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The informed patient
What you
should know
about gallstone
treatment
Publisher
www.falkfoundation.org
© 2016 Falk Foundation e.V.
All rights reserved.
14th edition 2016
The informed patient
What you
should know
about gallstone
treatment
Compiled by
Prof. Dr. Michael Sackmann
Bamberg (Germany)
Author’s address:
Prof. Dr. M. Sackmann
Medizinische Klinik II
Klinikum der Sozialstiftung Bamberg
Buger Str. 80
96049 Bamberg
Germany
The informed patient
Contents
Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
The gallbladder: Where it is and what it does . . .
6
How do gallstones develop? . . . . . . . . . . . . . . . . 10
Not all gallstones are alike . . . . . . . . . . . . . . . . . . 13
Treatment options for gallstones . . . . . . . . . . . . .
– Oral dissolution of gallstones using drugs . . . . . .
– Shockwave lithotripsy (ESWL) . . . . . . . . . . . . . . .
– Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
– Bile duct stones . . . . . . . . . . . . . . . . . . . . . . . . . .
15
16
22
25
27
Can gallstone recurrence be prevented? . . . . . . 28
Dietary advice . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
A final word . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
3
Foreword
Dear patient,
Gallstones are much more common than you might
think: In fact, about one in five adults living in Western
industrial nations will at some point in their lives develop
stones in the gallbladder or elsewhere in the biliary
system.
Many people affected by gallstones are completely
unaware of this fact as only about 20% experience
typical symptoms. These so-called “silent gallstones”
may, however, become “loud” – cramping abdominal
pain, colic and potential derangements in the function
of the gallbladder, liver or pancreas demand an accurate diagnosis and, in some cases, prompt treatment.
4
The informed patient
Gallstones: How they form and – what can be done?
Surgery: Removing the gallbladder together with the
gallstones?
Fragmenting the stones with shockwaves or dissolving them with drugs – or both?
Can the recurrence of gallstones be prevented?
This brochure will answer these and other questions,
and update you on the latest advances in gallstone
therapy.
You will not only learn about the function of your
gallbladder but also come to better understand the
therapeutic options.
If, after reading this brochure, you still have questions,
please consult your physician who will provide further
assistance.
Falk Foundation e.V.
Patient Service
5
The gallbladder: Where it is
and what it does
The gallbladder lies in the upper right corner of the
abdomen, just beneath the liver. Its function is easy to
describe: It collects and concentrates the bile that
is produced by the cells in the liver and drains through
the ducts of the biliary tract into the gallbladder. When
we take our meals, the gallbladder then doses this concentrated digestive juice, releasing it into the duodenum
(the first segment of the small bowel or intestine) to aid
in digestion.
Liver
Gallbladder
Position of the gallbladder and liver.
6
Bile and gallbladder
Liver
Stomach
Gallbladder
Stones
Bile duct
Duodenum
Entrance to
duodenum
Schematic representation of the gallbladder, stomach
and liver.
7
Why do we need the gallbladder’s
reservoir function?
Each day, the liver produces about a liter of bile.
The gallbladder functions to collect, thicken and store
this bile.
As omnivores, humans have developed a complex
system to digest our food, from adequate mastication
(chewing) to gastric juice and intact intestinal function.
The bile fluid is another crucial component of this system.
Liver:
500–1100 ml/day
Bile
Oral cavity:
1000–1500 ml/day
Saliva
Stomach:
2000 ml/day
Gastric juice
Duodenum
Pancreas:
1000–1500 ml/day
Pacreatic juice
Small intestine
Colon
8
Bile and gallbladder
Because we eat at different times and in different
amounts, we require an adequately large supply of bile
and other digestive juices to meet the varying needs
of our digestive system.
The bile is especially important in helping the body
absorb dietary fats and fat-soluble vitamins. When we
eat, the gallbladder contracts, expelling the concentrated
bile through the common bile duct into the duodenum.
Here, the bile mixes with the chyme or partially digested
food exiting the stomach.
