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285
1988) to 208 patients (1992–1995) and did not fi nd any differences in survival
(p = 0.54) between the two time periods [ 30 ].
Adjuvant Chemotherapy
Adjuvant therapy following curative intent resection of gallbladder cancer was queried in a recent meta-analysis [ 31 ]. This meta-analysis pooled 20 studies for a total
of 6,712 patients who underwent surgical resection of gallbladder cancer and cholangiocarcinoma [ 31 ]. Sub-group analyses were conducted for gallbladder cancer
resections comparing patients who underwent adjuvant therapy ( chemotherapy or
chemo-radiation therapy) and patients who were treated with surgery alone [ 31 ].
Overall, there was a non-statistically signifi cant trend toward improved survival
with adjuvant therapy compared to surgery alone (pooled OR = 0.74; p = 0.06) [ 31 ].
Stratifi ed meta-analysis did suggest improved survival with adjuvant therapy for
lymph node positive disease (OR = 0.49, p = 0.004) and R1 resection (OR = 0.36,
p = 0.002) [ 31 ]. Thus, adjuvant therapy should be recommended in lymph node
positive or R1 resected gallbladder cancer [ 31 ]. A SEER database analysis from
another study provided similar recommendations for adjuvant therapy in cases of
node-positive disease and consideration for patients with T2 tumors [ 32 ].
The Mayo Clinic experience of multi-disciplinary management for gallbladder
cancer is in line with reports from other institutions [ 33 , 34 ]. A retrospective review
of all surgical procedures performed for gallbladder cancer (n = 131) demonstrated
a median overall survival of 24 months for patients who underwent radical cholecystectomy compared to 6 months for simple cholecystectomy and 4 months for
palliative surgery (p < 0.0001) [ 34 ]. Overall 5-year survival was demonstrated to be
21 % for patients undergoing radical cholecystectomy compared to 6 % for patients
undergoing simple cholecystectomy (p < 0.0001) [ 34 ]. When stratifying by stage of
cancer, all stages (except Stage I) demonstrated improved survival with radical cholecystectomy over simple cholecystectomy [ 34 ]. There were 48 patients from this
cohort who received adjuvant therapy (37 %) [ 34 ]. In a separate study by the same
institution, the benefi ts of adjuvant chemo-radiation therapy following surgical
resection were demonstrated with a 5-year overall survival of 64 % compared to a
historical control of 33 % [ 33 ].
Evidence-Based Recommendations
1. Gallbladder cancer is a highly aggressive malignancy and complete surgical
resection to histologically negative margins (R0 resection) remains the standard
for potential cure. (Strong recommendation based on high grade evidence).
2. Any incidentally detected gallbladder cancer that is beyond T1a in the absence
of distant nodal (N2) or metastatic (M1) disease should be managed with further
surgical resection . T1a tumors with any positive margins or positive lymph nodes
in the cholecystectomy specimen should also be managed with further surgical
resection. (Strong recommendation based on moderate to high grade evidence).
24 Management of Incidentally Discovered Gallbladder Cancer
286
3. Multi-disciplinary referral for consideration of chemotherapy with or without
radiation therapy after surgical resection should be offered to patients with evi-
dence of lymph node metastases, R1 resection, and/or T2 or greater tumor.
(Strong recommendation based on moderate to high grade evidence).
Expert View of the Data
Poor prognostic indicators for gallbladder cancer include incomplete surgical resection (R1/R2 resection), lymph node metastases, and tumor characteristics (grade
and stage). Patients with incidentally discovered gallbladder cancer generally have
more favorable prognosis due to the early nature of their disease. Given the aggressiveness of gallbladder cancer, we would recommend complete surgical re-resection
for any tumor that demonstrates a T stage greater than T1a, positive margins, or
lymph node involvement. Controversy in the literature regarding management of T1
tumors is likely due to lack of stratifi cation of T1a from T1b tumors, the former of
which represents primarily localized disease.
The type of surgical re- resection depends on the stage and positivity of the margins. For T1b/T2 tumors, radical cholecystectomy with resection of at least 2 cm of
liver bed at the gallbladder fossa and hilar lymphadenectomy are suffi cient. The
re-excision of the bile duct would be indicated for a positive cystic duct margin on
the original specimen but should not be done routinely, as there is no survival benefi t to a procedure that is associated with increased postoperative morbidity .
Involvement of adjacent organs (T3) tumors mandates en bloc resection of all
involved organs should this be technically feasible in the absence of prohibitive
patient co-morbidities.
