Critical Apprisal of A Prospective Study

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VAN KARLO L.

LABASAN WVSU COLLEGE OF MEDICINE

CLINICAL CLERKSHIP A.Y. 2023-2024


DEPARTMENT OF PEDIATRICS – WARD
(FEBRUARY 1-29, 2024)

JOURNAL CRITICAL APPRAISAL

CLINICAL CASE

This is a case of M.M.F., a 5 year old, female child, who was admitted to the emergency room
due to abdominal pain and vomiting last 2/18/24.
Five days prior to consult (PTC), patient experienced umbilical pain, 7/10 squeezing pain,
radiating to the epigastric area associated with 2 episodes of vomiting of previously eaten contents,
measuring approximately 1 cup each, non-mucoid and non-bloody in character. Patient was given
“balsamo” which provided relief. No symptoms or recurrence was noted since then, but 4 hours PTC,
patient’s abdominal pain recurred with 2 episodes of vomiting of previously eaten food, still
measuring approximately 1 cup each. Persistence of pain prompted admission to the ER. Patient’s last
bowel movement was 2/17/24. There were no associated (-) fever, (-) headache, and (-) loss of
appetite. Patient had (+) nausea, which resulted to (+) vomiting of previously eaten food. There was
(+) difficulty of breathing but without any associated (-) back pain, and (-) chest pain. There was no (-)
urinary changes and (-) edema. Patient had non-distended abdomen but firm to touch. Patient also
has distinct wounds with yellow crusts on palms and feet.
As for the past medical history, the patient had history of hospitalization where she passed out
worms rectally and orally at 1 year of age. Mother was unsure whether her daughter received anti-
helminthic drugs. Patient had complete immunization history as claimed. Patient had no food and drug
allergies and no surgical history. As for the past medical history, the patient lives in a 2-storey house
with 4 bedrooms. She resides with 16 other family members. She lives in a congested neighbourhood
near the coast. According to the mother and elder sister, the patient was observed often to eat
without hand washing. The environment where the patient resides suggests increased likelihood of
getting infected with microbes and parasites.
Patient was seen and examined at the ER. Serum sodium and potassium were low. Urinalysis
was done but showed unremarkable results. Fecalysis was also requested. The gastrointestinal losses
during multiple episodes of vomiting were replaced vol/vol with PNSS. Patient was placed on NPO and
CBG monitoring q8h while on NPO. Omeprazole 20mg IVTT, then OD pre-breakfast was given for
abdominal pain, Ondansetron 2mg PRN for vomiting (0.15mkdose), and Clindamycin 120mg IVTT q6H
(32mkday).
Initially, the patient was managed as a case of ACID PEPTIC ULCER DISEASE WITH MODERATE
DEHYDRATION ORS FAILURE; T/C STAPHYLOCOCCAL INFECTION, but was later revised after whole
abdominal UTZ revealed elongated tubular structure within the intrahepatic and common bile duct
and biliary ascariasis was considered. Fecalysis, however, showed neither ova nor parasites. Gram
stain of the hand and foot lesions showed Streptococcus pyogenes and thus was treated with
Clindamycin.
Endoscopic retrograde cholangiopancreatography (ERCP) was done. Specifically, papillotomy
and worm extraction were done while under anesthesia. Mebendazole 50mg/ml syrup 10ml single
dose was given 1 day post-ERCP. The patient no longer complained of abdominal pain while at the
pediatric ward post-ERCP. Final diagnosis was BILIARY ASCARIASIS; CULTURE-PROVEN IMPETIGO (S.
PYOGENES); HEALTHCARE ASSOCIATED PNEUMONIA; MODERATE DEHYDRATION- RESOLVED S/P ERCP
(2/21/24). The patient

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ANATOMY OF CLINICAL QUESTION

HOW DOES THE TREATMENT OUTCOME FOR BILIARY ASCARIASIS DIFFER AMONG PATIENTS
RECEIVING MEDICAL THERAPY AND MEDICAL THERAPY PLUS ERCP?

JOURNAL SEARCH

In the search for the journal articles relevant to the clinical questions, keywords “biliary
ascariasis”, “ERCP”, and “medical therapy” were typed in the ScienceDirect
https://www.sciencedirect.com/browse/journals-and-books) search bar. Originally, there were 25
articles present on the search result, but only 4 were within the past five years of publication. The first
study on the menu entitled “Treatment response and long-term outcomes in biliary ascariasis: A
prospective study” was considered. This study was chosen despite no inclusion for pediatric patients in
the study population because of the lack of timely study on biliary ascariasis management among the
said age group. Nevertheless clinical presentation, pathophysiology, even ideal management for biliary
ascariasis among adults and pediatric patients do not differ.