The result is a mixture of chyme and bile in which the
nutrients from the food more completely dissolve and
can thus be more thoroughly digested. Bile is rich in
substances known as emulsifiers that assist in dissolving
the food, including bile acids as well as cholesterol,
pigments, proteins, lecithin, salts and water.
9
How do gallstones develop?
The answer to this question is also quite simple. Gallstones are the result of an imbalance in the composition
of the bile, which may, however, have many causes.
Bile is a complex solution containing many individual
components. These substances remain dissolved only
as long as cholesterol, bile acids and other components
of the bile remain in exact balance and the gallbladder,
by contracting regularly, keeps these substances well
mixed and empties normally into the duodenum.
Many factors can lead to an imbalance between the
individual components:
– Disturbances in the production or transport of
the bile in the liver, e.g. by high-calorie diets too
rich in fat
– Disturbances in the gallbladder’s function of
concentrating the bile or poor mixing of the bile
fluid, e.g. in diabetes mellitus or other metabolic
disorders
– Loss of bile acids in other disorders, e.g. after
surgery on the small bowel or Crohn’s disease
– Congenital (inborn or genetic) changes
As a result of these disorders, microscopic crystals
begin to deposit in the gallbladder. Once formed, these
small gallstone crystals may continue to grow over the
ensuing months and years. Usually, you are not even
aware that this is happening. Only when the gallbladder
can no longer contract normally or when its outlet is
partially or completely blocked by a stone is there a backup in bile flow. This is when the painful symptoms begin.
10
Gallstone formation
Who is at increased risk
of developing gallstones?
Persons consuming a high-calorie diet and especially
those whose diets are rich in fat have a significantly
higher risk of developing stones.
Conversely, an increased amount of cholesterol in the
bile also occurs during periods of prolonged fasting.
A diet low in fat less often triggers emptying of the
gallbladder, resulting in further “thickening” of the bile
fluid. The tendency for gallstone formation is generally
increased when a high cholesterol concentration in
the bile is not balanced by the increased synthesis
of bile acids.
Bile acids are normally re-absorbed in the bowel. Thus,
chronic diseases of the small bowel or colon, such as
Crohn’s disease or ulcerative colitis, or surgical removal
of sections of bowel may result in increased loss of
these important substances.
The following groups have an increased risk of developing gallstones:
–
–
–
–
–
–
Overweight or obese persons
Patients with metabolic disorders
Patients with diabetes mellitus
Patients with liver diseases (cirrhosis, hepatitis)
Patients with disorders of the small bowel or colon
Persons participating in a strict weight reduction diet
An increased risk of developing gallstones also exists
during pregnancy.
11
This is probably due to the profound metabolic changes
during pregnancy, such as:
– Changes in the woman’s hormonal status
– Restrictions in the contractility of the gallbladder due
to the increasing size of the unborn child
Women in general have a higher risk of developing
gallstones than do men. This is again probably due to
hormonal differences.
Over the past few years, researchers have identified
clear genetic factors that may serve to explain a familial
tendency to developing gallstones.
We have now covered the many different causes for
the development of gallstones. The next chapter
will discuss the different types of gallstones and how
these affect the range of therapeutic options.
.
12
Gallstone composition
Not all gallstones are alike
As we discussed above, gallstones form as a result of
an imbalance in the composition of the bile. The exact
nature of this imbalance determines whether the resulting
stones are made up predominantly of cholesterol or
pigments (bilirubin). In addition, stones may contain
different amounts of salts (e.g. calcium), components
of mucus (mucins) and proteins.
Stones may also be of mixed composition, yielding
a wide range of intermediate stone varieties that differ
from patient to patient.
The following table and illustrations provide an overview
of the main gallstone types:
Type
Main component
Frequency
Cholesterol stone
Cholesterol
70–90%
Mixed stone
Cholesterol,
pigments
10–30%
Pigment stone
Pigments,
calcium, mucins
5–10%
13
External view
Cross-section
Radial stone
“Bucket stone”
Faceted stones
“Mulberry stone”
Pigment
stones
Gallbladder
sludge
Different types of human gallstones.
