesconducted worldwide, which
is close to 1:2 and 2-2.25:1 respectively.[9,10] Itwas also foundthat45(29%)outof155patients werebetweentheage
groupof41-50years, followed by 42(27%) patients in 51-60 years of age group. The age incidence is much lower than
that described in westernliteratures (SEER Cancer Statistics Review, 1975-2017).[11]
Thereasonbehindthislowerageincidenceofbothcarcinoma gall bladder and
cholangiocarcinomacouldbeageneticpredispositioninthesubcontinentalpopulation.

41 (26.4%)patientswere identified asvegetarian.None ofthemwere obese(i.e.BMI>30). Out of 155 patients, 35 (22.8%)

were smokers, whereas 13 (8.57%) gave history of regular alcohol intake. 13
patients(8.57%)werebothsmokersaswellasalcoholics.Noneofthefemalepatientsweresmokeroralcoholic. We
sawthat40(25.7%)patientshad previous history of gall stone disease and/or choledocholithiasis.

Conjugated hyperbilirubinemia of more than 15mg/dl was observed among 117 (75%) patients and remaining 38 (25%)
patients had less than 15mg/dl bilirubin value. In the latter group of patients the indication for performing PTBD was
palliative chemotherapy, intractable pruritus, deranged hepatic function or recurrent cholangitis. Mean value of serum
bilirubin was calculated immediately before the procedure, as well as on day7, 1month, 3 months and 6 months follow
up visits. It was observed that mean pre-procedure serum bilirubin value was 19.2mg/dl with a standard deviation of
6.05. Post-procedure bilirubin values at 7th day, 1 month, 3 months and 6 months (as mean ± standard deviation) are,
respectively 10.89 SD 6.46, 4.98 SD 1.01, 2.6 SD 0.81 and 1.5 SD 0.77. Serial paired t-tests were applied to compare the
decrease in bilirubin value in each follow-up visit concerning pre-procedure value. All the p values were well below
0.00001, which signifies the efficacy of PTBD in lowering serum bilirubin value. Table 1 depicts the mean and standard
deviation of serum bilirubin value in various time frames.

All the patients were given the EORTC-QLQ-C30 questionnaire to be filled up before the procedure and in each follow-
up visit. It was observed that the mean functional score of patients in the pre-procedure period and post-procedure day7,
1 month, 3 months and 6 monthsfollow-up visits were 52.7 SD 6.1, 34.08 SD 9.82, 20.9 SD 8.13, 9.1 SD 4.13 and 13.5
SD 5.13 respectively. On the other hand, mean symptom scale scores were 25.6 SD 2.1, 12.8 SD6.9, 9.2 SD 3.99, 7.45
SD 3.89 and 8.89 SD 2.12 respectively. We obtained respective financial scores in different periods as 3.7 SD 0.23, 3.2
SD 0.61, 1.9 SD 0.9, 1.5 SD 0.34 and 0.78 SD 0.11. The mean of pre-procedure quality of life and global health score
was 3.24 SD 2.39. It improved on post-procedure day 7 to a score of 8.11 SD 5.01, 12.09 SD 1.56 at 1 month, 12.99 SD
1.9 at 3 months and 11.99 SD 1.78at 6 months. Again, we applied serial paired t-tests onto the data set comparing post-
procedure data sets on day 7, 1 month, 3 months and 6 months follow up to pre-procedure values and in every instance,
the p-value was statistically significant (less than 0.001).Figure 3a and 3b show a composite bar diagram comparing
mean values of the several components of the EORTC-QLQ-C30 questionnaire as measured at different follow-up visits.

We have included the complications following PTBD in our collected data. 28 (18.06%) out of 155 patients had suffered
from some complication after the procedure and required repeat hospital admission. Among these 28 patients, 13 (46%)
had the problem of stent block, 10 (36%) suffered from cholangitis, 4 (14%) were diagnosed to have peri-drain wound
infection and 1 (4%) patient presented with biloma.

Wedocumentedsurvivalratefor eachpatientafterthe procedureand regularlyfollowed themup. It was observed that 5 (3%)

out of 155 patients died during the initial hospital admission.14 (9.03%) patients survived for less than 30 days

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following PTBD, another 19(12.2%)remained alive upto 3months. 91 (58.7%) patients survived upto 180 days and 25
(16.1%) for more than 6 months. 6 (3.8%) patients were still living at the end of the study time. We also found that 30-
day mortality rate was 64.7% among patients requiring repeat hospital admission, whereas only 2.4% among those
without any history of repeat hospital admission.

Discussion:-
According to a paired t-test performed between QLQ scores in the pre-procedure and post-procedure follow-up visits,
significant improvement was found in the mean score of the study population at Day 7, 1 month and 3 months follow-up
visits (p = 0.001). Scores at 6 months follow-up visit deteriorated, however. At the same time, it was observed that the
mean serum bilirubin level of the study population was decreasing significantly till the 3-month follow-up visit, only to
rise again at the 6-month visit. These can be attributed to the progression of primary tumours and/or the development of
metastases leading to stent blockade.A randomised controlled trial conducted in India on carcinoma gall bladder patients
with obstructive jaundice, in 2008, concluded that PTBD has higher chances of successful drainage (p = <.001),
equivalent 30-day mortality (p = .61) and a similar rate of stent occlusion (p = .63) as compared to endoscopic stenting
(ES).Emotional functioning score as per the EORTC QLQ-C30 questionnaire was better in the ES group and cognitive
score better in the PTBD group at 1 month. Global QOL score was better in the PTBD group at 3 months.The symptom
scale score was improved in both arms, with considerable improvement of fatigue in the PTBD group.[12]A systematic
review and meta-analysis conducted in 2017 compared the efficacy and complication rate of PTBD and endoscopic
biliary drainage (EBD). Incidence of cholangitis and pancreatitis were lower in patients undergoing PTBD, whereas rate
of bleeding and tube dislocation were lower in EBD. [13]A randomised controlled trial was undertaken to compare the
quality of life of patients following „right‟ and „left‟ access PTBD using the QLQBIL-21 questionnaire. Those having
undergone PTBD through RHD access had higher intercostal pain, respiratory difficulties, greater amount of tiredness,
anxiety and more difficulty in drain bag management. Therefore, patients with PTBD via LHD had a better post-
procedure quality of life. [14]There were a few negative reports regarding quality of life improvement following PTBD
procedure. A prospective study done by in India in the year 2021 showed at least one complication in 68% patients and
at least two complications in 30% patients. Significant decrease was observed in post-procedure quality of life at 4-6
weeks, when assessed by SF-36 questionnaire. [15]

There has hardly been any observational study, conducted on quality of life assessment of patients with malignant
obstructive jaundice undergoing PTBD based on the EORTC QLQ C-3O questionnaire. Hence, our study can be
considered as one of the pioneers in this aspect. Results of this study reflected similar data as that of the other previously
mentioned studies. In future, similar other studies could be conducted on a multi-centre basis and using a larger sample
size.

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