Early Laparoscopic Cholecystectomy Versus Percutaneous Cholecystostomy Followed by Delayed Laparoscopic Cholecystectomy in Patients with Grade II Acute Cholecystitis According to Tokyo Guidelines TG18

Introduction

Over the last few decades, the treatment of acute cholecystitis (AC) has evolved. Historically, conservative treatment was the main line of treatment for the majority of patients. The practice of delayed cholecystectomy was even debatable. This concept was questioned by strong evidence from several reports confirming the efficacy, safety, and shorter hospital stay of immediate cholecystectomy and eventually, early laparoscopic cholecystectomy (LC) in specialized centers became the recommended treatment for patients with AC.^1–7 In the clinical practice, despite recommendations that endorse initial cholecystectomy, the nonsurgical management is frequently followed in around half of the patients admitted to hospital with this diagnosis,^3,8 although a failure rate as high as 32% of cases, a protracted hospital stay, and higher hospital expenses were reported.^7,9

Conversely, LC in the setting of AC is a technically demanding procedure because of the high frequencies of biliary injuries produced by problems associated with anatomical demarcation. ¹⁰ High conversion and complication rates as high as 40%, in cases of intense inflammation, can be realized.^11–14 The burden is much worse in high-risk patients such as the elderly and those with medical comorbidities, among whom mortality rates of 18%–50% were reported.^15,16

Because of these concerns, there was a need to categorize patients with AC associating the severity of inflammation to the expected difficulty of LC to suggest an appropriate safe management. Several classifications were issued but notably, the Tokyo Guidelines, which have been updated in 2018 as TG18, ¹⁷ recommended principles for the diagnosis and management of AC and distributed patients with AC into three grades of inflammation: mild (grade I), moderate (grade II), and severe (grade III). The TG18 also proposed treatment preferences based on the gravity of the AC. Grade I patients should undergo early LC; grade II patients can have either LC or percutaneous cholecystostomy (PC); and grade III patients should simply receive PC. ¹⁸

In 1980, Radder ¹⁹ was the first to report the technique of ultrasound-guided PC under local anesthesia. The underlying principle of this procedure is to decompress the bile from the gall bladder externally, thus relieving the attack of AC. ²⁰ PC can be performed as a definitive treatment in cases of acalculous cholecystitis and in patients with poor general condition, as a bridging procedure to LC or as a salvage procedure in case of failure of medical treatment for AC, as pointed out by Hatzidakis et al. ²¹ Nevertheless, the procedure is not devoid of complications such as bile leakage, hemorrhage, colonic injury, and vasovagal reactions.^22,23

In patients classified as grade II AC by Tokyo guidelines for AC, it is unclear which patient is indicated for early LC and which is indicated to PC. ⁶

The aim of this study was to compare LC performed either immediately during the attack or delayed after PC in selected patients presenting with complicated AC.

Methods

In the period from June 2017 to January 2023, the medical files of all patients who were admitted with complicated AC were retrospectively reviewed. The target group of the current study was patients with one of the parameter stated by grade II (moderate) Tokyo guidelines (TG18) for severity grading of AC ¹⁷ who were managed either by early LC or by a bridging PC followed by delayed LC. The four parameters for Tokyo classification examined were: duration of complaints more than 72 hours, leukocytic count more than 18,000/cm³, palpable tender gall bladder, and severe local inflammatory signs around the gall bladder in the absence of organ dysfunction. Patients who had grade I or III AC, common bile duct stones or jaundice, liver cirrhosis, severe upper abdominal adhesions, acalculous cholecystitis as well as those suffering from major comorbidities in which laparoscopic surgery is contraindicated were excluded. In addition, those who followed a conservative treatment for AC were also excluded. The study protocol was approved by the Ethics Committee of our institution.

