POSSIBILITIES OF ONE-STAGE MANAGEMENT OF COMPLICATED CHOLELITHIASIS WITH USE OF INTRAOPERATIVE ANTEGRADE ENDOSCOPIC PAPILLOSPHINCTEROTOMY IN URGENT SURGERY Alekseev N.A., Baranov A.I., Snigirev Yu.V., Snigirev A.Yu.

Novokuznetsk City Clinical Hospital No.5,

Novokuznetsk State Medical Extension Course Institute – the Branch of Russian Medical Academy of Continuous Professional Education, Novokuznetsk, Russia

Despite of great achievements and new technologies in surgical management of complicated form of cholelithiasis, the importance of this disease is still actual. According to results of examinations, cholelithiasis is identified in 8-25 %, and in 30 % in older persons. In acute cholecystitis, the incidence of cholelithiasis reaches 35 % [1, 2].

The improvement in low invasive techniques, which minimize the surgical trauma, allowed extending the possibilities of surgical correction of pathology [3, 4]. However in this case, the realization of correction of abnormality of biliary ducts requires for participation of physicians of several related specialties (surgeon, endoscopist, radiologist). According to the literature data, the preference is given to multi-stage technique for surgical management of complicated cholelithiasis, when the first stage means the retrograde endoscopic papillosphincterotomy (REPST) with transpapillary manipulations, the second stage – cholecystectomy [5, 6]. At the same time, realization of retrograde interventions is accompanied by complications (bleeding, retroduodenal perforation, acute pancreatitis, acute cholangitis, septic shock) from 1 to 19 % [7, 8, 9]. Despite the high amount of different variants of surgical management of cholecystocholedocholithiasis (one- and two-staged treatment), the advantages have not been properly studied, and the most optimal technique is unknown, that is important for urgent patients [10, 11, 12].

Objective – to evaluate the effectiveness of performing intraoperative antegrade endoscopic papillosphincterotomy in one-step surgical management of cholecystocholedocholithiasis and two-step management with retrograde endoscopic papillosphincterotomy for emergency patients.

MATERIALS AND METHODS

In 2010-2015, 624 patients (women – 72.3 %, men – 27.7 %, mean age – 61.3 ± 13.9) received the surgery. The patients were urgently admitted with the complicated form of cholelithiasis. The one-stage treatment of cholecystocholedocholithiasis was conducted on the basis of clinical data, which indicated the complicated forms of cholelithiasis, and laboratory examination. The main technique of cholecystocholedocholithiasis diagnostics was ultrasonic examination (USE). Also the results of fibrogastroduodenoscopy (FGDS) were considered.

The one-stage surgical management was conducted for 188 (30.1 %) patients who could not receive transpapillary manipulations due to organic pathology (duodenal deformation, mass lesions in region of major duodenal papilla (MDP), fixed concrement in distal part of choledoch duct), previous gastric resection by B-II. Also the one-stage management was used for patients with scar-inflammatory changes in gall bladder and hepatoduodenal ligament. For such patients, the surgical treatment was conducted with the mini-approach or laparotomy approach.

Two-stage surgical management was used for 436 (69.9 %) patients with the inflammation signs (cholangitis, pancreatitis) diagnosed with the clinical and laboratory indices, and with ultrasonic data of multiple choledolithiathis, big stones in biliary duct, and significant (more 13 mm) increase in diameter of hepaticocholedochus.

Intrasurgical antegrade endoscopic papillosphincterotomy (ISAEPST) is not so popular as REPST according to small number of reports and low amount of described interventions, with limited number of publications [13, 14, 15]. Since the increase in bilirubin over 100 µmol/l elevates the risk of identification of the block of distal part of choledoch duct and big stones, the use of single-stage technique with ISAEPST was limited by this index.

Chronic calculous cholecystitis (CCC), choledolithiasis and obstructive jaundice were the most frequent pathology in the study group. The rarest form of cholecystocholedocholithiasis was choledocystocholedocheal fistula. The table 1 shows the nosological forms of abnormality.

