Operative treatment is no safer than endoscopic sphincterotomy in the young patient with bile duct stones

HPB 1999

Volume I, Number 2, 5 I-55

Review

Operative treatment is no safer than endoscopic sphincterotomy in the young patient with bile duct stones NI McDougall I and TCK Tham 2 'Antrim & Whiteabbey Hospitals, Northern Ireland; 2Ulster Hospital Dundonald, Belfast, Northern Ireland, UK

Abstract

morbidity but as sphincterotomy is much more widely

The rapid expansion of laparoscopic cholecystectomy has

available it will probably remain the treatment of choice in

led to debate regarding the optimal method of dealing with

many centres.

concomitant stones in the common bile duct (CBO), par-

Patients requiring a cholecystectomy should only undergo

ticularly in younger patients. The choice lies between four

a pre-operative ERCP if they fulfil strict criteria which have

techniques. ERCP and sphincterotomy is the endoscopic

been shown to reduce the frequency of unnecessary pro-

treatment of choice and should result in a complication

cedures. Any CBO stones can be removed by sphinctero-

rate of 5% or less with similar long term morbidity to

tomy before proceeding to laparoscopic cholecystectomy.

open BVO operation. Endoscopic balloon dilation of the

Those whose intra-operative cholangiogram shows a CBO

papilla is a technique which shows much promise but

stone should have a post-operative ERCP or alternatively

requires further evaluation in randomised trials. Open sur-

LCBOE in centres where sufficient expertise exists. Time

gical exploration of the CBO was the treatment of choice

will tell if LCBOE can surpass the standards currently being

prior to the advent of endoscopic sphincterotomy.

set by endoscopic sphincterotomy.

However, it is now less frequently performed due to the edvent of laparoscopic techniques. Laparoscopic CBO

Keywords

exploration (LCBOE) is effective in over 90% of selected

ERCp, sphincterotomy, common bile duct surgery, laparo-

cases but is not widely available. Initial studies suggest that

scopic cholecystectomy, gallstones, choledocholithiasis, bal-

LCBOE and sphincterotomy have comparable efficacy and

loon dilatation of sphincter, complications.

Introduction Laparoscopic cholecystectomy is n ow the standard treatment for symptomatic gallstones. The advantages of a

This policy h as led to concerns over the safety and longterm consequences of sphincterotomy in younger patients. The morbidity and mortality rates of sphincterotomy

laparoscop ic procedure over open cholecystectomy -

are not related to age [2,3] whereas the risk of open CBD

reduced pain, rapid discharge from hospital and return to

operations increases with age [4] . It h as been suggested that

normal activities, improved cosmesis [1]- are so consider-

open operation may be as safe as sphincterotomy in yo unger

able that, if local expertise is available, it is the procedure

patients (age < 60 years), without the potential long-term

of choice. Given this preference for a minimally invasive

complications of the latter [5] . To determine which option

approach, the tendency in recent years has been to perform

is best for treating a young patient with CBD stones, the

endoscopic sphincterotomy, in combination with laparo-

therapeutic alternatives must be compared with regard to

scopic cholecystectomy, to manage patients with tones in

the relative risk of complications and the long-term out-

both the gall-bladder and the common bile duct (CBD).

come. Four main options for CBD stone extraction are

Correspondence to: TCK Thorn, Ulster HOSPIW" Duneondd. Belfast BTl6 ORH, Northern Ireland, UK

© 1999 Isis Medical Media Ltd.

51

NI McDougall and TCK Tham available: endoscopic sphincterotomy; endoscopic balloon dilation of the papilla (EBDP); laparoscopic CBD exploration (LCBDE) at the time of laparoscopic cholecystectomy; and open surgical CBD exploration.

