Primary common bile duct closure after open exploration for choledocholithiasis

Primary common bile duct closure after open exploration for choledocholithiasis

MagdyASorour, MD

CIT Surgery Unit, General Surgery Department, University of Alexandria, Egypt.

Background:   Choledocholithiasis is   the    second-most     common    complication    of cholecystolithiasis,  occurring in approximately  10-15% of patients. For choledocholithiasis, there are  two  methods   for CBD  exploration  to  extract  stones:  either  endoscopically,  by endoscopic retrograde cholangiopancreatography (ERCP) with or without sphincterotomy, or surgically, by an open or laparoscopic method  Open CBD exploration has been the principal treatment in many hospitals and is still considered the gold  standard  for the removal of CBD stones.   Following  common bile duct  (CBD) exploration  and stone removal,  the choice  for closure  of the incised  bile  duct lies  between  primary  closure and  T-tube drainage.  There are many  papers reported  by different authors,  which support the direct closure of the duct immediately after exploration. The aim ofthis study was to assess the clinical short-term results and benefits of primary closure of the common bile duct after open choledochotomy  for CBD calculi in a developing country like Egypt.

Methods: Between December 2010 and December 2013; 74 patients with a radiological evidence of common bile duct stones were admitted and treated at the Gastrointestinal Surgery Unit, Main Alexandria University Hospitalin whom the common bile duct diameter was equal to or larger than 8 mm. Those associated with distal CBD strictures, multiple intrahepatic calculi, or malignancy were excluded  After approval of local ethics committees, all patients included in this study were informed well about the operative procedure and an informed written consent was obtained  from every patient before carrying  the procedure.   All patients'  data, surgical procedures, complications and  follow-up details were collected and analyzed

Results:  CBD exploration and stone removal  followed by primary closure was performed in all patients. The mean age of patients was 55.3 ±15.7 years {range, 37-75 years). Most of the patients presented  with biliary  colic (74%). Sixty-seven  patients  {90%) had  concomitant gallstones  as evident by preoperative abdominal ultrasound  The mean diameter of CBD was

12.3 ±3.2mm {range, 8-27mm). Themaximumnumberofstoneswas 14. The total complication

rate was 54% (4174) and included wound infection with delayed wound healing and bileleakage. One patient had a bile leakage that subsided on the third postoperative day. There was no post­ operative biliary obstruction,  residual  stones, cholangitis,  pancreatitis,  biliary peritonitis  or intra-abdominal collections. The mean postoperative hospital stay was 4.2 ± 1 days. There was no perioperativemortality. The mean durationof follow-up was 10.8 ± 3.2 months {range, 4-18 months). There was no recurrence of CBD stones or stricture of bile ducts observed during the follow up period and postoperative ultrasound findings were normal.

Conclusion: Primary closure of the CBD after open choledochotomy for choledocholithiasis

is safe, feasible and effective with shorter hospital stays and lower costs.

Key words:  Choledocholithiasis; cholelithiasis;  open choledochotomy;  common bile duct exploration; primary closure.

Introduction:

Choledocholithiasis  1s  the   second-most

common complication  of cholecystolithiasis, occurring   in   approximately             10-15   %   of

patients. 1-5    The    literature   suggests   that at least 3-10% of patients undergoing cholecystectomy  will   have   CBD   stones.5

Choledocholithiasis may lead to further complications, including biliary  colic, obstructive jaundice,  cholangitis, and pancreatitis. 3,4,6

For choledocholithiasis, there  are two methods  for   CBD   exploration  to   extract stones:  either  endoscopically, by endoscopic retrograde    cholangiopancreatography (ERCP)  with   or   without    sphincterotomy, or surgically, by an open or laparoscopic method.7

In the modem 'minimally invasive approach' era,  the  current  standard protocol for the  treatment of CBD  stones  is to  clear and drain the CBD by ERCP, followed by laparoscopic cholecystectomy. However; ERCP is less successful than  open surgery  in CBD stone clearance and is associated with a higher morbidity and mortality.8 If the patient has many and/or large stones, it can take considerable time for duct clearance, and this is associated  with  high  costs.9  There  is also an increased recurrence rate  of CBD  stones following endoscopic removai.lD