Controversy still exists regarding port site excision. Recurrence at the port site is
more a harbinger of carcinomatosis or aggressive disease rather than a technical
factor for incomplete excision. Our institutional bias is not to resect port sites fol-
demonstrated and it may be associated with increased long-term morbidity , such as
the development of abdominal wall hernias.
The role of chemo and/or radiation therapy should be considered primarily as an
adjunctive measure to maximize cure in patients who have undergone appropriate
surgical resection for gallbladder cancer . Chemo-radiation therapy should be considered following surgical resection in instances of R1 resection, presence of lymph
node metastasis, and/or T2 or greater stage. It may also be considered as a palliative
measure in the patient who has incidentally discovered gallbladder cancer following
a laparoscopic cholecystectomy whose physiologic or functional status would make
radical re-resection prohibitive. In patients who are staged following discovery of
incidental gallbladder cancer with potentially unresectable disease, chemo- radiation
therapy in the neoadjuvant setting may also be benefi cial for tumor down-staging
and eventual resection.
M.C. Tee and K. Reid-Lombardo
287
In summary, the primary treatment of any resectable (T1–T3) gallbladder cancer
in the absence of distant metastatic disease (N2 or M1) remains complete surgical
resection with curative intent. This includes radical re-resection for any T1a tumor
with residual disease or any tumor greater or equal to T1b stage. A potential role for
postoperative observation is the completely excised T1a tumor that has no evidence
of lymph node metastasis after simple cholecystectomy . Chemo-radiation therapy
would be indicated in the adjuvant setting for incomplete excision, lymph node
metastasis, more advanced stage (T2 or greater), or inability to undergo further
surgical resection (due to technical or patient factors).
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7. Lee SE, Jang JY, Lim CS, Kang MJ, Kim SW. Systematic review on the surgical treatment for
T1 gallbladder cancer. World J Gastroenterol. 2011;17(2):174–80. PMCID: 3020370.
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carcinoma does not warrant radical resection. Br J Surg. 2001;88(5):675–8.
10. Bartlett DL, Fong Y, Fortner JG, Brennan MF, Blumgart LH. Long-term results after resection
for gallbladder cancer. Implications for staging and management. Ann Surg. 1996;224(5):639–
46. PMCID: 1235441.
11. Dixon E, Vollmer Jr CM, Sahajpal A, Cattral M, Grant D, Doig C, et al. An aggressive surgical
approach leads to improved survival in patients with gallbladder cancer: a 12-year study at a
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12. Fong Y, Jarnagin W, Blumgart LH. Gallbladder cancer: comparison of patients presenting
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13. Goetze TO, Paolucci V. Immediate re-resection of T1 incidental gallbladder carcinomas: a
survival analysis of the German Registry. Surg Endosc. 2008;22(11):2462–5.
14. Hari DM, HJ, Chiu CG, Leung AM, Sim M, Bilchik AJ. A 21-year analysis of T1 gallbladder
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24 Management of Incidentally Discovered Gallbladder Cancer
291© Springer International Publishing Switzerland 2016
J.M. Millis, J.B. Matthews (eds.), Diffi cult Decisions in Hepatobiliary
and Pancreatic Surgery, Diffi cult Decisions in Surgery: An Evidence-Based
Approach, DOI 10.1007/978-3-319-27365-5_25
Chapter 25
Gallstone Ileus
Pierre F. Saldinger and Alexander Itskovich
Abstract Gallstone ileus is a rare form of bowel obstruction caused by an impacted
gallstone. It requires two critical elements: a cholecysto-enteric fi stula and a gallstone of suffi cient diameter to migrate and obstruct the intestinal lumen. Classically,
gallstone ileus was addressed by relieving the blockage and closing the fi stula.
However, because the typical presentation involves elderly patients with numerous
comorbidities, lengthy, complex procedures are often poorly tolerated. Obviating
the exploration of the fi stula has been proposed as a means of decreasing postoperative morbidity and mortality. Although no prospective trials have performed on the
subject, several retrospective reviews support this conclusion.
Keywords Gallstone ileus • Cholecystoduodenal fi stula • Cholecystointestinal fi stula • Cholecystosigmoid fi stula • Bouveret syndrome
Introduction
Gallstone ileus represents approximately 1 % of all patients presenting with small
bowel obstruction. Greater than 70 % of patients are women. The majority of cases
affect patients older than 65. The location of the fi stula represents the entry point of
the gallstone into the alimentary tract. The most common sites (in descending order)
include the duodenum, stomach, colon, and small intestine. The stone will subsequently migrate and lodge in the narrowest point of the intestine that is distal to the
fi stula [ 1 , 2 ].
The area of stone impaction may represent an anatomic narrowing (e.g., ileocecal valve) or the result of a previous pathologic process (strictures, adhesions).