Table 1

Nosological forms of cholecystocholedocholithiasis

Forms of cholelithiasis	(n = 624)
Forms of cholelithiasis	Abs.	%
Chronic calculous cholecystitis. Choledocholithiasis. Obstructive jaundice.	238	38.2
Chronic calculous cholecystitis. Choledocholithiasis. Major duodenal papilla stenosis. Obstructive jaundice.	108	17.3
Acute cholecystitis. Choledocholithiasis. Cholangitis. Obstructive jaundice.	76	12.2
Acute cholecystitis. Choledocholithiasis. Obstructive jaundice.	65	10.4
Chronic calculous cholecystitis. Choledocholithiasis. Cholangitis. Obstructive jaundice.	44	7.0
Acute cholecystitis. Choledocholithiasis.	39	6.3
Chronic calculous cholecystitis. Major duodenal papilla stenosis. Obstructive jaundice.	29	4.6
Mirizzi syndrome. Obstructive jaundice.	25	4.0

Among urgently admitted patients with cholecystocholedocholithiasis, obstructive jaundice was identified in 585 (93.8 %) cases. It was noted that the duration of jaundice up to 7 days was in 394 patients (63.1 %), 7-14 days – in 140 (22.4 %) patients, more than 2 weeks – 90 (14.5 %).

ASA (American Society of Anesthesiologists) criteria were used for estimation of degree of surgical and anesthesiological risk. The distribution into categories was presented as follows: ASA I – 71 (11.4 %), ASA II – 346 (55.4 %), ASA III – 190 (30.5 %) and ASA IV – 17 (2.7 %).

Correction of pathology of extrahepatic biliary ducts was conducted with the combined method of endoscopic interventions depending on an identified pathology: ISAEPST, REPST in various combinations, lithoextraction, mechanic biliary lithotripsy (MBL), transpapillary draining (nasobiliary draining (NBD), biliary duct stenting). The non-common techniques of papillosphincterotomy were used in identification of peripapillary diverticle, stone impacted into MDP, full blocking of distal part of biliary duct. Depending on sizes, number of stones and presence of cholangitis, the further treatment was defined.

The patients with cholecystocholedocholithiasis received the whole range of surgical approaches: low invasive interventions (laparoscopic cholecystectomy (LCE), minicholecystectomy (MCE), standard laparotomy (SCE). Intrasurgical cholangiography (ISCG) was conducted in 100 % of cases.

In compliance with requirements of biomedical ethics, the informed consent was received for all participating patients. The study protocol was approved by the ethical committee of Novokuznetsk State Medical Extension Course Institute.

Descriptive statistics was used for systematization, visual presentation of material in view of charts and tables and their quantitative description. The quantitative data was presented as the mean (M), standard deviation (m). The qualitative sign were presented as absolute values (n) and percentage (%). The non-parametrical methods were used for estimation of statistical significance of intergroup differences with use of Mann-Whitney U-test. P ≤ 0.05 was considered as critical level of significance in testing the statistical hypotheses.

RESULTS AND DISCUSSION

The laparoscopic approach was main in one-stage management of cholecystocholedocholithiasis. It was used for 157 (83.5 %) patients. 92 patients received LCE, ISAEPST and removal of biliary duct concrements. External draining of biliary duct completed the realization of LCE with ISAEPST in 22 patients; it was associated with the fact that some events of inflammation in biliary duct, big concrements and their high number were found during transpapillary interventions, with high hyperbilirubinemia.

During one-stage management with LCE and ISAEPST, 27 (14.4 %) patients required for MBL. Presurgical ultrasonic examination showed the biliary duct wider 21 mm in 21 patients. Totally, 47 patients showed the presurgical extension of common biliary duct of 12 mm and more. Therefore, the biliary duct diameter > 12 mm, according to presurgical USE, supposed MBL in 44.6 %.

Conversion to the mini-approach was realized for identified intrasurgical Mirizzi syndrome in 2 patients. One patient had laparotomy and bleeding arrest from MDP, which appeared due to technical difficulties during ISAEPST (a big concrement in biliary duct).

Mini-approach in one-stage management was used for 16 (8.5 %) patients. ISAEPST in combination with MCE was conducted for 6 patients. After surgery with IAEPST, 5 patients received external draining of biliary ducts. 3 patients required for choledochojejunostomy from mini-laparotomy approach. It was associated with identification of big concrements in hepatic choledoch duct, cholangitis and hyperbilirubinemia at the background of significant (more 20 mm) extension of gall bladder. These patients had no endoscopic approach to MDP. ISAEPTS and separation of bladder-choledoch fistula was conducted in 2 cases.

