Predicting the prognostic factors to determine which procedure is the frrst either laparoscopy or ERCP in cholecystocholedocholithiasis

Predicting the prognostic factors to determine which procedure is the frrst either laparoscopy or ERCP in cholecystocholedocholithiasis

Awny A El-Zeftawy,MD#; Mohamed Al-Sayed,MD#;

Mansour M Morsy,MD*; Wael Shelfa,MD*

Department of General Surgery, Zagazig University.

Abstract

Background: The obvious goal of therapy in choledocholithiasis is to achieve ductal clearance with the fewest number of interventions, lowest cost and least morbidity. Until now no agreement about the ideal approach for management of stone common bile duct associated with gall bladder stone that may be achieved cu"ently according to a two-step-protocol (endoscopic sphincterotomy associated with laparoscopic cholecystectomy) or by a one-step laparoscopic procedure, including exploration of the CBD and cholecystectomy. The aim of this study is to evaluate both procedures and to determine the prognostic factors to prefer either of both.

Patients and methods: A prospective study included 44 patients treated for gallbladderICED stones in the period from October 2008 through December 2010 were divided into two groups, group A treated  with Lap first (by the first two authors#) and group B treated with ERCP first (was treated with the second two authors*).

The obtained results were compared with each other; the mean follow-up period was 6±1.3 months (range; 4-8 months).

Results: Total operative time was shorter for LC+LCBDE. The incidence of postoperative complications such as cholangitis  and pancreatitis are common in group B versus group A. Regarding the success rate and conversion rate; in group A two cases were converted to open surgery and one case to ERCP, versus two cases in group B (due to difficult cannulation, so they were converted to lap surgery) and one case due to impacted large stone more than 2 em that was converted  to open surgery. Late complications are bile leakage in group A, versus three  cases  in group  B in the  form  of  mild  pancreatitis and  cholangitis and  bleeding.

Conclusions: LC+LCBDE and ERCPIS+LC were highly effective in detecting and removing common bile duct stones and were equivalent in overall cost and patient acceptance. LF approach to gallbladder/CBD stones is safe and feasible. It may allow the majority of surgeons to avoid excessively difficult/dangerous surgical procedures as well as unnecessary ERCPs in most cases. Key words: CBD stones, endoscopy, ERCP.

Introduction:

More than 10% of the patients with gall bladder stones have synchronous common bile duct  stone.IThese, according to European Association for Endoscopic  Surgery (EAES) guidelines,2 should be treated even if asymptomatic. Bile duct stones are found in

7-20 % of patients with symptomatic gallstones. The  presence of common bile  duct  stones

significantly increases the morbidity, mortality, and  costs of  patients with   gallstones.!

Traditional surgical  treatment comprises intraoperative cholangiography to detect the presence of  bile  duct  calculi  followed by choledocholithotomy and T-tube placement. For many years this procedure offered effective therapy and was associated with a morbidity rate of 10-15%,  a mortality  rate of<1% (in

patients under 65 years) and a retained stone rate below 6%.2,3 It was reported that one stage operations  have some benefits, as compared to two stage operations. Morbidity after one­ stage operations was only 7.5% (2 times lower).

Postponing laparoscopic cholecystectomy, after ERCP, makes it difficult to be performed due to the possibility of adhesions at the area of CalotAfs triangle, this is in additional to the risk of second time anesthesia.4 There is now equipoise as to whether  surgical treatment alone (open or laparoscopic) or a combined endoscopic-surgical approach is the  more effective treatment strategy for the management of  choledocholithiasis in association with gallbladder stones.Furthermore, if endoscopic treatment is used in conjunction with surgery, it better to operate before or after endoscopy? Several randomized controlled trials have been published in an attempt to answer one or other, or both, of the above questions.

In   1980s, endoscopic retrograde cholangiopancreatography (ERCP) followed by sphincterotomy has become the most widely used method for imaging and treating CBD stones5,6, but recently and in large series ERCP had carried some morbidity  (5 to 9.8%) and mortality rate (0.3  to 2.3%),7-10 due to pancreatitis, duodenal perforation and bleeding procedures. The purpose  of our paper is to present our  experience with  laparoscopic cholecystectomy LC+LCBDE versus ERCP/S+LC (endoscopic sphincterotomy and common duct stone extraction with laparoscopic cholecystectomy).