Greater than 60 % of stones lodge in the vicinity of the ileocecal valve. Other sites
P. F. Saldinger (*)
Department of Surgery, New York Presbyterian Queens , Weill Cornell Medical College ,
56-45 Main Street , Flushing , NY 11355 , USA
e-mail:
Pfs9003@med.cornell.edu
A. Itskovich
Department of Surgery , The Brooklyn Hospital Center , 121 Dekalb Ave , Brooklyn , NY , USA
292
of obstruction include the jejunum (16 %), stomach (14 %), colon (4 %) and duodenum (3.5 %) [ 1 , 2 ].
Presentation varies largely depending on the level of obstruction. Patients most
commonly complain of nausea, vomiting and abdominal pain . A careful history will
often suggest prior episodes of biliary colic or acute cholecystitis . Most patients will
present with abdominal distention. Vital signs and laboratory work often reveal a
systemic infl ammatory response and evidence of dehydration.
Rigler’s classic X-ray fi ndings of pneumobilia, small bowel obstruction and a
right iliac fossa gallstone is only present in 30–35 of cases. CT is the diagnostic
study of choice. It is a highly accurate method of establishing the diagnosis . Three
criteria must be met. The CT must show (1) evidence of bowel obstruction with (2)
the presence of an ectopic gallstone (rim calcifi ed or totally calcifi ed) and an (3)
abnormal gallbladder with the presence of an irregular wall or an air fl uid level.
With all three elements present, the sensitivity and specifi city of CT are 93 % and
100 % respectively. For a stone to become impacted, it typically has to measure at
least 2 cm in diameter [ 1 , 3 , 4 ].
Preoperative management begins with immediate crystalloid resuscitation, nasogastric tube drainage and the correction of electrolyte abnormities. In the setting of
hemodynamic instability secondary to severe sepsis or septic shock, patients may
require invasive hemodynamic monitoring. Once resuscitated, patients are expeditiously taken to the operating room where they undergo general endotracheal
anesthesia.
The abdomen is entered and the small bowel evaluated. The transition zone is
noted and the bowel proximal to the obstruction is assessed for additional stones. A
longitudinal incision is made on the small bowel proximal to the site of obstruction.
The stone is milked into the enterotomy which is subsequently closed in a transverse fashion. If the segment affected has evidence of bowel ischemia, a resection
with primary anastomosis is performed.
Electing to perform a resection of the cholecystoenteric fi stula is controversial.
The planes are often obscured secondary to chronic infl ammation and exploration
often substantially increases operative time. In the open approach, the gallbladder is
dissected in a top down fashion until the structures in the Triangle of Calot are identifi ed. The cystic duct and artery are dissected and clipped. The fi stula is dissected
from the involved structure (usually the duodenum). The area of the fi stula is
debrided and the enterotomy repaired in a transverse fashion. Multiple critical structures may be at risk during the dissection.
Search Strategy
A search of the English literature was conducted to identify data on the management
of Gallstone Ileus published between 1994 and 2014 utilizing the PICO outline
(Insert Table
25.1 ). PubMed was utilized to conduct all queries. Terms used in the
search were “Gallstone Ileus”, “Cholecystoduodenal fi stula”, “Cholecystogastric
fi stula”, “Cholecystosigmoid fi stula” and “ Bouveret Syndrome ”. No randomized
P.F. Saldinger and A. Itskovich
293
trials were identifi ed. Three large retrospective reviews were identifi ed. The remainder of the literature is primarily small case series and case reports. All data was
evaluated based on the GRADE system.
Results
Enterolithotomy vs Enterolithotomy with Cholecystectomy and Cholecysto-Enteric Fistula Closure
In a 2014 retrospective review (largest to date), Halabi et al. queried the national
inpatient sample and identifi ed 3,268 cases of Gallstone Ileus occurring between
2005 and 2009. Stone extraction alone occurred in 62 % of patients. Nineteen percent of patients underwent closure of their cholecysto-enteric fi stula. Nineteen percent of patients required small bowel resection . The most common complication
was acute renal failure (30 %) and the perioperative mortality rate was 6.67 %. On
multivariate analysis, closure of the enteric fi stula was associated with a higher
mortality rate (odds ratio 2.86).
In a 2013 retrospective review of the NSQIP Database, Mallipeddi et al. evaluated 127 patients that presented with gallstone ileus from 2005 to 2010. They noted
an overall morbidity and mortality rate of 35.4 % and 5.5 % respectively. No difference in mortality was noted in patients that underwent fi stula closure. However, the
fi stula closure group did experience longer operative times, postoperative hospitalization times and minor complications. The most common complications were urinary tract infections and surgical site infections [
5 ].