15 patients (8 %) received the traditional laparotomy approach in one-stage management. 6 patients received laparotomy, cholecystectomy and ISAEPST. 4 patients required for completion of hepaticocholedochus with external draining. 2 patients required for choledocholithotomy, choledochoscopy with choledochojejunostomy for inflammatory infiltrate in subhepatic space at the background of absent approach to MDP. ISAEPST from laparotomy approach was conducted at the background of Mirizzi syndrome for 3 patients.

26 patients received ISAEPST from mini- and laparotomy approaches at the background of evident inflammatory-infiltrative process in the region of duodenum, gall bladder and hepaticoduodenal ligament. This situation did not require for duodenotomy and choledochotomy, and, as result, did not require for minimization of perisurgical complications.

Two-stage surgical management of cholecystocholedocholithiasis was urgently used for 436 patients. 330 (75.7 %) patients received the first stage surgical management during the first day. They had the clinical signs of acute blocking of distal part of choledochus, high indices of hyperbilirubinemia, cholangitis. In 106 (24.3 %) cases, the first stage was realized after presurgical preparation (correction of water-electrolytic disorders, coagulopathy).

At the first stage, REPST with lithoextraction was conducted for 190 (43.6 %) patients. 130 (29.8 %) patients required for MBL. The need for bile duct stenting through MDP appeared in 112 (25.7 %) patients, when multiple choledolithiasis, inflammatory stenosis of the common bile duct, bile duct concrements difficult for surgical removal, as well as retrograde cholangiography were identified. 80 (18.3 %) patients needed for NBD. Usually, NBD was realized in presence of events of purulent cholangitis, need for multi-stage treatment, hepaticocholedochus stenosis with inflammatory infiltrate and severe cholestasis. NBD decreased the necessity for additional retrograde revision with aim of receiving of information on abnormal changes in choledochus and monitoring of characteristics and volume of bile. At the first stage, 192 (44 %) patients required for transpapillary draining of hepaticocholedochus (NBD, stenting).

Almost a half (n = 215, 49.3 %) patients with two-stage management had the recurrent retrograde transpapillary interventions. When estimating the diameter of choledochus among 215 patients with recurrent retrograde manipulations, 171 (79.5 %) patients had the presurgical ultrasonic data of choledochus diameter of 12 mm and more. Totally, the diameter of 12 mm and more was diagnosed in 284 (65.1 %) patients with two-stage management. Moreover, most of them needed for recurrent retrograde interventions (60.2 %). The identified findings (i.e. choledochus diameter ≥ 12 mm) can be a prediction criterion for recurrent surgical interventions.

After retrograde revision at the first stage, the second stage was immediately planned for 47 (10.8 %) patients due to inefficiency of endoscopic retrograde removal of identified pathology.

At the second stage, as well as in one-stage treatment, the preference was given to low-invasive techniques of surgical intervention. LCE was conducted in more than in half of cases – 238 (54.6 %) patients. So, peroral cholecystography (PCG) was the obligatory component of intrasurgical diagnosis which identified residual concrements in bile ducts in 31 (13 %) patients. This pathology was removed intrasurgically by means of retrograde endoscopic removal of concrements under control of duodenoscope. 2 patients required for choledochotomy and removal of concrement since the concrement was fixed in the choledochus. 17 patients required for external draining of choledochus.

The need for transition to the mini-approach appeared in 2 patients since infiltrative changes in region of common bile duct at the background of Mirizzi syndrome were diagnosed during surgery. The intrasurgical inflammatory destructive infiltrate in subhepatic space at the background of acute cholecystitis was the reason for TCE in 2 patients.

The mini-approach after the first stage was used for 137 (31.6 %) patients with cholecystocholedocholithiasis. Cholecystectomy from the mini-approach was conducted for 77 patients. Moreover, during surgery after PCG, residual choledolithiasis was identified in 8 patients. It was corrected in retrograde manner during the intervention.

MCE was used for 12 patients with Mirizzi syndrome. After separation of the fistula and removal of concrements from biliary duct, choledochoscopy was obligatory. The intervention was completed with hepaticocholedochus plasty (n = 8) or with formation of choledochoduodenoanastomosis (n = 4).

Dilatation of hepatocholedochus more than 20 mm at the background of multiple big concrements was the cause of choledochoduodenostomy in 10 patients. MCE was combined with choledochotomy and lithoextraction and choledochoscopy in 38 patients.