Laparoscopic common bile ductexploration

(LCBDE)  for   treating   choledocholithiasis is well known these days,9 but remains controversial. This procedure demands skills and  equipment, and is therefore used  by few surgeons.ll Moreover,  the superiority of this procedure for complete CBD stone  clearance has not yet been proven, which limits its applicability, despite  its short hospital admission.l2-15

Despite  these  advancements, many surgeons, especially in the developing world, still perform  open cholecystectomy with common bile  duct  (CBD)  exploration for choledocholithiasis due to lack oftraining as well as equipment.l6-18 Even in the developed world, there are places where these resources may not be available.  In fact, a recent survey from   the   rural   areas   of  United   States   of America showed  that  surgeons  had to resort to  open  biliary  surgical   procedures, due  to lack of equipment.l9.

Open    CBD   exploration  has   been   the

principal   treatment  in  many   hospitals   and is still  considered the  gold  standard for the removal  ofCBD stones.6 Following common bile      duct    (CBD)    exploration   and        stone removal, the choice for closure  of the incised bile  duct  lies  between   primary  closure   and T-tube     drainage.l,7,20,21      Choledochotomy followed by T-tube  drainage  is a traditional surgical   treatment  for   chloledocholithiasis for  most  of this  century_22,23. Although it is true  that  the  T-tube  has  been  used  and  has proven  to be a safe and effective  method  for postoperative biliary  decompression, it is not without   complications,  which   are   present in  up to 10%  of patients.l,20  Some  of these complications are serious,  such  as  bile leak, tract   infection  or  acute   renal  failure   from dehydration, particularly in elderly  patients. The  most  frequent of  these  is  bile  leakage resulting  from  T-tube  displacement or early removal   without   adequate  tract  formation, which   is  reported   to   occur   in   1-19%   of cases.l,ll,23-25      In   addition,     having          bile drainage  in place for weeks causes significant discomfort in patients  and delays their return

to work.20,21,26-28

Primary   closure  of  the  CBD  after exploration is not new. There are many papers reported  by different  authors,  which  support the  direct  closure   of  the  duct  immediately after  exploration.8,16,23,27,29-34 With the  help of a choledochoscope during  surgery,  direct

visualisation  of  the   CBD   is  possible   and retained  stones  are not a problem.

The  aim  of  this  study  was  to  assess  the clinical  short-term results  and benefits of primary  closure of the common bile duct after open choledochotomy for CBD calculi in a developing country  like Egypt.

Methods:

Between   December 2010  and  December

2013;    74   patients    with    a   radiologically confirmed    diagnosis          of         common           bile duct   stones   were   admitted   and  treated   at the          Gastrointestinal   Surgery    Unit,             Main Alexandria University Hospital.  Only patients with  CBD  diameter equal  to  or larger  than

8 mm  were  included;  those  with  associated distal  CBD  strictures, multiple   intrahepatic

calculi, severe pancreabtls, suppurative cholangitis   or  malignancy   were  excluded. After  approval  of  local  ethics  committees of  both  the  General   Surgery  Department and the Alexandria Faculty of Medicine, all patients included in the study were informed well about the operative procedure and an informed written consent was obtained from every patient before carrying the procedure.

All       patients       were       subjected      to

complete history taking, thorough clinical examination,    routine    laboratory    studies, liver function tests, liver enzymes, and abdominal ultrasonography. Whenever indicated; MRI with magnetic resonance cholangiopancreatography        (MRCP) Figure (1),    or   multi-slice    CT    (MSCT) abdomen was performed.

All  patients  were  operated   upon  under

general anesthesia. Prophylactic intra-venous antibiotic  (a  third  generation  cephalosporin and metronidazole)  was given to all patients at the  time  of  induction  of anesthesia  and was  continued  postoperatively  for  at  least two days. Prophylactic low molecular weight heparin   was   given  to   all  obese   patients and those at high risk and was continued postoperatively  during the period of hospital stay.