Patients and methods:

This  is a prospective study  that  was performed to  determine the  postoperative outcome of patients treated for CBD stones from January 2009 to December 2010, in two patients groups each with 22 patients. Group A was treated with laparoscopy first and group B treated with endoscopy first. No significant difference was present between both groups regarding age, sex, associated  diseases  and parameters of inclusion criteria. Inclusion criteria: Age>18 years,  biliary-type pain, ultrasonographic demonstration of cholecystolithiasis, platelet count>100,000 per mm3 and  prothrombin time<3 seconds of

control, American Society of Anesthesiology

{ASA) risk grade I or II, common  bile duct diameter greater than 6 mm by ultrasound or computed tomography (CT) scan, intrahepatic duct dilation as determined by ultrasound  or CT scan, serum bilirubin greater than 2mg/dl, alkaline phosphatase and/or lipase more than

1.5 times upper limit of normal within 48 hours of intended  first. Exclusion  criteria: History of bleeding disorders, platelet count<IOO,OOO per mm3 and/or prothrombin time>3 seconds over  control, uremia as evidenced by a creatinine>3 mg/dl and/or blood urea nitrogen>50 mg/dl,  ultrasonography or CT evidence  of cirrhosis, liver mass or abscess, or  periampullary neoplasm. All  patients received preoperative intramuscular injection of vitamin K {Konakion®) 10 mg twice daily for 3 days for patients with slightly prolonged PT, and prophylactic broad spectrum antibiotic cefobid® (cefoperazone  sodium)  as it covers common biliary flora.

The procedure:

Lap first  Group  A: LC + LCBDE  were performed  in a routine. Cholangiograms by antegrade contrast flushing through the cystic duct  Figures(1,2,3). During  intraoperative cholangiography  we used the iv grey cannula sheath instead of  a fifth trocar  through which we passed the cholangiographic catheter and this made the patient avoid unnecessary fifth trocar in case of negative IOC, and we used the (3Fr)  Fogarty  catheter after  cutting its balloon (this made its guide wire 2-3 em longer than the catheter itself) as a cholangiocatheter and it was more helpful as its  lumen resisted occlusion on exerting external pressure also it has a guide wire. When stones were detected or suspected by cholangiography, trans-cystic exploration was  undertaken by  balloon  or basket. A  completion cholangiogram was obtained to confirm that all stones were removed. Once the LCBDE was completed, the cystic duct was ligated and the gallbladder removed or choledochotomy may be done and closed  over T tube or with primary  closure Figures(4,5).

ERCP first group B: Patients randomized to ERCP/S + LC were scheduled to undergo the endoscopic  procedure  using fluoroscopy

(OEC Diasonics 9400) in the endoscopy suite under moderate sedation (principally intravenous midazolam and meperidine) prior to the intended laparoscopy. If choledocholithiasis was detected or suspected at the time of ERCP, a sphincterotomy was undertaken so that gallstones could be extracted using a balloon  catheter  or retrieval  basket. Small bowel gas was aspirated endoscopically as much as possible at the conclusion  of the ERCP. The laparoscopic cholecystectomy was subsequently done Figures(4,5).

Results:

The  most  common complaint was right

upper quadrant (RUQ) and biliary pain which was found in 18 patients (81.8%) in Lap first group, 14 patients (63.4%) in ERCP first group, followed by jaundice in 11 patients in the 1st group (50%) and in 13 patients (59.4%) in the

2nd  group  Table(l).   Abdominal

ultrasonography (U/S) was done for all patients in this study. It was able to reveal chronic calcular cholecystitis in all patients. Dilatation of CBD with stone/stones inside was detectable in 33 patients only (75%). The remaining 11 cases were subjected to MRCP to ensure the diagnosis of calcular obstructive jaundice Figures(6,7,8).

Table (1): Preoperative patient's characteristics.

Table (1): Postoperative patient's characteristics.

The total operative time was shorter for LC+LCBDE. No significant difference was present between both groups regarding the morbidity rate. Two cases were converted to open surgery and one to ERCP in group A versus two cases in group B with difficult

cannulation  which were converted to open surgery and one case due to impacted large stone more than 1 em. Late complications occurred in group A in the form of bile leakage in one patient, versus 3 in group B; mild pancreatitis, cholangitis and  bleeding.

Figure (1): Laparoscopic intra-operative cholangiogram.

Figure (2): Intra-operative cholangiogram  through the cystic duct.

Figure (3): Skeletonization of

CBD.

Figure (7): ERCP showing 2 stones in CBD.

Figure (8): Endoscopic stone     Figure (9): ERCP and stone extraction by Dormia basket.                                                   extraction.

The postoperative hospital stay was shorter for the Lap first group 2 to 11 (mean SD, .5) days vs 2 to 15 [5.3] days in ERCP first; P>0.05. There was no significant difference regarding the conversion rate, three cases were converted to the  other  procedure or open surgery in both groups.

