Long-Term Effects of Iatrogenic Bile Duct Injury During Cholecystectomy

doi:10.1016/j.cgh.2009.05.014

Clinical Gastroenterology and Hepatology

Volume 7, Issue 9, September 2009, Pages 1013-1018

https://doi.org/10.1016/j.cgh.2009.05.014 Get rights and content

Background & Aims

The aim of this study was to study survival, factors influencing survival, and causes of death after iatrogenic reconstructed bile duct injury in a large population-based Swedish cohort.

Methods

Patients who underwent cholecystectomy in the period from 1965 to 2005 were identified from the Swedish Inpatient Register. The bile duct injury cohort consisted of patients with procedure codes indicating reconstructive biliary surgery within 1 year of the cholecystectomy, excluding patients with reconstruction owing to other causes than bile duct injury.

Results

Of 374,042 cholecystectomy patients, 1386 were classified as afflicted by bile duct injury requiring reconstructive surgery. Survival was significantly lower in the injured cohort compared with the noninjured cohort, with a hazard ratio of 3.73 (95% confidence interval, 3.30–4.22) at 1 year that gradually evened out thereafter. The risk of dying from liver diseases was increased 4-fold in the bile duct injury cohort compared with the general population. Older age and comorbidity increased the risk of dying, whereas the use of intraoperative cholangiogram improved survival.

Conclusions

Patients with iatrogenic reconstructed bile duct injury have a decreased survival rate compared with noninjured cholecystectomy patients. Patients' younger age, absence of other diseases, and routine use of intraoperative cholangiogram seem to be positive prognostic survival factors. These patients also may be at increased risk of dying from liver diseases, although this issue requires further study.

Section snippets

The Swedish Inpatient Register

Since 1965, the Swedish National Board of Health and Welfare has collected data on individual hospital discharges in the Swedish Inpatient Register. This register is event-based, and information on patient demographics, dates of admission and discharge, codes for discharge diagnoses, codes for surgical procedures, as well as hospital identification codes, are registered. The introduction of the register was made by region, covering 10% of all hospital discharges in 1965 with an almost linear

Study Subjects

A total of 374,042 cholecystectomies were identified from 1965 to 2005. Among these, 1386 cases of iatrogenic BDI requiring surgical reconstruction within 1 year of the cholecystectomy were identified. A majority, 251,423 (67.5%) of the cholecystectomies, were performed in women, and 795 (57.4%) of the reconstructed BDIs occurred in women. The mean age at the time of cholecystectomy was 52.6 years for all study subjects and 59.9 years for BDI cases (Table 1).

Survival Analysis

The Kaplan–Meier survival curves

Discussion

In this nationwide population-based study of 374,042 patients who underwent cholecystectomy, survival among patients with reconstructed BDI was substantially lower than among patients not injured at cholecystectomy. The risk of dying from liver disease was increased among patients with reconstructed BDI. Older age and the presence of other diseases had a negative effect, whereas neither sex, calendar period of injury, the timing of the reconstruction, nor the hospital type of reconstruction or

References (20)

M.E. Charlson et al.
A new method of classifying prognostic comorbidity in longitudinal studies: development and validation
J Chronic Dis
(1987)
V. Sundararajan et al.
New ICD-10 version of the Charlson comorbidity index predicted in-hospital mortality
J Clin Epidemiol
(2004)
R.A. Deyo et al.
Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases
J Clin Epidemiol
(1992)
L.J. Valinsky et al.
Finding bile duct injuries using record linkage: a validated study of complications following cholecystectomy
J Clin Epidemiol
(1999)
S.E. Gabriel et al.
A comparison of two comorbidity instruments in arthritis
J Clin Epidemiol
(1999)
K.A. Kern
Malpractice litigation involving laparoscopic cholecystectomyCost, cause, and consequences
Arch Surg
(1997)
D.R. Flum et al.
Bile duct injury during cholecystectomy and survival in Medicare beneficiaries
JAMA
(2003)
C.S. Huang et al.
Long-term results of major bile duct injury associated with laparoscopic cholecystectomy
Surg Endosc
(2003)
D. Boerma et al.
Impaired quality of life 5 years after bile duct injury during laparoscopic cholecystectomy: a prospective analysis
Ann Surg
(2001)
L. Barlow et al.
On the reliability of incidence figures in the national Swedish Cancer RegistryCancer incidence in Sweden 1990
(1993)

There are more references available in the full text version of this article.

