Annals of Emergency Surgery

Cite this article: Abou-Sheishaa MS, Burham WA, Abbas AE, Dawoud IE, Shaker MA, et al. (2018) When to do Laparoscopic Cholecystectomy in Mild Acute Biliary Pancreatitis, Early or Late? Ann Emerg Surg 3(1): 1031.

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*Corresponding authorMohamed Samir Abou-Sheishaa, Department of General Surgery, Mansoura University-Faculty of Medicine, Mansoura city, Goumhoria street, Mansoura university hospital, Main building, second floor, department 7, Ezypt, Tel: 002-01019623935; Email:

Submitted: 24 August 2018

Accepted: 07 September 2018

Published: 10 September 2018

Copyright© 2018 Abou-Sheishaa et al.

ISSN: 2573-1017

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Keywords• Laparoscopic cholecystectomy; Mild acute

pancreatitis

Research Article

When to do Laparoscopic Cholecystectomy in Mild Acute Biliary Pancreatitis, Early or Late?Mohamed Samir Abou-Sheishaa*, Waleed Ahmad Burham, Ashraf Elsayed Abbas, Ibrahim Elsayed Dawoud, Mahmoud Ahmed Shaker, Ahmed Negm Abdrahman Albany, Nashat Abd El Razek, Magdy BasherDepartment of General Surgery, Mansoura University-Faculty of Medicine, Egypt

Abstract

Background: Timing of cholecystectomy in acute biliary pancreatitis has always been a point of debate among surgeons. Our study has been conducted aiming to compare the safety and efficacy of early versus delayed laparoscopic cholecystectomy in patients with mild acute biliary pancreatitis.

Objective: This study was conducted to compare the benefits and disadvantages of early versus delayed laparoscopic cholecystectomy in patients with mild acute biliary pancreatitis.

Patients and methods: The 96 eligible patients were randomly distributed into two groups, Group I underwent cholecystectomy during index admission, and group II underwent late laparoscopic cholecystectomy 25-30 days after discharge. The operative data were recorded for each patient in special sheets. The patients were followed up for 3 months postoperatively to detect any complications.

Results: 125patients presented with acute biliary pancreatitis between November 2014 and June 2016, 25 patients were excluded because they did not meet inclusion criteria and 4 patients refused to participate in this study. The remaining 96 patients were randomly distributed into 2 groups by computer generated program. Group I (50 patients) underwent cholecystectomy during index admission, group II (46 patients) underwent late laparoscopic cholecystectomy 25-30 days after discharge. There was no statistically significant difference between both groups regarding baseline characteristics including age and sex. The overall hospital stay was significantly lower in group I than group II. No cases in both groups reported to have biliary injuries.

Conclusion: Early laparoscopic cholecystectomy is preferred over delayed laparoscopic cholecystectomy for cases of acute mild biliary pancreatitis because it is associated with faster and easier operation, shorter hospital stay and lower recurrence rate with no significant difference regarding postoperative complications.

INTRODUCTIONAcute pancreatitis is a sudden inflammatory process in the

pancreas which may have an effect on nearby as well as distant organs [1].

The commonest 2 causes of acute pancreatitis are biliary and alcoholism, accounting for more than 80% of acute pancreatitis [2]. It is thought that the passage of a stone through the Ampulla of Vater causes irritation of the pancreatic duct with activation of pancreatic enzymes inside the pancreas [3]. Although the stone itself passes into the duodenum, the damage has been done, and pancreatitis occurs. There is no major difference in the supportive care of biliary and non- biliary pancreatitis [4].

Cholecystectomy remains the definitive treatment for prevention of further attacks of acute gallstone pancreatitis if the person is candidate for surgery [5]. The use of laparoscopic technology for cholecystectomy has become widespread since

the early 1990s. Laparoscopic cholecystectomy became the standard of care for management of gall bladder stones with faster recovery, and lower incidence of intra-operative or post-operative complications if compared to open surgery [6].

The major complications related to laparoscopic cholecystectomy include injury to bile duct (0.3%) [7], and other rare complications such as injury to the bowel, and injury to major blood vessels, resulting in an overall mortality of 0.2% [8].

The appropriate timing of cholecystectomy in acute pancreatitis depends on the clinical course. Patients with severe acute biliary pancreatitis with associated multiple organs dysfunction are, definitely, logical choice for the initial conservative approach with interval laparoscopic cholecystectomy 6-8 weeks later after the resolution of the acute attack. The major determinant in favor of this approach is the fear of added surgical stress to the morbidities associated with severe pancreatitis.

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Recent evidence, with the introduction of laparoscopic surgery, has suggested that patients with mild gallstone pancreatitis, which includes 80% to 90% of all patients with gallstone pancreatitis [9], and do not have any associated organ dysfunction, are candidates to early laparoscopic cholecystectomy during the index admission itself [10]. The most important value for this is to prevent further attacks of acute pancreatitis, seen in as many as 30-50% of these patients during the waiting period for delayed laparoscopic cholecystectomy [11].

Most surgeons agree that timing of the procedure is an important factor in determining prognosis. Debate about the timing of cholecystectomy in patients with acute biliary pancreatitis still exists [12].

AIM OF THE STUDYThis study was conducted to compare between early and

delayed laparoscopic cholecystectomy in patients with mild acute biliary pancreatitis.

PATIENTS AND METHODSThis is a prospective randomized controlled study conducted

at emergency surgery unit, Mansoura University.

All Patients who were admitted to emergency surgery unit, Mansoura University, from November 2014 to June 2016, with the diagnosis of mild acute biliary pancreatitis are potential candidates to participate. Informed written & oral consent was obtained from every patient according to ethical committee of Mansoura faculty of medicine.