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JOURNAL SUMMARY
TREATMENT RESPONSE AND LONG-TERM OUTCOMES IN BILIARY ASCARIASIS: A PROSPECTIVE
STUDY

Partha Sarathi Patra, Abhishek Das, S.K. Mahiuddin Ahmed, Souveek Mitra, Gopal Krishna DhalI
For vulnerable people with significant risk factors diagnosed with biliary ascariasis, ERCP with
concomitant medical treatment using anti-helminthic drugs is the most effective approach.
In this study, treatment response and long-term outcomes among patients UTZ-diagnosed
with biliary ascariasis who received conservative management of oral Albendazole 400mg single dose,
and took oral Albendazole plus ERCP were compared and analysed.
This is a single tertiary care center prospective study carried out between January 2016 and
April 2017. This study includes all patients with UTZ-diagnosed biliary ascariasis.
This study was comprised of 98 patients with confirmed biliary ascariasis. The median age was
33 years, with majority being female (90.8%) and residing in rural areas (91.8%). Majority of the study
participants belonged to the lower-middle and upper-lower socioeconomic class. Abdominal
ultrasound showed linear filling defects in bile duct in all patients (100%) with median diameter of CBD
at 9.1mm.
Conservative management utilizing oral Albendazole 400mg single dose was given among UTZ-
diagnosed patients and were instructed to return immediately if there will be persistence of symptoms
or occurrence of new onset fever or worsening abdominal pain for three days or more. Among the
patients who had recurrence of symptoms, endoscopic biliary drainage was done for worm clearance.
All patients, regardless if they had failure from conservative treatment or not, were instructed to
return after three weeks for repeat abdominal ultrasound.
Among the 98 patients who underwent conservative management, 37 patients had symptomatic
improvement: 23 had confirmed biliary clearance after 1 week, while 14 had retained worms and
underwent ERCP. Sixty-one patients had no response to initial medical management, and were
subjected to ERCP within 72 hours to prevent possible untoward complications. Therefore, 23(23.4%)
patients were responsive to conservative therapy alone, while 75 (76.6%) required ERCP.

APPRAISING DIRECTNESS

 Patients with ultrasound diagnosed biliary ascariasis showing linear filling


defects in bile duct in all patients (100%), with a median diameter of CBD
(Common bile duct) was 9.1 mm (IQR, 8.9–9.8).
 Properly informed patients who attended the Gastroenterology OPD and
Emergency services with an ultrasound diagnosis of suspected biliary
Population ascariasis.
 A repeat abdominal ultrasound (AUS) was done on the same day to confirm
the presence of biliary ascariasis. Biliary ascariasis was defined as a long,
slender filling defect in the bile duct with echogenic walls, with or without
the evidence of active movements. Patients with an alternative diagnosis
on repeat AUS were excluded.
 The study is composed of a total of 98 patients with confirmed biliary
ascariasis were included in the study. The median age of the population
was 33 [IQR (interquartile range)-25–45] years, with the majority being
Intervention and
female (90.8%) and residing in rural areas (91.8%). Majority of the study
comparison
subjects belonged to the lower-middle (56.1%) and upper-lower (31.6%)
socioeconomic class.
 There were no comparison arms in this study but rather pathways for

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grouping depending on treatment response. Patients who had good clinical
response to conservative management will only need follow-up; but those
who had persistence of symptoms or occurrence of new symptoms will
undergo ERCP which suggested failure of medical therapy.
 Patients were followed up at an interval of 3 months in outpatients for a
minimum duration of 1 year. All patients were prescribed oral Albendazole
400 mg every two months.
 Among the 98 subjects who underwent conservative management, 37
patients initially had symptomatic improvement: 23 had confirmed biliary
clearance after three weeks, while 14 had retained worms and underwent
ERCP. Sixty-one patients had no response to initial conservative
management, and they were subjected to ERCP within 72 hours. Therefore,
23(23.4%) patients were responsive to conservative therapy alone, while
75(76.6%) underwent ERCP.
 Patients who did not respond to conservative therapy had a more frequent
presentation with jaundice (p = 0.044), fever (p = 0.016) and acute
cholangitis (p = 0.007). History of ERCP (0.027) was higher among those
who did not respond to conservative therapy compared to those who had.
 Among the 75 patients who underwent ERCP for biliary ascariasis, most of
them underwent the procedure within 72 h of presentation (81.3%).
Presentation with cholangitis (41.3%) followed by persistent biliary pain
Outcome (21.3%) and retained biliary worm after three weeks (18.6%) were the most
common indications of ERCP.
 Complete biliary clearance during ERCP was achieved in 65(86.7%) patients,
while the remaining 10 patients underwent repeat ERCP after 3 weeks for
completion of biliary clearance. None of the patients required surgical
intervention.
 During ERCP, worm extraction from the biliary tree was achieved in
69(92.0%) patients, among whom 38 patients had dead worms, and 31
patients had live worms extracted from the bile ducts. On comparison of
different parameters between these group, patients with dead worm
extracted from bile duct had a more frequent presentation with acute
cholangitis (76.3% vs 22.5%, p = 0.000), jaundice (42.1% vs 19.3%, p =
0.044) compared to those with live biliary worms. Bile duct calculi were
more significantly associated with dead worms compared to live worms
(50.0% vs 12.9%, p = 0.001).
 This is a single tertiary center prospective study
 Independent sample t-test (for parametric data) or Mann Whitney U test
(for nonparametric data) were used for the Comparison between two
groups.
Method
 Categorical variables were presented as numbers and percentages and
analyzed using the Chi-square test or Fisher’s exact test.
 Bivariate logistic regression analysis was used to assess the risk factors of
long-term events in biliary ascariasis.