Differences in gallstone composition have therapeutic
consequences, which we will now discuss.
14
Gallstone treatment
Treatment options for gallstones
Treatment options depend on the composition of
a patient’s gallstones and the severity of the disease.
In individual cases, the patient’s physical constitution
will be decisive in selecting the most appropriate treatment option.
As you will learn in the following sections, there are a
variety of effective options available today for treatment
of gallstones:
–
–
–
–
Oral dissolution therapy (drugs)
Shockwave lithotripsy
Surgery
Adjuvant dietary measures
“Silent” gallbladder stones, i.e. those that have never
caused any symptoms, it is important to note, are observed but, as a general rule, do not require treatment.
It is only when gallbladder stones become symptomatic
that they are treated. With few exceptions, stones
located in the bile ducts require immediate treatment.
15
Oral dissolution of gallstones
using drugs
The principle: Gallstone formation in reverse
Bile acids, an important component of the bile, are
produced by the liver to emulsify cholesterol, making it
more soluble.
Stones consisting predominantly of cholesterol crystals
can dissolve if litholytic (“stone-dissolving”) bile acids
are administered regularly in highly purified form, thus
reversing the process of stone formation.
One bile acid, ursodeoxycholic acid (UDCA), has been
shown to be particularly suitable for this treatment
method.
Which stones are most suitable for oral dissolution
therapy?
Patients whose gallstones consist predominantly of
cholesterol respond particularly well to treatment
with UDCA. Because they contain little or no calcium,
these gallstones are seen either very faintly or not
at all on conventional x-rays, but they can be easily
visualized and located using ultrasound.
16
Oral dissolution therapy
Cholesterol gallstone: Light in color and somewhat
translucent.
Multiple floating
gallstones
(less than 5 mm
in diameter)
in the fluid-filled
gallbladder
(x-ray image).
17
Ideally suited for oral dissolution therapy are the so-called
“floating” gallstones. Composed mainly of cholesterol,
their density corresponds to that of the bile itself. Hence,
these stones do not sink to the bottom of the gallbladder.
The success of oral dissolution therapy with UDCA has
been shown to be highest when certain pre-requisites
are met:
– Maximum stone diameter should not exceed
five millimeters
– Total stone mass should not exceed one-third
of the volume of the gallbladder
– The gallbladder must be fully functional
(complete contraction after a test meal)
– The bile ducts must be free of obstruction
– Patients should not be taking certain medications
(clofibrate, antacids, colestyramine, estrogen
preparations)
Important facts to know about the oral dissolution
of gallstones
First, patience is a virtue: Just as the development
of gallstones takes months or even years, dissolution
of gallstones with the help of bile acids does not occur
overnight.
Duration of oral dissolution therapy
Depending on the size, type and number of gallstones,
therapy may take between three months and one year.
Maximum stone size is the main determinant of the
duration of therapy.
18
Drug therapy
Regular and consequent compliance with your
medication is the key requirement for successful
stone dissolution. You will take most of your
medication in the evening, since it is especially
at night that the liver produces bile fluid of
a type that promotes the formation of gallstones.
Severe abdominal pain, fever or chills, as well as dark
urine may point to a stone trapped in the bile duct
that obstructs the outflow of the bile. This causes
a back-up of bile into the liver. If you experience
these symptoms, you must seek medical attention
immediately!
No-fat “crash” diets, though they produce rapid
weight loss, are accompanied by an increased risk
of gallstone formation. Ask your doctor about reducing this risk with UDCA. This treatment is normally
continued at least until weight stabilization has
occurred.
19
Advantages of oral dissolution
therapy
Therapy with ursodeoxycholic acid (UDCA) is practically free of side effects and has been proven safe
and effective in many international clinical studies.
It is certainly the gentlest method of treating
gallbladder stones.
