Matter for Debate

A selective approach to histopathology of the gallbladder is justifiable

F.P. Dix, I.A. Bruce, A. Krypcyzk* and S. Ravi
Department of Surgery, Blackpool, Victoria Hospital, *Department of Histopathology, Blackpool Victoria Hospital, Blackpool, U.K.

Correspondence to: Mr F Dix, Specialist Registrar / Research Fellow, Research and Education Building, Wythenshawe Hospital, Southmoor Road, Wythenshawe, Manchester, Cheshire, M23 9LT, U.K. Email: fdix@fs1.with.man.ac.uk

Introduction Patients and Methods  Results

Discussion Conclusions References

Keywords: Gallbladder, cholecystectomy, histology
Surg J R Coll Surg Edinb Irel., 1 August 2003, 233-235

Background: Recent changes in the NHS have led to a considerably increased workload for histopathologists prompting the publication of guidelines from the Royal College of Pathologists regarding specimen analysis. In most hospitals, cholecystectomy specimens are routinely sent for histology regardless of whether or not there is any visible macroscopic abnormality suggestive of malignancy. Our aim was to assess whether it would be safe to adopt a policy of processing only suspicious gallbladders without compromising patient management and outcome. Methods: A retrospective analysis of all cholecystectomies performed between 1995 and 1999 was conducted using computerised histopathology records and patient notes. The histopathology department has a standardised procedure for the evaluation of cholecystectomy specimens and all gallbladders had been processed in this manner. Results: 1308 patients had undergone cholecystectomy (mean 262/ year). All specimens had been sent for histology: 1249 of the specimens showed chronic cholecystitis, 38 acute cholecystitis or empyema and 16 were removed as part of another procedure. In five gallbladders there was evidence of primary carcinoma. In all cases the gallbladder was opened at the time of surgery (as commented upon in the operation notes) and all showed macroscopic evidence suggestive of carcinoma. Pre-operative ultrasound scanning identified probable carcinoma in three of the five cases. Conclusions: All cases of gallbladder carcinoma were diagnosed pre-operatively or intra-operatively and a histological diagnosis did not alter the management or outcome of any of these patients. Selective histopathology of the gallbladder is safe and may be a more measured approach saving histolopathology departments time and money

INTRODUCTION
Recent events and changes in NHS practice have led to an increase in workload pressures on consultant histopathologists. Sub-specialisation, increased clinical demand, more detailed analysis of specimens and minimum standards of reporting on difficult cases are the main causes rather than an absolute increase in histological requests.¹ Participation in clinical audit, quality assurance, continuing professional development and a need to standardise reporting of specimens have also put pressure on the service. The provision of adequate numbers of appropriately trained staff at all levels is also critical to the provision of pathology services and maintenance of high standards.² Consultant surgeons are frequently appointed by Trusts without a parallel increase in the number of histopathologists putting further pressure on an already stretched service.

Analysis of specimens that provide no advantage to the patient, surgeon or histopathologist would seem futile. Certain tissues may not require microscopic assessment and could be selectively analysed only if a macroscopic abnormality were detected saving pathology departments time and resources; cholecystectomy specimens may be one such tissue. In most hospitals, cholecystectomy specimens are routinely sent for histology regardless of whether or not there is any visible macroscopic abnormality. Our aim in this study, from a large district general hospital, was to assess whether or not it would be safe to adopt a policy of processing only those gallbladders (which on pre-operative imaging or on intra-operative findings) had features suggestive of cancer, without compromising patient management and outcome.

PATIENTS AND METHODS
A retrospective analysis of all cholecystectomies performed between 1995 and 1999 at Blackpool Victoria hospital was conducted. Computerised histopathology records and patient notes were studied and both were crossreferenced with the ICD10 coding system. The histopathology department has a standardised procedure for the evaluation of cholecystectomy specimens and all gallbladders had been processed in this way.

RESULTS
Over the five-year period 1308 patients had undergone cholecystectomy (mean 262/year). All specimens had been sent for histological assessment: 1249 of the specimens showed chronic cholecystitis, 38 acute cholecystitis or empyema and 16 were removed as part of another procedure. Primary gallbladder carcinoma (GBC) was demonstrated in five specimens (Table 1). In all cases the gallbladder was opened at the time of surgery (as commented upon in the operation notes) and all showed macroscopic evidence suggestive of GBC including raised or solid lesions, ulceration or carcinomatous deposits. Pre-operative ultrasound scanning identified probable GBC in three of the five cases.