The postoperative hospital stay was shorter

for the Lap first group (2 to 11 days with SD [3.5] days) vs 2 to 15 [5.3] days in ERCP frrst; P> 0.05. There was no significant difference regarding the conversion rate; three cases were converted to the  other  procedure or open surgery in both groups.

The total  cost  for  LC+LCBDE was not

significantly different than those for ERCP/S+LC; 1223 to 4423 [2637±12.3] in Lap first group vs 2443 to 4139 [2948±32.4] in ERCP frrst group.

There were no significant differences in both groups regarding the conversion rate and operative  complications 3/22 (13.5%). The conversion  includes one case in whom CBD clearance could not  be  achieved due  to impacted large stone in its lower part and this

cases was completed with ERCP, and one case was converted to open approach due to sever adhesions in the Callot's triangle and bleeding, the third case was operated on later after one week  due to  bile  leakage in patients with primary  closure  of the CBD. In group  B, 3 cases had failed procedure two of them due to failed cannulation and were converted to Lap. The third case was converted to open surgery also  due to impacted large  stone  (15 mm).

Regarding the  late postoperative complications wehad one case (4.5%) in group A with persistent bile leak versus three cases in group B (13.5%); one pancreatitis, one case with cholangitis and one case with bleeding. All were  controlled conservatively. The procedure time ranged from 155 to 175 minutes with a mean of 165±1.1 minutes in group A versus 195 minutes with a mean of 180±2.1 minutes in group B.

Discussion:

The current options available for the management of choledocholithiasis at the time of LC, include pre-operative ERCP and ES,

intra-operative ERCP, post-operative  ERCP, laparoscopic transcystic common bile duct exploration  (LTCCBDE), laparoscopic choledochotomy and LCBDE and open bile duct exploration},?

The sex and age distribution in our study is in agreement with many studies which found that the gallstones and CBD stones were more common in females and fifth to sixth decades. The most common complaint in our patients was right upper quadrant pain (RUQP) (72.3%) and was followed by jaundice (54.5%).4,5 These findings were in some agreement with several studies.4,5

MRCP was used successfully to diagnose CBD stones in 11 patients who had equivocal results  on transabdominal ultrasonography, these findings were also reported by several studies which  found that MRCP  has an excellent overall sensitivity of 95%  and a specificity of 97% for demonstrating CBD stones with no significant differences between it and EUS (Endoscopic IDtrasonography)  in the detection ofCBD stones.6,7,8

Whether to start with ERCP or LC is a matter of debate. We preferred  to start with Lap and go on for laparoscopic exploration of the CBD and stone extraction that if failed we will go to the other procedures which may be ERCP or open procedure to choose either of both, depended on the adhesions around Callot's area and the diameter  of the stone.

Endoscopic stone retrieval via the ampulla was done after an adequate  sphincterotomy (we did not use balloon dilatation) for fear of post ERCP pancreatitis. Other studies denoted that balloon dilatation of the papilla can be an alternative to biliary sphincterotomy, and has been advocated in patients with coagulopathy or cirrhosis, where risk of post sphincterotomy haemorrhage is increased. However, risk of severe  PEP  is  increased in comparison to bleeding, and  in  the  majority of  patients undergoing stone extraction  balloon dilation should be avoided.8,9

We used balloon for extraction of common bile duct stones that were <I  em in diameter (to avoid stone impaction). Also we used the basket  for extraction of larger  stones.  This coupled with what was stated by some authors.

Regarding the conversion rate for the other

procedure or for open surgery we had only three cases converted in group A (13.5%) who were converted to open procedure; one due to impacted stone that failed to be extracted and the other  case   due to bleeding and severe adhesions versus three cases (13.5%) in group B two  cases  were  converted due  to  failed cannulation and were converted  to Lap, the third case was converted  to open procedure due to impacted stone in the lower part of the common bile duct with no significant difference with an overall success rate 87.5% ERCP/S+LC versus 91% in Lap first group. However other studies denoted that the overall success rate of ERCP/S+LC in experienced hands  is well established at about 95%.10

Postoperative complications occurred  in three patients (13.5%) and were  minor complications  in the form of minimal biliary leakage and were  managed conservatively except  one that needed  conversion to open procedure and mortality was zero. This was in agreement with several studies which reported morbidity rate of 4-16% and a mortality rate of around 0%-2%.9,10 Some studies reported

5.55% morbidity and mortality rate of zero, this  was  in  agreement with  our  study,7.11

The postoperative  cholangitis occurred in group B  in form oflow-grade fever, nausea, vomiting, epigastric discomfort, diarrhea and one case with pancreatitis versus 0 patients in group A,  most  probably due  to  damaged sphincter in group B versus intact sphincter in group A, whereas in other studies symptoms of low-grade cholangitis were  detected in