The records were examined for demographic data, presentation, initial management including laboratory and imaging findings, operative data, postoperative period and follow-up. According to these data, patients were classified into two groups. Group A (130 patients) underwent emergency LC and group B (90 patients) was subjected to PC followed by a subsequent interval delayed LC after a period of 6 weeks at least. The decision in each group was made by the treating physician. The operative data of the early and delayed LC group were analyzed.

Ultrasound-guided PC was carried out by the interventional radiologists under local anesthesia. The transhepatic approach was the preferred approach because of the lower risk of bile leakage. The transperitoneal approach was used in case of an enlarged gallbladder in intimate relation to the abdominal wall or in case of failure of the transhepatic approach. A disposable abdominal drainage catheter (10 Ft) of the locking type was employed (Diall, Medison jaya raya, Jakarta, Indonesia). Bile samples were aspirated and sent for culture sensitivity. In conjunction with PC insertion, patients received medical treatment of parenteral quinolones, antispasmodics, intravenous fluids, antiemetics, and analgesics. Oral fluids were allowed once vomiting stopped. Similarly, data related to the procedure and its complications were recorded. Cholangiogram was not routinely performed as the PC catheter was left till the time of LC to continuously drain the gall bladder and prevent a recurrent attack of AC.

In groups A and B, LC was performed by the standard four-port technique. In LC performed after PC (group B), the catheter stocks the gall bladder to the abdominal wall. To aid gall bladder retraction, gentle separation was conducted from the epigastric trocar using hook diathermy (Fig. 1). The transhepatic catheter, inserted just below the costal margin, was then removed by cutting the locking thread from outside, as it impedes gall bladder retraction from its fundus.

OPEN IN VIEWER

FIG. 1.

Gallbladder attached to an abdominal wall by a cholecystostomy catheter.

The primary outcome was to compare the feasibility and safety of each approach in terms of operative and postoperative complications. Clinical symptoms, laboratory data, and radiological evidence, such as ultrasonography or computed tomography, were used to make the diagnosis of AC. Postoperative complications were defined as adverse events occurring within 30 days of each LC. The complications were graded according to the Clavien–Dindo system. ²⁴ Hospital stay in group B was measured for the duration of hospital stay for only the delayed LC.

Results

A total of 220 patients meeting the eligibility criteria based on grade II of TG18 for severity grading of AC were included. They were classified into two groups: 130 patients were managed by early LC (group A) and 90 patients were managed delayed LC after PC (group B).

Discussion

Currently, Tokyo guidelines are widely used for the classification and management of patients presenting with AC. In grade II, either immediate LC or PC is appropriate. ⁶ The goal of this report was to compare the difficulty of LC with each approach in terms of operative difficulties and postoperative morbidity.

The present data show that patients with moderate AC who underwent early LC as recommended by Tokyo guidelines were different from those who underwent PC as regards the underlying general condition, older age, more male gender, and higher ASA score. Moreover, they had significantly higher operative and postoperative complication rates. The vast majority of patients who underwent PC were judged as high risk for anesthesia and surgery at the time of their initial consultation.

Based on TG18, our target group lied in the midst of the two AC extremes; the decision in one extreme is straightforward LC (grade I) and in the other is a straightforward PC (grade III). A great effort was undertaken to retrospectively categorize patients from our database as grade II, and then to follow their fate whether they underwent PC or LC. We opted to examine the results of the suggested treatment of Tokyo guidelines on our patients. Some of our patients were initially treated conservatively, but when medical treatment did not work, they were referred to urgent LC. In group B, we included patients who received PC and on follow-up, and they were considered fit for LC. With these concepts in mind, patients, in whom conservative strategy followed by LC after a variable period of time was successful, were ruled out as our goal was following the recommendations of Tokyo guidelines (PC or LC).