The inflammatory destructive changes in acute cholecystitis required for transition to the laparotomy approach in 1 patient since differentiation of tissues from the mini-approach was difficult.

Traditional surgical approach was planned for 61 (13.8 %) patients after the first stage. Cholecystectomy was performed for 26 patients. Intrasurgically, residual choledocholithiasis was diagnosed in 7 patients. The concrements were removed in retrograde manner with use of the duodenoscope.

Choledocystoledocheal fistula was the cause of TCE in 8 patients. In all these patients, choledochoscopy was the intrasurgical medicodiagnostic standard. Since the patency of the distal part was restored after the first stage, the final stage included the hepatocholedochus plasty with T-shaped drain for 7 patients. One patient had the formed biliodigestive conjunction.

The big diameter of hepatocholedochus and big multiple choledolithiathis were the reasons for formation of anastomosis in 7 patients. 20 patients required for external draining of hepaticocholedochus at the final stage.

After the first stage, intrasurgically, after PCG, the biliary duct concrements were diagnosed in 46 (10.6 %) patients. The analyzed group of the patients showed that normalization of clinicolaboratory values had happened by the days 2-4 after one-stage management, and by the days 4-8 after two stages (the table 2).

Table 2

Duration of normalization of clinical and laboratory values after surgical treatment, М ± m

Values	Number of days for single-step management			Number of days for two-step management
Values	Laparoscopic cholecystectomy, n = 157	Minilaparotomy cholecytectomy, n = 16	Standard cholecytectomy, n = 15	Laparoscopic cholecystectomy, n = 238	Minilaparotomy cholecytectomy, n = 137	Standard cholecytectomy, n = 61
Body temperature, °С	2.3 ± 0.64	2.4 ± 1.1	3.5 ± 1.29	4.3 ± 1.26^*	4.8 ± 1.64^**	6.1 ± 1.79^***
LII	2.2 ± 0.51	3.6 ± 0.72	3.6 ± 0.87	6.2 ± 0.78^*	7.5 ± 1.3^**	7.5 ± 1.16^***
Amylase, U/l	-	-	-	3.4 ± 0.88	3.6 ± 0.65	3.9 ± 0.70
Note: ^* – difference between values for laparoscopic cholecystectomy (p < 0.05); ^ – difference between values for minilaparotomy cholecytectomy (p < 0.05); ^* – difference between values for standard cholecytectomy; LII – leukocytal intoxication index.

Estimating the efficiency of surgical management of cholecystocholedocholithiasis, we can see that the low invasive approaches result in faster posttraumatic rehabilitation of patients, considering the time course of decrease in hyperthermia and LII. This trend was noted both in one- and two-staged management. One should note that patients with one-stage management had less severe basic condition.

For objective estimation, all postsurgical complications were distributed into two categories: 1) associated with manipulations for MDP; 2) associated with a surgical approach.

In urgent situation with one-stage correction of pathology of biliary ducts, the complications of the first category relating to ISAEPST and transpapillary manipulations were noted in 1.1 % (n = 2) of cases (1 – bleeding from MDP; 1 – acute pancreatitis without need for surgical correction).

The use of two-stage surgical management was accompanied by the complications of the first category after REPST and transpapillary intraductal interventions in 3 % (n = 13):

- postpapillotomic bleeding, which was noted in 5 (1.15 %) patients; 1 patient required for realization of traditional laparotomy, hemostasis due to inefficiency of combined pharmacological and endoscopic hemostasis;

- acute pancreatitis caused by endoscopic retrograde manipulations for MDP were identified in 5 (1.15 %) patients. 4 patients reached the positive time course by means of intensive care (4.9 ± 1.2 days). One patient received laparotomy because of progression of the acute process;

- 2 (0.46 %) patients received the fixation of basket forceps on the intraductal concrement. This problem was solved through the traditional laparotomy approach;

- 1 (0.23 %) patient required for laparotomy due to retroduodenal perforation.

The transitory increase in blood amylase without signs of acute pancreatitis after antegrade interventions for MDP was registered in 1.06 % of cases, after retrograde interventions – in 13.07 %.

Therefore, we registered the significant decrease in complications relating to manipulations with MDP in the antegrade approach – 1.1 % vs. 3 % after retrograde one.