20.36% patients.9 -13  Hong et al., stated that

EST may cause Oddi's sphincter dysfunction and still is controversial whether  it leads to stone recurrence and biliary carcinoma caused by permanent  duodenal  and pancreatic  fluid reflux.14

In early cases time of the procedures was longer than in late cases. Our procedure mean time was 165±1.1 versus180±2.1minutes in both groups respectively.This was in agreement with the study carried out by others which denoted mean operative time of 182 minutes.14

This was in disagreement  with another study which denoted mean operative time of 140.32 minutes.15

Postoperative lengths of hospital stay ranged

from 2 to 11 days (mean 3.5 days) versus 2-

15 (5.3) inboth groups respectively. This coupe with what was found by Stanley et al., in their study in which the mean postoperative period was 4.1 days.I4,15

In  our  study, there  was  no  significant difference in hospital charges in  both procedures. This was incontrast with the study carried out by Hawashi  et al which denoted more charges  for the procedure in group B

versus A_l5,16

During intraoperative cholangiography we faced some difficulties in cystic duct cannulation in two cases and we overcome this by using the guide wire of our Fogarty catheter. Other  difficulty was in interpreting the cholangiogram  in relation to the appearance of round lucencies (air bubbles vs small stones). To overcome  this we slowly injected  2 to 3 mL of contrast under constant fluoroscopic control then we withdrew the plunger to create a vacuum. We repeated this maneuver twice and observed  the motion  and appearance  of the lucency. Bubbles move in synchrony with the column of contrast. Stones tend to adhere to the wall of the duct and do not move. This problem was faced and solved in the same way by Stanley et al, at 2010.17

The procedures were completed in 20 cases (91%)  with  two  cases  converted to  open surgery, one was due to severe  adhesions in Calot's triangle and one case because of stone removal failure (stone removed later on by ERCP). Similar study carried out by Hong al, denoted rate  of 80%  to 99%.18,19 In other studies success rate  of  80%  to  95%  were

reported.19,20

Ten patients were subjected to choledochotomy in whom CBD was closed primarily in 7 cases and the other 3 cases were drained by T- tube. Biliary leakage occurred postoperatively in one patient  of the seven cases who were closed primary. Many studies comparing primary closure versus  T-tube drainage suggest similar rates of complications with shorter operating times and a trend toward shorter  hospital  stays with primary  closure. But some authors like Roush et al and Soe et al believed that T-tube drainage is preferred for the safety of the patient.18-20

In this study we used the choledochoscope

for 3 patients  and it was helpful  to confirm bile duct clearance and to visualize the proximal portion of the CBD but in these cases the operating time was a little longer.In the other five cases choledochoscope was replaced (due to  some technical problems in  the choledochoscope) by fluoroscopic guidance

and confirmatory roc. This was in agreement

with Rhodes et al who denoted nearly similar efficacy between fluoroscopic guidance.21,22

This was in contrary to  Sgourakis  et al who reported that the  use  of  a flexible choledochoscope is preferable !fluoroscopic guidance.22

Conclusions:

Both ERCP/S+LC and LC+LCBDE were highly effective detecting and removing common bile duct stones and were equivalent patient acceptance. However,  the overall of hospitalization was shorter and physician fees lower LC+LCBDE.

References:

1- Martin DJ, Vernon DR. Toouli J: Surgical versus endoscopic  treatment  of bile duct stones. Cochrane Database Syst Rev 2006; (2): CD003327.

2- Morino M, Baracchi F, Miglietta C, Furlan

N, Ragona R, Garbarini  A: Preoperative endoscopic sphincterotomy versus laparoendoscopic rendezvous in patients with gallbladder and bile duct stones.Ann Surg 2006; 244: 889-893.

3- Clayton ES, ConnorS, Alexakis N, Leandros

E: Meta-analysis of endoscopy and surgery versus surgery alone for common bile duct stones  with the gallbladder in situ. Br J Surg 2006; 93:1185-1191.

4- Barwood  NT, Valinsky LJ, Hobbs  MS, Fletcher DR, Knuiman  MW, Ridout SC: Changing methods of imaging the common bile        duct   in    the  laparoscopic cholecystectomy era in Western Australia: Implications for surgical practice.Ann Surg

2002; 235: 41-50.

5- Ghazi A, McSherry CK: Endoscopic retrograde cholangiopancreatography and sphincterotomy. Ann Surg 1984; 199: 21-

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6- Rhodes  M, Sussman  L, Cohen  L, Lewis