In patients who underwent two-stage procedure (PC followed by LC), the indication was clear from the start, to bridge the patient till he becomes fit to undergo LC. This was in contrast to other studies,^1,25–29 in which PC was employed as a definitive alternative treatment for patients considered at high risk of general anesthesia. The transhepatic approach was our preferred approach (76 patients, 84.4%) because it provides early tract maturation reducing the incidence of bile leak (none of our patients), far from the transverse colon, and it gives more stability to the catheter to decrease the risk of dislodgement. ³⁰ The transperitoneal approach was used in 14 patients (15.6%) and incurred bile leak in 3 patients.

One of the major problems is that PC is invasive and may lead to procedure-related complications, the most serious side effect of which is catheter dislodgement, with a reported incidence of 5%–10%.^31,32 In the present study, this was observed in 7 patients (7.8%) necessitating re-admission for catheter exchange via the transhepatic access, as it provides lesser incidence of redislodgement. Four of them after the transhepatic pathway and 3 after the transperitoneal pathway. Mostly, this was caused by unintentional traction on the catheter or by unexpected falls, particularly in careless patients. Dislodgement was not a frequent complication, as the catheter used in this study was coiled and that is difficult to be detached. Catheter exchange increases the cost and suffering of the patient. Another reported drawback of PC in all patients was the significant patient discomfort, inconvenience with daily life, and difficulties related to bag evacuation, dressing, and care around the catheter.

LC after PC is an elective procedure. Accordingly, the goal is to avoid performing LC in hostile conditions. In the current data, the mean period between PC and LC was 2 months (60.15 days). This is shorter than the 3-month recommended duration by TG13. The ideal timing of LC after PC is still a matter of debate. Proponents of early LC within the first month argue that there is no relation between the timing and operative time and intraoperative blood loss. Akyurek et al. ³³ pointed out that, in high-risk patients, early LC within 96 hours after PC was safe and had less conversion, shorter hospital stay, and lower cost than conservative treatment. The time reported by Kim et al. ³⁴ was 1 week. Inoue et al. ¹⁸ suggested 9 days (216 hours) as an ideal cutoff value as the rate of postoperative complications, particularly intra-abdominal abscess, was reduced when the operation was performed after 216 hours after placement of PC. Chikamori ³⁵ performed LC 1–2 weeks after PC. Jung et al. ⁵ suggested 10 days as the minimum time to perform LC after PC. Those who favor delayed LC after 3 months^17,26,34 preferred the safety and complete resolution of all inflammation and edema before proceeding to LC. However, procedure-related complications increase with the increase in waiting time. ⁵ Han et al. ²⁶ examined early and late LC following PC and found that those who received early LC had a shorter hospital stay and lower health care costs. Deferred LC, on the other hand, offered the advantages of a shorter operative duration and a reduced rate of complications. In the end, no timing was shown to be superior to the other. Based on the pathogenesis of necrotizing cholecystitis and fibrosis, which are at their maximum on the 10th day of the onset of AC,^36–38 we feel that earlier LC at 2 months is appropriate and avoids the late complications of PC. In a sense, the time period should be individualized for each patient according to the general condition.

A successful early LC obviates the need for a second procedure, has a smooth postoperative course, and provides less wound-related complications and a shorter hospital stay. Group A had significantly longer operative time related to the difficulty of the operation, obscure anatomy, and biliary and bowel injuries. The conversion rate was therefore higher (19.2%) than group B (5.6%). Furthermore, a greater number of postoperative complications noted were also related to the difficulty of the operation. The suboptimal results in group A can be explained by several reasons. They were performed in emergency settings by junior staff of varying degrees of experience, sometimes in the late night, in unprepared patients. In reports with satisfactory outcome after early LC,^1,3–5,7,39 the authors did not specify the grade of AC. We feel that these favorable results were met in grade A patients performed in highly qualified centers; however, these data cannot be translated in grade B or C AC.