DISCUSSION
Carcinoma of the gallbladder is reported to be the most frequent carcinoma of the extra-hepatic biliary tract, found in 2% of patients undergoing biliary surgery.³ Prognosis remains poor with a five year survival rate of less than 5%. The majority are adenocarcinomas but squamous, mixed or undifferentiated types also occur. Symptoms are often non-specific and the diagnosis often made at an advanced stage at operation for routine cholecystectomy.

Treatment remains controversial with only 10-30% of tumours resectable at presentation. Surgical resection of the gallbladder, resection of hepatic wedges and more extensive procedures carry significant morbidity and mortality with  no proven survival advantage.^4,5 Many authors have reported that outcome in patients with stage I GBC is good after cholecystectomy alone and that radical resection should only be contemplated in stage II-IV disease.^6,7,8 Chemotherapy confers no significant survival benefit and radiotherapy appears to have a role only in palliation of symptoms.

In this study, we found only five cases of GBC, all of which were diagnosed pre-operatively and / or intra-operatively; a histological diagnosis did not alter the management or outcome of any of these patients. Furthermore, if an early GBC had been missed on macroscopic examination, it would have been successfully treated by cholecystectomy alone and no further treatment would have been necessary.

The total time taken to process one gallbladder specimen in the histopathology department has been calculated to be 16 minutes. Processing 1308 would have taken one histopathologist approximately 350 hours over the five years (70 hours/ year). The cost to the NHS of processing one specimen of this size at this hospital is £10.40. This equates to a total cost of £13,600 for these specimens (£2,720/year).

Few studies have assessed the time and cost implications of routinely sending all specimens for histology. Taylor and Huang (1998) have suggested a more considered approach.⁹ A policy could be adopted whereby the gallbladder is opened at the time of surgery, the mucosa examined and any suspicious (polyps, nodules, ulcers, an indurated gallbladder wall or penetration into the liver bed) gallbladder sent for histolopathological assessment. The Royal College of Pathologists (RCPath) published “A recovery plan for histopathology” in 2001 to address some of the issues concerning consultant staffing levels in histopathology departments.¹¹ This stated that “the College should initiate a series of evidence-based multidisciplinary evaluations of investigations of doubtful clinical utility to identify those that make little or no contribution to patient care and welfare”. Six consultant histopathologists undertook a review of their own working practices. The group agreed several general points regarding the processing of specimens which included: (i) a gross inspection with a single histology section to act as a record, and for audit purposes, may well suffice for some tissue specimens and (ii) clinicians appear to feel that an examination is not complete without a biopsy and a change in this clinical behaviour pattern will only be achieved by good audit evidence and local discussion with clinical teams. The report goes on to say that gallbladder specimens should be examined as significant pathology may be present with normal gross morphology.

The RCPath have also recommended that for a district general hospital, 4000 histopathology specimens per fulltime consultant per year is a practical number, as many specimens now require considerably more investigation than previously. They concede, however, that many departments deal with considerably more than this number.² An alteration in practice, whereby some specimens are not analysed unless macroscopically abnormal, where less “blocks” are taken from some specimens and where analysis is performed by biomedical scientists, may reduce the workload on histopathologists without compromising patient welfare.¹²

Indeed, in our study although we found no cases of early GBC, there is evidence from other studies to show that early GBC is best treated by cholecystectomy alone. Therefore, an unidentified early GBC would have been treated according to current standards and a histological diagnosis would not have altered patient treatment or outcome.

We do not deny that tests do not have to be positive to be beneficial and that negative results may be comforting to both patient and surgeon. The argument that all specimens should be processed because of the current medicolegal climate is also not a valid justification for “routine” histopathology - should we not be practising evidence-based medicine? We expect, however, that it will be necessary for surgeons, histopathologists and the Royal Colleges to agree on guidelines and protocols based on evidence from trials before such a policy of selective histopathology of gallbladder specimens can be implemented without redress.

CONCLUSIONS
Carcinoma of the gallbladder can be diagnosed with a combination of pre-operative ultrasound and intraoperative examination in most if not all cases. However, any early lesions “missed” by these methods would have been successfully treated by the cholecystectomy alone. Any patient with a suspicion of GBC, either pre- operatively or intra-operatively, should have the gallbladder sent for histology. A more selective approach to gallbladder histology would be more evidence-based and save histopathology departments unnecessary processing time, reporting time and valuable economic resources.

REFERENCES
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11. Underwood JCE. A recovery plan for histopathology. R C Path Bulletin 2001; 113: 12-14
12. Draft guidelines for the involvement of biomedical scientists in the dissection of specimens and selection of tissues. Report of a working party of The Royal College of Pathologists. London: Royal College of Pathologists, 2001.

Copyright: 17 February 2003