A  right  subcostal  incision  was  used  to

provide   exposure   of  the  CBD.  The  first step  was  cholecystectomy,   unless  the  gall bladder had already been removed, followed by  common  bile  duct  exploration  through a  supraduodenal   vertical  incision  between stay  sutures  Figure (2).  Stones  were  taken out, followed  by generous  saline  irrigation in the usual manner to ensure patency. A 5-8

Fr infant feeding tube was used for irrigation

to allow stones to float up alongside to be extruded at the choledochotomy.  Passage of the tube through the ampulla(ifno obstruction was present) was signaled by free flow of irrigant  to  the  duodenum   with  no  return through the choledochotomy.  In most  cases the CBD was cleared using this technique.  If however, a stone at the distal end could not be disimpacted, atransduodenal sphincteroplasty was  done and  patients  were excluded  from the  study.  Adequate  clearance  of  the  duct

was confirmed with a choledochoscope.  Then primary closure of the CBD was performed using interrupted  absorbable sutures  (Vicryl

4/0,  Ethicon).   Suture  closure  was  carried

out   delicately   to   avoid  tearing   the   duct wall. Transcystic intraoperative completion cholangiogram  was  routinely  performed  to rule  out  the  possibility  of  retained  stones or   distal   stricture.   The   diameter   of   the CBD was measured  on cholangiography during   the   operations.   Having   excluded from  the  study, some  patients  were  treated by choledochoenterostomy when their intraoperative       cholangiogram        showed distal stricture Figure (3). At the end of the procedure, an 18-20  Fr drain was placed in the sub-hepatic  space  and  was kept  in situ in all patients for two days postoperatively. Patients were discharged after laboratory findings were normal and no drains were required.

All   patients'    data,   operative   findings,

hospital stay, postoperative morbidity and follow up details were recorded and analyzed.

Biliary leakage was defined as any yellow bile-like fluid coming out of the sub hepatic drain or after the removal of the drain, aspiration of yellow coloured bile-like fluid under ultrasound guidance from sub hepatic peritoneal space (300mL).

Data     were     presented     with     numbers,

percentage, arithmetic mean (X) and standard deviation (SD) and were analyzed with SPSS (version 16) statistical software. P values less than 0.05 were considered to be statistically significant.

Results:

From December  2010 through  December

2013, 74 patients (26 males and 48 females) with a radiologically  confirmed CBD stones were operated upon in the Gastrointestinal Surgery Unit, Main Alexandria University Hospital.

All   74   patients   were   diagnosed   with

preoperative ultrasound. Magnetic resonance cholangiopancreatography (MRCP) and Computed tomography (CT) scans were performed preoperatively in 17 and 5 cases, respectively.

Twelve patients had previously undergone cholecystectomy  (open in eight and laparoscopic in four patients). Seven patients underwent  other  gastrointestinal  tract surgenes.

Seventeen   patients   refused  to   undergo

preoperative   ERCP  for  stone  retrieval  for fear  of  its  complications.   Twelve  patients underwent   preoperative   ERCP  that  failed to   extract   stones.   Two  patients  were  not candidate  for ERCP due to alteration  of the GIT  from  previous  surgery.  The  remaining

43 patients with multiple and large stones underwent  surgery  without  preoperative ERCP as it was expected to fail.

The   mean   age   of   patients   was   55.3

±15.7 years (range, 37-75 years). Patients' demographic  data,  preoperative  parameters and clinical presentation are listed in Table (1). Most  of the  patients  presented  with  biliary colic (74%). Other clinical presentations were obstructive  jaundice, acute cholecystitis,  and cholangitis.   All   patients   with   cholangitis were stabilized  by antibiotic  therapy  before the operation. Out of 74 patients, 15 patients had co-morbidities like diabetes mellitus and hypertension.

Eighty-eight   percent   of   surgeries   (65

patients)  were  done  on  elective  basis  and

12%  (9  patients)   on  an  emergency   basis. Sixty-seven patients (90%) had concomitant gallstones as evident by preoperative abdominal ultrasound. CBD exploration and stone  removal  followed  by primary  closure was performed in all patients. Preoperative abdominal ultrasound showed the size ofCBD and number of CBD stones, which was then confirmed during the operation. The mean diameter of CBD was 12.3 ±3.2 mm (range,

8-27mm).  The  maximum  number  of stones was  14.  None  of  the  patients  had  residual stones on intraoperative cholangiography Table (2).