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Biliary strictures are among the most troublesome complications following hepatobiliary surgery, for example, iatrogenic bile duct injury (IBDI) is a critical complication associated with laparoscopic cholecystectomy [1].
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The mean operating time for IOC across 4 studies was 11 minutes (range 6–15 minutes) [16–19]. When analyzing 20 multicenter studies (96% of which were based on American and Swedish studies), the mean rate of IOC use was 38.5% (CI = 38.5–38.6), range 12% to 88% [6,8,11,20–36]. The use of IOC from 11 multicenter studies carried out in the United States [11,20–29] revealed a mean rate of 33.2% (CI = 33.1–33.3) compared to a mean rate of 69.5% (CI = 69.4–69.6) from 4 multicenter Swedish studies [6,8,30,31].
Despite some evidence of improved survival with intraoperative cholangiography during cholecystectomy, debate has raged about its benefit, in part because of its questionable benefit, time, and resources required to complete.
An International Prospective Register of Systematic Reviews–registered (ID CRD42018102154) meta-analysis following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines using PubMed, Scopus, Web of Science, and Cochrane library from 2003 to 2018 was undertaken including search strategy “intraoperative AND cholangiogra* AND cholecystectomy.” Articles scoring ≥ 16 for comparative and ≥ 10 for noncomparative using the Methodological Index for Non-Randomized Studies criteria were included. A dichotomous random effects meta-analysis using the Mantel-Haenszel method performed on Review Manager Version 5.3 was carried out.
Of 2,059 articles reviewed, 62 met criteria for final analysis. The mean rate of intraoperative cholangiography was 38.8% (range 1.6%–96.4%).There was greater detection of bile duct stones during cholecystectomy with routine intraoperative cholangiography compared with selective intraoperative cholangiography (odds ratio = 3.28, confidence interval = 2.80–3.86, P value < .001). While bile duct injury during cholecystectomy was less with intraoperative cholangiography (0.39%) than without intraoperative cholangiography (0.43%), it was not statistically significant (odds ratio = 0.88, confidence interval = 0.65–1.19, P value = .41). Readmission following cholecystectomy with intraoperative cholangiography was 3.0% compared to 3.5% without intraoperative cholangiography (odds ratio = 0.91, confidence interval = 0.78–1.06, P value = .23).
The use of intraoperative cholangiography still has its place in cholecystectomy based on the detection of choledocholithiasis and the potential reduction of unfavorable outcomes associated with common bile duct stones. This meta-analysis, the first to review intraoperative cholangiography use, identified a marked variation in cholangiography use. Retrospective studies limit the ability to critically define association between intraoperative cholangiography use and bile duct injury.
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Small sample size and a lack of standardized reporting for patients requiring reconstruction for laparoscopic cholecystectomy bile duct injuries (LC-BDI) have limited investigation of factors contributing to loss of patency.
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Of 131 patients analysed, 103 had a successful index reconstruction and 28 required revision. There were no statistically significant differences in patient characteristics between the two groups. Days to referral and reconstruction were significantly different (p < 0.001, p = 0.001). Patients with incomplete biliary imaging more often required a revision (p < 0.001). The only independent predictor of loss of patency was incomplete depiction of the biliary tree prior to initial reconstruction (p = 0.035, OR 10.131, 95% CI 1.180–86.987). Primary and secondary patency were 98.1% and 96.4%, respectively with no differences in 30-day complications.
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: This article has an accompanying continuing medical education activity on page 915. Learning Objectives—At the end of this activity the learner should define the effect of iatrogenic bile duct injury during cholecystectomy on survival in patients and on the risk of dying from liver diseases compared to the general population.

: Conflicts of interest The authors disclose no conflicts.

View full text

Original articles—liver, pancreas, and biliary tractLong-Term Effects of Iatrogenic Bile Duct Injury During Cholecystectomy

Background & Aims

Methods

Results

Conclusions

Section snippets

The Swedish Inpatient Register

Study Subjects

Survival Analysis

Discussion

J Chronic Dis

J Clin Epidemiol

J Clin Epidemiol

J Clin Epidemiol

J Clin Epidemiol

Malpractice litigation involving laparoscopic cholecystectomyCost, cause, and consequences

Arch Surg

Bile duct injury during cholecystectomy and survival in Medicare beneficiaries

JAMA

Long-term results of major bile duct injury associated with laparoscopic cholecystectomy

Surg Endosc

Impaired quality of life 5 years after bile duct injury during laparoscopic cholecystectomy: a prospective analysis

Ann Surg

On the reliability of incidence figures in the national Swedish Cancer RegistryCancer incidence in Sweden 1990

Original articles—liver, pancreas, and biliary tract
Long-Term Effects of Iatrogenic Bile Duct Injury During Cholecystectomy