Compared to other forms of therapy, especially surgery,
oral dissolution with UDCA offers patients a number
of important advantages:
– Preservation of the gallbladder and normal
bile flow
– Avoidance of surgery
– Avoidance of its associated risks and consequences (anesthesia, complications, scars,
dietary restrictions)
– No pain, no time off from work
Success rates and follow-up examinations during
oral dissolution therapy
Patients who meet the above selection criteria and
regularly take their prescribed medication can expect
successful oral dissolution of gallstones in about
30–70% of cases.
Female patients should avoid becoming pregnant
during therapy.
20
Drug therapy
The efficacy of oral dissolution therapy, measured by
reduction in stone size, is normally monitored after three
to six months by ultrasound. Treatment is continued
only if there has been a significant reduction in stone
size.
Before beginning oral dissolution treatment, patients
and their doctors should discuss alternatives, such
as surgery, which remains the standard treatment.
Because the gallbladder is preserved, patients should
be fully aware of the risk of stone recurrence following
successful oral dissolution therapy with UDCA.
A final request:
Oral dissolution therapy for gallstones is only successful
when you take your medication regularly and as prescribed. Please do not alter with the dosage and never
simply discontinue therapy without first consulting your
physician. In such cases, gallstones will continue to
grow and may result in severe, acute symptoms that
may even require surgery!
21
Treating gallstones with shockwaves
(lithotripsy, ESWL)
In Germany, extracorporeal shockwave lithotripsy (ESWL)
has been used in the treatment of gallstones since
1985. The method was initially introduced in 1980 for
the treatment of kidney stones.
The aim of this method is to reduce the size of gallstones
without resorting to surgical intervention. One very effective way of doing this is by the use of special shockwaves
originating from a generator located outside the body,
hence “extracorporeal”.
The principle:
Precisely-focused shockwaves shatter the gallstone
into tiny fragments.
Schematic representation of shockwave therapy.The
patient lies on a water cushion above the shockwave
reflector. Shockwaves are generated following precise
placement of the stone in the shockwave focus.
22
Shockwave lithotripsy
Ultrasound image of the gallbladder with a solitary stone
(image center) in the gallbladder.
The treatment:
A treatment session takes about 30–60 minutes. During
treatment, the patient lies atop a shockwave reflector
that focuses the shockwaves exactly on the stone.
With the stone under constant monitoring, shockwaves
are generated. The disintegration of the stone is observed
using either ultrasound or radiological methods.
Depending on stone type, size and number, one or
sometimes several treatments may be necessary before
the stone is pulverized.
23
Which stones are suitable for shockwave treatment?
The technique is especially suitable for patients with large
stones trapped in the bile ducts that have not been
amenable to treatment with other methods, such as
endoscopic stone removal. This may apply especially
in the case of stones trapped high in the liver or unable
to pass a narrow point in the bile duct.
Because of the very high rate of recurrent stone formation, this method is no longer recommended for the
treatment of gallbladder stones.
24
Surgery
Surgical treatment of gallbladder
stones
This is what you should know about the surgical treatment of gallstones:
– The surgical removal of the gallbladder (cholecystectomy) is today considered the treatment of choice
for gallbladder stones.
– The surgical removal of the gallbladder is one of the
most frequently performed and safest surgical procedures.
– For patients presenting with highly acute symptoms,
surgical removal of the gallbladder may often be the
only feasible and life-saving option. Thus, surgery has
retained its pre-eminent position in the treatment of
gallstone disease.
Nearly 100,000 cholecystectomies are performed
each year in Germany, making this a “routine” procedure
of modern surgery. As with any surgical procedure,
however, problems or complications may occur in
individual cases. Before making any decision, an open
and frank discussion between you and your doctor will
comprehensively address your questions and concerns
before undergoing this surgical procedure. Your doctor
will also discuss with you the necessity of surgery and
answer any questions you may have regarding the
procedure itself.
25
Today, most operations to remove the gallbladder are
performed using an endoscopic (“laparoscopic”) surgical
technique. This requires several very small incisions
through the abdominal wall and the navel (“keyhole surgery”). Most patients are therefore spared the unpleasant
large scars left after conventional open cholecystectomy.