Seventy patients did not suffer any complication.   The  total   complication   rate was  5.4%  (4/74)  and  included  wound infection    with    delayed    wound    healing and   bile   leakage.   All   wound   infections were successfully treated by appropriate antibiotics  with removal  of few stitches for

proper drainage and daily dressings. One patient had a bile leakage that subsided on the third  postoperative  day. There was no post­ operative biliary obstruction, residual stones, cholangitis,   pancreatitis,   biliary   peritonitis or intra-abdominal collections. The mean postoperative  hospital stay was 4.2 ±1 days (range, 3-7 days). There was no perioperative mortality.

The mean duration of follow-up was 10.8

±3.2 months (median, 12months; range, 4-18 months). There was no recurrence of CBD stones  or  stricture  of  bile  ducts  observed during the follow up period and postoperative ultrasound findings were normal.

Discussion:

Symptomatic gallstone disease is a very common indication for abdominal surgery.35

Before the laparoscopic era, cholecystectomy and CBD stones were removed in a single procedure. This approach has been effective with  morbidity   below   15%  and  mortality below  1% in a patient up to 65 years old.36

In the era of minimally  invasive procedures,

open    laparotomy    for    CBD    exploration may still be the choice in some hospitals  in developing countries.

In this  study,  all patients  underwent primary closure of the CBD after open choledochotomy for choledocholithiasis. Choledochoscopy and intraoperative cholangiography  were performed to ensure complete duct clearance.

Patients  with  CBD  diameter  less than  8

mm were not treated  by primary closure  of the CBD and were excluded from the study for fear  of CBD stenosis  and later stricture. Such  patients  were  treated   in  Alexandria Gastrointestinal    Surgery   Unit   by    either; (1)    preoperative        ERCP   and       endoscopic sphincterotomy followed by cholecystectomy, (2)      laparoscopic                 cholecystectomy                     and laparoscopic                CBD               exploration,37              (3) combined          laparoscopic    cholecystectomy and   intraoperative   ERCP   and  endoscopic sphincterotomy    (LC   + IO-ERCP   + ES).38

Those  associated  with  distal  stricture  were

also excluded and were treated by preoperative

ERCP    and    endoscopic    sphincterotomy;

Figure {1): MRCP showing marked dilatation of the CBD and intrahepatic biliary radicals with abrupt arrest at the mid-CBD showing positive meniscus sign, in  favor of a large CBD stone.

Figure {2): Open choledochotomy for CBD stone extraction  followed by primary closure.

Figure{3):lntraoperativecholangiogramshowingmarkeddilatationoftheCBDandintrahepatic biliary radicals, with smooth tapering distal CBD stricture, and a large CBD stone  with  free passage of the dye into the duodenum. This patient underwent choledochoduodenostomy and excluded  from the study.

Table 1: Patients' demographic data and preoperative parameters.

if failed, they were treated by open CBD exploration  and choledochoenterostomy. Those associated with multiple intrahepatic stones were treated in the same unit by Roux­ en-Y hepaticojejunostomy and subcutaneous access loop.

Patient's    choice,   failure   and   expected

failure   of   preoperative   ERCP   were   the main  indications  for  open  choledochotomy for   CBD   stones   in   this   study.   Despite the   great  benefit  of  ERCP,  it  may  cause

severe complications, such as pancreatltls, perforation of the duodenum or bile duct, cholangitis, bleeding, and cardiac and pulmonary  complications.39,40 Furthermore, if the  gastric tract has been modified by an operation, it may be difficult to reach Vater's papilla endoscopically. Neoptolemos et al41 reported that endoscopic stone retrieval combined with endoscopic sphincterotomy (ES)  has  its  place,  but  that  it  should  be reserved for a specific group of patients. It is

Table 2: Intraoperative parameters.

particularly beneficial in acute pancreabbs, severe cholangitis  and residual stones and in patients with significant  co-morbidities  who are not fit for surgery.

Two surgical procedures -laparoscopic and open laparotomy to remove CBD stones- are performed worldwide. Laparoscopic CBD exploration  with  laparoscopic  duct  closure is technically  challenging,  very complicated and should be carried out by skilled laparoscopic surgeons. Furthermore, not all types of CBD stones are indicated for this procedure. The clearance rate was reported to be 75%-99%.42-45 The recurrence  rate after laparoscopic  surgery  was 3.2%.15 Technical problems  requiring  repeated  surgeries  were also reported after LCBDE, and some of them were burden.ll  The above factors make many doctors hesitant to choose the laparoscopic approach.