ERCP and sphincterotomy Following its inttoduction 25 years ago, endoscopic sphincterotomy has become the accepted method for removing CBD stones from elderly high-risk patients, causing appreciably fewer complications than open operation on the duct [6]. In addition, randomised trials have demonstrated th at endoscopic' sphincterotomy is the treatment of choice in acute cholangitis and gallstone-related pancreatitis [7-9] . Given the well-recognised complications - haemorrhage, cholangitis, pancreatitis, perforation and even death, not to mention the uncertainty regarding long-term sequelae - there has always been concern over performing sphincterotomy in younger patients. Nevertheless, the rapid expansion of lapatoscopic cholecystectomy has led to a marked increase in the number of young patients with CBD stones undergoing sphincterotomy. Cotton and colleagues recently suggested that traditionally-quoted complication rates for sphincterotomy (10% morbjdity, 1% mortality [4]) over-estimate the actual complication rate that can be expected in younger patients without co-morbidity. In a large multi-centre study of patients undergoing sphincterotomy for CBD stones, they reported an overall complication rate of 5.8% and a 0.2% mortality rate [3] . The subgroup of patients < 60 years old with CBD diameters < 9 mm had even fewer complications (4.2 %) and no deaths. This study was performed in expert centres and it remains to be seen if community-based endoscopists can achieve similar results. Another study by Freeman and co-workers reported an overall morbidity rate for all sphincterotomies of 9.8%, but the complication rate w~/only 4.9% in those whose indication for sphincterotomy was removal of CBD stones within 30 days of laparoscopic cholecystectomy [9]. A third recently-published study from Italy reported a morbidity rate of 5.4% and mortality rate of 0.49% among 1827 therapeutic ERCPs, although less than two-thirds of these procedures were for CBD stones [10] . These studies suggest that an early complication rate of :::; 5% in younger patients undergoing sphincterotomy for CBD stones is probably the standard against which operative treatment (and other ERCP centres) should be compared.

52

There are concerns regarding the late complications of sphincterotomy [5]. phincter function can be permanently 10 t, resulting in biliary reflux of duodenal chyme and bacterobilia [11]. In a long-term follow-up study of young patients who underwent sphincterotomy for CBD stones, Bergman and colleagues, found recurrent biliary problems in 24%, mostly in the form of recurrent stones which could be dealt with endoscopically [12]. However, four other long-term fo llow-up studies in younger patients (upper age limits 50-70 years) reported much lower recurrent biliary problem rates of 6-1 0% [13-16]. It is important to note that not all these recurrent problems are sphincterotomyrelated and that the commonest problems (recurrent stones, sphincter stenosis and cholangitis) can usually be managed endoscopically. A recent review of the literature including these studies concluded that the long-term results of endoscopic sphincterotomy seem comparable to those of operation [4].

ERCP and ESOP EBDP was introduced as an alternative to sphincterotomy that allowed stone extraction without the risk of bleeding or permanent damage to the sphincter. Initial reports with EBDP were encouraging, suggesting that small stones « 8-12 mm) could be safely extracted in 82-100% of selected cases [17-19]. A recent large study from Japan reported 99% success with the technique, although mechanical lithotripsy was needed in 35% [20]. The incidence of pancreatitis in these reports was 0-7%. One review suggested that in those patients with CBD stones < 10 mm in diameter and fewer than 3 stones, EBDP is nearly always successful, without sphincterotomy or mechanical lithotripsy [21]. However, results from recent randomised trials may give cause for concern. The Amsterdam group compared EBDP with sphincterotomy in 202 patients with CBD stones [22]. They found the two techniques to have similar efficacy and complication rates, but EBDP was associated with a greater need for mechanical lithotripsy and caused a single fatality, due to retroperitoneal perforation. In another multi-centre randomised study of 177 patients from the USA, DiSario and co-workers also found similar efficacy for sphincterotomy and EBDP in removing CBD stones, but EBDP showed a trend towards a higher complication rate (12% versus 1%, P = 0.06) and caused two deaths (3%) due to pancreatitis [23] . The long-term sequelae of balloon dilation, if any, are unknown. EBDP probably has a role in selected cases, but

Operative treatment is no safer than endoscopic sphincterotomy in the young patient with bile duct stones it wou ld seem prudent to restrict its use in C BO-stone extraction to further rando mised trials, unt il the complication rates and long-term outcomes are more clearly defined.

The surgical alternative For many years, open surgical exploration was the treatment of cho ice for patients with CBO stones. Moreaux reported a complication rate of 24.5% (mostly minor) and a mortality rate of 0.3% in a series of 579 consecutive patients treated with open surgical management of CBO stones [24]. Other studies within the past 10 years on open operation for CBO stones h ave reported procedure-related morbidity rates of 8-33%, mortality rates of 0-4% and residual stone rates < 10% [24]. Long- term fo llow-up studies have demonstrated that up to 36% of patients develop complications 5-10 years after CBO exp loration, although the complication rate is much lower if a drainage procedure is also performed [4] . These results seem fairly comparable with those of endoscopic sphincterotomy, but wide variat ions ex ist in surgical techniques and patient spectrum, making it difficult to extrapo late results. As laparoscopic cholecystectomy is now the treatment of choice for symptomatic ga llstones, surgical CBO exploration is less frequently performed. A lthough techniques have advanced conSiderably over the past 8 years [25], LCBOE is still not widely ava ilable and has never been compared in a randomised trial with open CBO exploration . Severa l series have reported that successful stone clearance can be achieved with LCBOE in > 90% of cases [26,2 7], although these are series in patients who have already been preselected as suitable for a laparoscop ic proced ure.