The required length of inpatient hospitalization following
the surgery has also been significantly shortened and
usually lasts no more than a few days.
The surgical risk associated with laparoscopic gallbladder
operations depends to a great extent on patients’
general health and other disorders. Damage to the bile
ducts, a feared complication, occurs only rarely.
26
Bile duct stones
Removing stones from the bile ducts
Gallstones in the bile ducts are today typically removed
using endoscopic techniques. The basic technique
may already be familiar to you from experience with
endoscopic examinations of the stomach (gastroscopy)
or bowel (colonoscopy).
When the objective is to treat a stone in the bile duct,
the endoscope is advanced into the small bowel and,
having opened the mouth of the bile duct (papillotomy),
a tiny basket is inserted to “capture” and remove the
stone. The stone is then released into the small bowel
and allowed to pass with
the stool. The determination of the stone’s
position and whether all
stones have been successfully removed is
performed using a radiological method known
as fluoroscopy.
Large stones, as well as
those that are trapped
or located high in the
liver itself or at a narrow
point in the bile duct
can also in many cases
be safely and effectively
fragmented using shockwaves or lasers (highenergy light beams)
and then removed using
the above-described
method.
X-ray image showing the
endoscope and stones
in the bile duct.
27
Can gallstone recurrence
be prevented?
One serious problem remains: Even after successful
treatment and compete disappearance of the gallbladder
stone the underlying process of stone formation cannot
be prevented.
As we have discussed above, the ultimate cause of stone
formation to a great extent lies in metabolic disturbances
in the liver. The exact molecular and biochemical processes in the liver cells that are responsible for the production of bile fluid of a type that promotes stone formation have long been the subject of intense scientific
research but are still far from being adequately understood. More recently, a number of important genetic
factors that play a role in gallstone formation have been
identified.
Comprehensive studies of stone recurrence in patients
following successful stone clearance have repeatedly
shown that 30–50% of successfully treated patients will
again develop gallbladder stones within 5 years. Of
these, however, only a minority again developed pain.
The high recurrence rate may partially be explained by
the fact that very small stones are often “invisible” to
diagnostic imaging and may thus be overlooked. These
patients are therefore erroneously declared stone-free
and their therapy terminated prematurely.
28
Stone recurrence
Continuing oral dissolution therapy
This leads to the logical next conclusion: Treatment
with UDCA should be continued for a period of about
3–6 months after clear evidence of complete stone
clearance at ultrasound.
It is currently being studied whether longer-term, reduceddose treatment with drugs can reduce the risk of stone
recurrence. Long-term findings, however, remain unavailable at this time.
Patients with a strong tendency to stone recurrence
are usually advised to consider surgical removal of the
gallbladder.
29
Nutrition tips to prevent stone
recurrence
Certain dietary measures may reduce your risk of
gallstone recurrence:
– Avoid becoming overweight: Overweight patients
are at higher risk of stone recurrence.
– Reduce your dietary intake of cholesterol. By consuming a diet low in cholesterol, patients can do much
to extend their freedom from gallstones as long as
possible.
– Eat several small meals distributed throughout the
whole day, including a light late meal (such as a glass
of milk). This helps the gallbladder mix and empty
the bile and hinders the formation of stones.
– A high-fiber diet, rich in vegetables, facilitates the
digestive process and also counteracts the formation
of gallstones.
Therefore: Consult your physician and follow his or her
advice on diet and lifestyle!
30
The informed patient
A final word
Supporting patients and physicians in treating disorders
of the liver, stomach, bowel and biliary tract is the main
mission of the Falk Foundation e.V.
We hope that this brochure has increased yout understanding of modern therapeutic options. This, in turn,
should serve to deepen the understanding between
physicians, patients, medical researchers, the pharmaceutical industry and the general public.
Falk Foundation e.V.
Patient Service
31
U85e 14-4/2016 POP