In this study, a longitudinal incision for choledochotomy was chosen because of its easiness  with  no  risk  of stenosis.46  Khaled

et  al,44  in their  study,  preferred  transverse

choledochotomy  for CBD exploration.  They found  it easier and less likely to result in a duct  stricture  when  the  duct  was  slightly

dilated.  Decker  et  al47 performed  LCBDE via   transverse    choledochotomy    followed by primary duct closure in 100 cases and reported no biliary strictures postoperatively with a median follow-up of28 months, whilst Cai et al48 reported  no biliary  strictures amongst 137 longitudinal choledochotomies with primary closure at a median follow-up of 26 months.

The  presence   of  many  stones  was  not

a    contraindication    for    primary     closure. Thorough   clearance   of  CBD   stones   and dirty  bile  was  considered  to  be  the  most important,  but  not  the  number  of  stones. After  total  lithotomy,  the  choledochotomy line was closed primarily when smooth flow of  the  contrast  medium  to  the  duodenum was  shown  on  cholangiography.  Therefore, the function  of Vater's papilla was assessed just from  cholangiography.  For this  reason, preoperative    US,     transcystic     IOC,     and choledochoscopy  were used to evaluate  the number  and size  of stones in the  CBD  and to make  sure that  no calculus  was retained before suture. Severe pancreatitis, cholangitis, and a CBD diameter of less than 8mm were considered  as contraindications  for  primary

cholangitis  were first treated  conservatively, and  then  surgery  could  be  done  after  the patient had reached a non-inflammatory state.

T-tube drainage of the CBD after open exploration  has  been the  method  of choice for  many  years. 23,49,50  It is  performed  for post-operative   decompression   of  the  CBD if  outflow  obstruction   occurs.  The  T-tube acts as a foreign body around which bile pigments and bile salts may precipitate,  and the incidence of recurring stones would be greater in patients with choledochotomy followed  by  T-tube  drainage.51  Significant bile  leak  following  T-tube  removal  is said to  occur  in  a  high  percentage  of  cases.52

Moreover, T-tube drainage is associated with increased bile infection and wound infection. The  other  reasons  for  considering  the  use of   T-tube  drainage   after   choledochotomy are  to  extract  the  retained  stones  through the  T-tube tract  and  to  make  postoperative radiologic visualization ofthe  CBD.23,49,50,53

But   these   objectives   can   also   achieved with       intra-operative        choledochoscopy and post-operative  ERCP. Intra-operative choledochoscopy   can  decrease  residual stones to a large extent and make sure unobstructed CBD under direct observation during operation.  If there are residual stones by any chance, the  stones  can  be extracted by ERCP, and  biliary  drainage  can recover

similarly.54-56  Sawyers  et  aP1  documented

the advantages of primary closure ofthe CBD and recommended abandonment ofthe routine use of a T-tube following  CBD  exploration. T-tubes are not only expensive but are also associated   with   prolonged    hospital   stay and complications such as retained stones, retained                  T-tube   fragments,    inflammatory polyps,         sepsis,    premature    dislodgement, biliary   fistula,   late  biliary   stricture,   bile leakage and peritonitis.l0,22,24,32,52,57-62 The use ofthe T-tube was considered appropriate only in cases of retained impacted stones that would require endoscopic extraction, serious cholangitis  with frank pus in the CBD, or a

very thin CBD.45,47,63

In Ambreen et aF study, they found two cases  of  bile  leakage  in  patients  in  whom

case among the 16 patients (6.3%)  in whom primary closure of the CBD was done. Yamazaki  et  al9  reported  an  incidence  of

11.7% and 5.8% respectively. On the other hand, other authors reported no cases of bile leakage after primary closure.29,30

Primary closure of CBD following routine choledochotomy was a safe alternative to   the    insertion    of   a   T-tube _7,20,21,23,64

Gurusamy et al65,66 performed two meta­ analyses   with   regard  to   primary   closure versus T-tube drainage after either open or laparoscopic  common  bile  duct  exploration in  2007  using  data  from  six  studies  and one study, respectively, which reached a conclusion that primary closure after CBD exploration seemed at least as safe as T-tube drainage. But the number of patients included was small and the up-to-date studies were not included.