Comparisons of operation with endoscopic sphincterotomy Three prospective randomised studies have shown that a combination of endoscop ic sphincterotomy to clear the

studies have made such comparisons. Rhodes et al. compared laparoscop ic CBO exploration with postoperative ERCP in 80 patients found to have C BO stones on intraoperative cholangiography [32]. Both techniques had similar efficacy and morbidity, with a trend fo r the laparoscopic CBO exploration group to have a shorter hospital stay. C uschieri and co-workers [33] randomised 207 patients undergo ing laparoscop ic cholecystectomy who were suspected of harbouring CBO stones to either preoperative ERCP, with sphincterotomy if indicated, followed by laparoscopic cholecystectomy, or a single-stage procedure consisting of laparoscopic ch olecystectomy and laparoscopic CBO stone ex traction [31]. They concluded that bo th options had equivalent success rates (aro und 80% achieved stone clearance ), but the single-stage procedure resulted in a shorter hosp ital stay. However, they did not control the waiting period between ERCP and operation (which presumab ly resulted in most of the delay) and there was a higher con version rate to open operation in the Single-stage group. Furthermore, there were three postoperative deaths in the stud y group and no ERCP-related mortality.

Suggested strategy So what should clinicians do with a yo ung patient who h as stones in the CBO? T here is currently no ev idence that laparoscop ic CBO exploration is safer than endoscopic sphincterotomy. Efficacy, initial morbidi ty and mortality risks for the two options in a yo ung patient with CBO stones seem to be comparable. The choice of procedure must be greatly influenced by the ava ilability of loca l expertise. An ERCP service with endoscop ic sphincterotomy is curre ntly more widely ava ilable than laparoscopic CBO exp loration and , for that reason alon e, it will be the treatment of choice in many centres. Future randomised trials comparing sphincterotomy and LCBOE and increased availability of LCBOE may change this assertion . Having decided that ERCP is the preferred option, the question rema ins as to when ERCP should be performed. It

CBO, followed by open cholecystectomy, h as no advantage over open cholecystectomy with CBO explorat ion [28- 30]. A restrospective study comparing open CBO explorat ion with endoscopic sphincterotomy suggested that the latter

is unacceptab le to perform ERCP in all patients undergo ing laparoscopic cholecystectomy, as only - 5% will have CBO stones, resulting in 95% having an unnecessary ,proced ure

may have less morbidity [31]. However, since open cholecystectomy is no longer the treatment of choice for symptomatic gallstones, stud ies comparing laparoscop ic CBO

[25]. There is obviously a need for patient selection . When ERCP is performed before laparoscopic cholecystectomy in patients with suspected CBO stones (due to

exploration with endoscop ic sphincterotomy would be of greater relevance to present clinical practice. O nly two

abnormal liver function tests, jaundice, dilated bile ducts and/or stones on US or C T scan) the detection rate is low

53

Nt McDougall and TCK Tham

(27-50%); the largest series to date reported a pOSItive diagnostic yield of only 32% [34]. We have recently shown that, by applying stricter criteria and only performing ERCP in those with jaundice and/or a demonstrated stone, the positive predictive value increased to 56%; only 3% of patients with stones were missed and the need for preoperative ERCP fell by 50% [34] . Others have endorsed the use of these same stricter criteria [25] . We would suggest that currently the most appropriate strategy in young patients requiring cholecystectomy for gallstones is to perform a preoperative ERCP only in those with jaundice or radiological evidence of a CBD stone and to remove any stones by sphincterotomy. Following laparoscopic cholecystectomy, an ERCP should be performed in those whose intraoperative cholangiogram showed a CBD stone. Alternatively, intraoperative LCBDE could be performed in centres with sufficient expertise, as it has similar efficacy to postoperative ERCP. It remains to be seen whether or not LCBDE will surpass the standards now being set by endoscopic management of CBD stones with respect to immediate and long-term complications in young patients.

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