JOURNAL CRITICAL APPRAISAL

Question Tool Answer Explanation


A. Are the results of the study valid?
Did the trial address a clearly focused Yes This study addressed its main point of

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issue? evaluating outcomes of the management of
biliary ascariasis and determines the risk
factors for the development of recurrent
biliary events. The objective of the study was
clear and direct to the point; and, were all
met.
There was no sample randomization done. The
methods employed a purposive sampling due
Was the cohort recruited in an to the design of the study.
No
acceptable way? The inclusion criteria utilized diagnostic
imaging to confirm patients with biliary
ascariasis.
Proper diagnostic modality was used to
Was the exposure accurately measured confirm diagnosis with clear radiographic
Yes
to minimize bias? findings to include patients who qualified for
sampling.
Personal information of the patients was
acquired and handled with confidentiality in
Was the outcome accurately measure to
Yes order to aid in determining association
minimize bias?
between treatment outcome and
demographic factors.
Have the authors identified all important There were no confounding factors identified
N/A
confounding factors? in the study
Have the authors taken account of the There were no confounding factors identified
confounding factors in the design and/or N/A in the study
analysis?
Nine patients were lost to follow-up while the
Was the follow-up of the subject
No rest completed at least 12 months of follow-
complete enough?
up.
The follow-up period is long enough for
possible reinfection to occur and time window
for parasitic development to be detectable
Was the follow-up of the subject long
Yes with laboratory means. Reinfection post-
enough?
treatment usually occurs after 4 months, and
complete reinfection occurs after 7 to 9
months from treatment.
B. What are the results of the study?
1. About one-fourth of the patients with symptomatic
biliary ascariasis responded to conservative
treatment with analgesics and anti-helminthic
drugs. Patients who did not respond to initial
medical management had a significantly higher rate
of presentation with obstructive jaundice and
cholangitis with elevated markers of inflammation,
What are the results of the study?
suggesting incomplete biliary clearance with
medical treatment.
2. ERCP with complete biliary clearance was
successful in 86.7% of the patients who had failed
medical management.
3. Presence of dead worms in the bile duct was
significantly associated with the presentation of

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acute cholangitis, jaundice and biliary calculi
compared to live worms.
4. The median duration of the follow up was 16
months, during which about two-thirds of the
patients were
5. Bivariate logistic regression analysis was used to
assess the risk factors of long-term events in biliary
ascariasis. This analysis showed that socioeconomic
status and duration of follow-up were independent
risk factors for the development of events during
follow up of biliary ascariasis patients. The risk of
biliary events was higher in patients with a lower
socioeconomic status (OR = 0.78, p = 0.023) and
with longer duration of follow up (OR = 1.16, p =
0.001).
C. Will the results of the study help locally?
The country where this study was carried out
was a developing country, thus this study can
be employed in ours.
In one study performed in some provinces in
Luzon, parasitologic examination revealed the
Can the results be applied to the local prevalence of Entamoeba histolytica/dispar
Yes
population? (78.2%), Ascaris lumbricoides (34.5%),
Hookworm (18.2%), Trichuris trichiuira (14.5%)
and Taenia sp. (1.8%).
The parasite burden of these studies in our
country is a reliable indicator of the
applicability of the study in our nation.
Many studies and guidelines also employed
similar approach in the management of
Do the results of this study fit with other
Yes ascariasis, although others studies suggest
available evidence?
simultaneous removal of the worm upon
diagnosis of biliary ascariasis with ERCP.
1. This study will provide options for treatment, and
provide a time frame for the ideal initiation of ERCP
in case of failure of conservative management.
What are the implications of this study
2. This study also provides substantial information on
for practice?
the prognosis of biliary ascariasis managed either
with medical therapy alone or with ERCP or vice
versa.

CONCLUSION

This study shows that lower socioeconomic status and longer duration of follow-up were
independent risk factors for the development of further biliary events. Therefore, the importance of
public awareness, using proper sanitary measures and hand hygiene in this population to prevent
recurrent biliary parasitosis could not be overemphasized. Similar to this study, I can also suggest long
term monitoring of abdominal status for recurrence of abdominal pain or new onset symptoms. Such
recurrence will prompt repeat abdominal ultrasound to determine reinfection. I also suggest repeat
deworming after 2 weeks with Mebendazole to prevent reinfection.

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Ascariasis is a clear manifestation of poverty. Medical therapy is futile if patients will only go
back to the place that contributed to their infection. Political involvement striving for community-wide
treatment and provision of safe water, environmental sanitation, hygiene education, and regular
deworming is the most efficient strategy to reduce morbidity and eliminate underlying cause of
poverty-related diseases.

“ If poverty is a disease that infects the entire community

in the form of unemployment and violence,

failing schools and broken homes,

then we can’t just treat those symptoms in isolation.

We have to heal that entire community.


- President Barack Obama

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