In their 1994 review, Reisner et al. present 1001 reported cases of gallstone ileus.
They reported a mortality rate of 16.9 % for the fi stula closure group and an 11.7
mortality rate for the enterotomy group alone. In addition, they report a gallstone
ileus recurrence rate of less than 5 %. They conclude that simple enterolithotomy is
both safe and effective in dealing with Gallstone Ileus [ 1 , 2 , 4 ].
Recurrent Gallstone Ileus
The literature for recurrent gallstone ileus is made up largely of case reports. Reisner
et al. published the largest series with 1001 patients and reports a recurrence rate of
5 %. Additionally, they report that approximately 10 % of patients require reoperation [ 1 ].
Table 25.1 Literature search outline utilizing the PICO method
P (patients) I (intervention) C (comparator) O ( outcomes)
Patients with
gallstone ileus
Enterolithotomy with cholecystectomy
and cholecystoenteric fi stula closure
Enterolithotomy
alone
Morbidity and
mortality
25 Gallstone Ileus
294
Minimally Invasive Techniques
The feasibility of laparoscopic approach has been demonstrated in several case
reports. Potential limiting factors include patient stability, capacity to tolerate pneumoperitoneum, restricted working space, and the surgeons laparoscopic comfort
level. Both intracorporeal and extracorporeal anastomotic methods have been
described. It is critical that the surgeon be comfortable fully examining the bowel
laparoscopically as up to 5 % of patients will have additional stones present proximal to the obstruction.
Several reports have demonstrated the feasibility of endoscopic extraction and
fragmentation in selected cases. Specifi cally, extraction may be successful in the
setting of Bouveret syndrome (gallstone ileus causing gastric outlet obstruction).
The role of endoscopy and criteria for its utilization have not been clearly defi ned
[ 6 – 11 ].
Recommendations
Although limited in terms of quality of evidence , the literature to date suggests that
enterolithotomy alone is suffi cient in the management of gallstone ileus (level of
recommendation; weak). This is supported by both retrospective data showing a
higher incidence of complications with fi stula closure and the low rates of reported
recurrence with enterolithotomy alone.
The limited literature to date suggests a low recurrence rate after enterolithotomy
alone. However, no conclusion can be based on the available data and the question
of whether the cholecysto-enteric fi stula should be addressed in an interval fashion
remains unanswered.
Multiple case reports have demonstrated the feasibility of both the laparoscopic
and endoscopic approach in selected cases. Bouveret Syndrome in particular seems
amenable to endoscopy . Both the enterolithotomy and repair of a cholecystoduodenal fi stula have been performed laparoscopically. No study evaluating the laparoscopic versus open approach has been published to date.
A Personal View of the Data
Gallstone Ileus affects primarily elderly patients with multiple comorbidities.
Addressing the small bowel obstruction should be the surgeon’s priority. Exploring
the area of fi stulization is usually unnecessary and is best avoided. Although the
available data cannot be used to make any defi nitive conclusions, it supports enterolithotomy alone.
P.F. Saldinger and A. Itskovich
295
Even in experienced hands, the obliteration of anatomical planes in the right
upper quadrant makes safe resection of a cholecysto-enteric fi stula challenging. In
a patient population that is often in extremis with poor physiologic reserve, the consequences of lengthy, complex operations may be considerable.
Summary of Recommendations
• Patients with gallstone ileus should be managed with enterolithotomy alone (evi-
dence quality low; weak recommendation)
References
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1994;60(6):441–6.
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AN. Surgery for gallstone ileus: a nationwide comparison of trends and outcomes. Ann Surg.
2014;259(2):329–35.
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tations. JAMA. 1941;117:1753–9.
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CY. Value of CT in the diagnosis and management of gallstone ileus. World J Gastroenterol.
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JH. Gallstone ileus successfully treated with endoscopic fragmentation by using double balloon endoscopy. Gastrointest Endosc. 2011;74(1):228–30.
10. Muratori R, Cennamo V, Menna M, Cecinato P, Eusebi LH, Mazzella G, Bazzoli F. Colonic
gallstone ileus treated with radiologically guided extracorporeal shock wave lithotripsy followed by endoscopic extraction. Endoscopy. 2012;44 Suppl 2:e88–9. UCTN.
11. Reinhardt SW, Jin LX, Pitt SC, Earl TM, Chapman WC, Doyle MB. Bouveret syndrome com-
plicated by classic gallstone ileus: progression of disease or iatrogenic. J Gastrointest Surg.
2013;17(11):2020–4.
25 Gallstone Ileus