The approach-related complications (category 2) were in patients who received the one-stage treatment (5.8 %): complications were diagnosed 2 patients in laparotomy; the mini-approach was used for 3 patients; complications were registered in 6 patients after traditional laparotomy. The high amount of complications of the second category after one-stage correction of cholecystocholedocholithiasis from the mini-approach and the traditional laparotomy approach were determined by surgical injury (the number of wound complications increased with increasing size of an incision) and by the fact that choice of these approaches was often determined by contraindications for overlay of pneumoperitoneum owing to severe basic condition of the patient which was caused by purulent septic, cholestatic complications of cholecystocholedocholithiasis, and as a rule, concurrent decompensated somatic pathology.

The patients with two-stage management showed the complications of the second category in 3.7 % of cases at the second stage. These patients showed the high amount of complications of the approach along with extending the surgical approach. So, for LCE, the complications were fixed in 3 patients, for MCE – in 5, in traditional laparotomy – in 8.

The lower amount of complications in two-stage management (4.2 % as compared to one-stage management) is explained by the fact that the patients were at the moment after correction of acute events and jaundice at the second stage.

Among all patients, 5 (0.8 %) lethal outcomes were registered: 2 patients with one-stage treatment, 3 – with two-stage one. In both groups, the lethal cases were not associated with techniques of treatment. The patients were in the group 4 according to ASA and they had severe main and concurrent abnormalities.

3 patients had some situations, which had required for conversion of the laparoscopic approach in one-stage management: 1 patient received laparotomy, bleeding arrest from MDP after ISAEPST; 2 patients received the mini-approach for cholecystocholedocheal fistula. The similar situations requiring for conversion of the approach at the two-stage management were observed in 5 patients: 2 patients received the mini-approach for cholecystocholedocheal fistula and scar-adhesion changes in gall bladder and hepatoduodenal ligament. 3 patients received the traditional laparotomy due to inflammatory infiltrate at the background of acute destructive cholecystitis and, as result, difficulties in tissue differentiation.

Also, estimating the treatment results, we noted that the use of one-stage management allowed deceasing the time of stay in ICU and in the hospital (the table 3). The use of ISAEPST was efficient for 29.3 % of patients.

Table 3

Values of efficiency of treatment of cholecystocholedocholithiasis, М ± m

Values	Single-step management				Two-step management
Values	Laparoscopic cholecystectomy, n = 157	Minilaparotomy cholecytectomy, n = 16	Standard cholecytectomy, n = 15	Total, n = 188	Laparoscopic cholecystectomy, n = 238	Minilaparotomy cholecytectomy, n = 137	Standard cholecytectomy, n = 61	Total, n = 436
Bed-days in ICU	0.5 ± 0.4	0.8 ± 0.7	1.5 ± 0.7	1.0 ± 0.5	0.6 ± 0.5	1.2 ± 0.7	2.2 ± 1.1	1.5 ± 0.8^****
Bed-days in hospital	6.8 ± 1.6	7.3 ± 2.5	12.6 ± 1.7	9.1 ± 2.1	13.2 ± 1.3^*	13.8 ± 2.1^**	18.8 ± 1.8^***	15.1 ± 1.7^****
Note:^* – difference between values for one- and two-step management (p < 0.05); ^– difference between values for one- and two-step management (p < 0.05); ^– difference between values for one- and two-step management (p < 0.05); ^***– difference between values for one- and two-step management (p < 0.05).

CONCLUSION

The intrasurgical antegrade endoscopic papillosphincterotomy with one-stage management of cholecystocholedocholithiasis showed its efficiency as compared to two-stage management with retrograde endoscopic papillosphincterotomy in emergency patients. One-stage surgical treatment of complicated cholelithiasis showed the decrease in ICU, surgery unit and hospital stay. Intrasurgical antegrade endoscopic papillosphincterotomy decreased the rate of complications relating to transpapillary interventions (1.1 %) in contrast to retrograde ones (3 %). Intrasurgical antegrade endoscopic papillosphincterotomy with one-stage management of cholecystocholedocholithiasis promoted the correction of almost 1/3 of urgent patients without retrograde interventions for MDP, resulting in the decrease in possible complications.

Information on financing and conflicts of interests

The study was conducted without sponsorship. The authors declare the absence of any clear or potential conflicts of interests relating to publication of this article.