Severe local inflammation of the gall bladder including empyema can be difficult to diagnose before surgery. The patient’s history, clinical examination, laboratory results, and even ultrasound findings are all similar to simple cholecystitis. The surgeon can be faced with this unpleasant surprise, making LC a hard mission to accomplish associated with high conversion and morbidity rate. ⁴⁰ In 2017, Inoue et al. ¹⁸ stated five parameters of difficult LC: conversion, subtotal cholecystectomy, necrotizing cholecystitis or pericholecystic collection, tight adhesions around the neck of the gall bladder, and failure of transhepatic PC insertion. Empyema of the gall bladder represent the most difficult cholecystitis. Malik et al. ⁴¹ treated 67 patients with empyema by LC, the procedure was successful in 54 patients (80.6%). A conversion rate of 42% was registered by Al-Jaberi et al. ⁴² when addressing 12 cases of empyema of gall bladder laparoscopically. The diagnosis of empyema was made intraoperatively characterized by an intensely inflamed gallbladder including frank pus and a cystic duct blockage.

In comparison, group B had a less difficult LC. Not only was there relief of inflammatory reaction and edema but also the PC catheter was left in situ till the time of LC, ensuring continuous aspiration of pus and at the same time, avoiding the problems of cystic duct obstruction after removal of PC. It was noted that, in group B, gall bladder stones became friable with the catheter besides (rarefaction), probably related to hindering of the process of stone calcification, facilitating bladder grasping. In a separate article, ⁴³ it was found that a lower Charlson comorbidity score and few abdominal operations were associated with successful interval LC after PC. Sanjay et al. ⁴⁴ reported inferior outcome after PC was inserted in 53 patient with a median age 74 years ,most of them ASA II and III grades, 14 patients (26.5%) were subjected to LC in which 2 cases (14.3%) only were completed laparoscopically. In total, 22% of patients experienced recurrent cholecystitis after removal of the PC catheter that was removed after 6 weeks.

We had a total conversion rate of 13.6%; 19.2% in group A and 5.5% in group B. In the data herein, biliary injuries were the most common cause of conversion in group A (40%), followed by obscure anatomy (24%). A palpable tender gall bladder proved to be an important risk factor for both conversion and bile injuries. Vague anatomy, uncontrollable bleeding, and colon and bile injuries are the reported reasons for conversion in the literature.^26,30,42,45 Duodenal injuries were difficult to repair laparoscopically, as they required adequate mobilization of the duodenum. Conversely, we were able to successfully repair two colonic injuries (2/4) in the mobile transverse colon.

Postoperative problems were much reduced in the PC group, owing to the virtues of PC and shorter operation duration. The lack of perioperative mortality can be explained by the fact that our patients were younger than the mean age in other studies where a mortality rate was recorded. Those who were not subjected to subsequent LC were excluded. In fact, by decompressing biliary sepsis, PC assisted us in saving the lives of patients in critical condition.

This study had a simple design covering a large number of patients with AC stratified as grade II AC. A strict intention to treat criteria for PC was made by bridging the patient to LC converting LC from an emergency to an elective operation. All our patients made it through the perioperative phase alive. A correlation between the four parameters of TG18 and operative outcomes was made. The most impressive drawback was the selection bias caused by the retrospective character of the study, which resulted in significant discrepancies between the two groups. Our justification is that it mirrors reality.

In our experience, among moderate AC patients, those with higher risks (age more than 70, male, ASA III), PC placement is helpful in bypassing the critical period and avoids organ dysfunction. A time interval of 2 months between the time of PC and subsequent LC is proposed. In general, LC after PC was easier than early LC. Local inflammation is an indicator for potential complications if LC was performed first.

Based on our data, those diagnosed as grade II according to TG18 with local inflammation and probably palpable tender gallbladder should be managed by PC-first strategy, otherwise LC-first can be performed. LC for AC should be only performed by experienced surgeon in well-equipped center with excellent resources. PC in recommended in low experienced centers to avoid complications and difficulties. We recommend leaving the PC catheter till the time of surgery to avoid recurrent AC if the cystic duct was still blocked and to drain the gall bladder and facilitate operative handling of the organ.