In fact, a '12-year  follow-up' study found

that the diameter of the dilated CBD returns to preoperative normal or near normal values in 75% of patients after surgical exploration of the  CBD  and extraction  of the stones.67

Several  studies   had  showed   that  residual stone rate was low (near 0%) after primary closure because of the application of intra­ operative choledochoscopy.7,20,21

Zhu  et al68 in their  meta-analysis demonstrated  statistically  significant difference  for  operating  time  and postoperative  hospital stay and the total cost of  treatment  between  primary  closure  and T-tube  drainage  groups  after  common  bile duct  exploration  for  choledocholithiasis.  In the primary closure group, patients remained in the hospital for a shorter period and were not burdened by aT-tube. In patients where the   T-tube  has  been  kept  in  place,  there was the additional cost of postoperative cholangiography.  Their meta-analysis tended to favor primary closure overT-tube drainage in the prevention of the development of post­ operative complications.  In addition, it is unacceptable and uncomfortable  for patients to go home with a functioning T-tube, and the risks of dehydration  and saline depletion  in such patients at home are contraindications to

this technique.21 On the other hand, the old latex tube was very irritant and could safely be removed within a week or so. But the current siliconised T-tube requires 4-6 weeks in situ to produce a reliable tract. This increases the morbidity and discomfort ofT-tube drainage for the majority of patients. Wu et al69 in their meta-analysis  indicates that  primary closure of the common bile duct is safer and more effective than T-tube drainage for LCBDE. Therefore, they do not recommend routine performance ofT-tube  drainage in LCBDE.

Primary  closure  during  emergency  CBD

exploration   is  furthermore   controversial. 45

In  the   present   case   series,   12%  of   the CBD  exploration  was  done  on  emergency basis and still no T-tubes were inserted. Alhamdani et al45 performed primary closure of choledochotomy  after emergency CBD exploration and reported its safety and feasibility.

No  major  complications   and  no  deaths

occurred in this study. Intraperitoneal leakage with   subsequent   biliary   peritonitis   have been reported.l,l6,22 No such complication occurred  in this  study.  The  reason  for  this was probably that choledochoscopy  and IOC were used to ensure complete duct clearance and  the  lower  end  of  the  CBD  was  not probed.  This  is  beside  delicate  suturing  of the  CBD  incision.  These  measures  reduced the risk of biliary leakage. Interrupted sutures are recommended with absorbable material, which  may reduce  the  recurrence  of stones and stenosis ofthe CBD.

Bile leakage following primary closure is a major criterion for  assessing the safety of this procedure. In this study, only one patient (1.4%) suffered from bile leakage; this is comparable to the bile leak rates of 2-4.5% reported  by  others. 45,47,48  The  case  of  bile leak reported in this study may be from the duct of Luschka or from the choledochotomy site.   However,   the   bile   was   completely drained by the non-suction catheter and its volume was decreasing and subsided on the third postoperative day.

There are many advantages of primary closure   after   CBD   exploration,   including early   discharge   from   hospital,   decreased

post-operative  complications, and no discomfort due toT-tube. Early discharge from hospital means an early return to work, which further has an indirect effect on the expenses of  the  patient.27  In  a  developing   country like  Egypt,  this  difference  in  expenditure has a major impact on public health. Many papers support the direct closure of the CBD immediately after exploration.l6,23,27,65,66

The fact remains that much of the equipment and training available to the developed  world  are  still  not  available  in the   Third-World   setting.   Many   surgeons in limited resource settings are very well experienced with the open techniques; hence open  biliary  surgery  has  its  specific  role to play in these settings. Interestingly, the confidence level of surgical residents in the modem  'laparoscopic' era are low due to minimal exposure to open techniques and are not able to perform better in critical situations requiring an open approach.

Conclusion:

Primary closure of the CBD after open choledochotomy  is a safe, feasible  and effective approach to the management of choledocholithiasis  that offers a single-stage treatment,  a low morbidity  rate, a low cost, and a short postoperative hospital stay.

Primary closure can improve the quality of

life and avoid the complications  specifically associated with the use of a T-tube for biliary drainage.

The most important point for primary closure  is  to  ensure  that  all  CBD  stones are   retrieved,   confirming   their   clearance by choledochoscopy and intraoperative cholangiography. Careful suturing of the choledochotomy site must be done to prevent bile leakage or stenosis.

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