Sample selection

After exclusion of cases of sever biliary pancreatitis with Ranson ≥ 3 and patients who did not meet the inclusion criteria, patients with mild acute biliary pancreatitis proved by clinical, laboratory, radiological evaluation and Ranson score < 3 were included in our study after getting an informed consent. Eligible patients re-evaluated clinically, laboratory and radiologically if needed after 48h of hospital admission to confirm that all admitted patients in our study followed these criteria (discharge criteria): the patient could be discharged within 1 or 2 days, no need to give the patient opioid analgesics, C-reactive protein levels decreasing (< 100 mg/l), no local or systemic complications (for example, no fever) and the patient could resume oral intake.

Randomization took place after confirmation and patients randomly divided using computer generated program into two groups (Group I = early group and Group II = late group).

(Group I) were assigned to do early laparoscopic cholecystectomy (within 72 hours of the randomization) while patient still in initial hospital admission regardless of resolution of abdominal pain or normalization of serum pancreatic enzyme levels.

(Group II) with symptoms that settle down completely and all the blood parameters suggestive of pancreatitis to return to normal levels underwent delayed laparoscopic cholecystectomy, 25-30 days after randomization following discharge from initial hospitalization.

Inclusion criteria

Patients with the diagnosis of mild acute biliary pancreatitis with Ranson < 3 at admission and after 48 hrs evaluation, Age ≥ 18 years, American Society of Anesthesiologists (ASA) I & II patients and the patients being admitted to a non-monitored ward bed.

Exclusion criteria

Necrotizing pancreatitis, Pancreatic infected collection, Alcohol abuse or other causes of pancreatitis, ≥ 3 Ranson criteria, Concomitant acute ascending cholangitis, High suspicion for retained common bile duct stone (total bilirubin ≥ 4 mg /dl on admission or ultrasound demonstration of common bile duct stone stone), Pregnancy, need intensive care unit, American Society of Anesthesiologists (ASA) III patients and refusal of participation.

A written informed consent from each patient was obtained before study participation and after full explanation of the technique and its possible complications. The study was approved by our faculty ethical committee.

All patients were informed about their bilio-pancreatic pathology and the suggested treatment according to their diagnosis, Also the possibility of conversion to open.

All cases were operated by dedicated team including senior consultants in our university hospital and a specific operative sheet including adhesions if present and their type fibrinous or fibrous , degree difficulty of Calot dissection, gall bladder wall oedema , and drain inserted or not.

Pre-operative evaluation of the chest radiographs and electrocardiogram studies was performed. Patients’ ASA scores were recorded.

Discharge criteria

Clinical (absence of fever, tolerance of oral feeding and removal of the drain if it was present)

Laboratory: absence of abnormal liver functions or leukocytosis

The patients were followed up in outpatient clinic for 6 months. We have 2 types of complications, early within the admission or within 2 weeks of discharge, late which is up to 6 months.

Statistical analysis of the data

Data were analyzed with SPSS version 21. The normality of data was first tested with one-sample Kolmogorov-Smirnov test.

Qualitative data were described using number and percent. Association between categorical variables was tested using Chi-square test while Fischer exact test was used when expected cell count less than 5.

Continuous variables were presented as mean ± SD (standard deviation and the two groups were compared with Student t test.

Level of significance: For all above mentioned statistical tests done, the threshold of significance is fixed at 5% level (p-value). The results were considered:

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Non-significant when the probability of error is more than 5% (p > 0.05), Significant when the probability of error is less than 5% (p ≤ 0.05) and highly significant when the probability of error is less than 0.1% (p ≤ 0.001).The smaller the p-value obtained, the more significant are the results. Statistical power for operative time was 89 % by using G Power program and effect size was 59%.

RESULTS

Table 1: Demographic characteristics & associated co-morbidities among the studied groups:

Items Measure Early(N=50)

Late(N=46) P

Age(years)

Mean ± SD 38.4 ± 5.1 40.3 ± 5.6^0.214

Range 28.0-48.0 30.0-51.0

SexMale 6 (12.0%) 4 (8.6%)

§1.000Female 44 (88.0%) 42 (91.30%)

DM 2 (4.0%) 3 (6.5%) §1.000HTN 6 (12.0%) 7 (15.0%) §1.000^Independent t-test, §Fisher’s Exact test

Table 2: Admission clinical findings among the studied groups.

Items Measure Early(N=50)

Late(N=46) P

Abdominal pain 50 (100.0%) 46 (100.0%) --Nausea 40 (80.0%) 38 (76.0%) #0.733Vomiting 24 (48.0%) 20 (40.0%) #0.569Jaundice 4 (8.0%) 2 (4.0%) §1.000

Ranson0 18 (36.0%) 20 (40.0%)

#0.7711and2 32 (64.0%) 26 (56.50%)

ASAI 38 (76.0%) 36 (72.0%)

#0.747II 12(24.0%) 10 (21.7%)

Table 3: Preoperative laboratory findings among the studied groups.

Items Measure Early(N=50)

Late(N=46) ^P

Amylase (U/L) Mean ± SD 938.6 ± 447.6 139.26 ± 30.3 <0.001*Lipase (U/L) Mean ± SD 909.5 ± 456.1 75.1 ± 74.3 <0.001*AST (U/L) Mean ± SD 50.24 ± 21.19 47.37 ± 14.21 0.636Total bilirubin(mg/dL) Mean ± SD 1.00 ± 0.37 0.82 ± 0.28 0.069

CRP (mg/dL) Mean ± SD 42.12 ± 13.53 24.39 ± 9.45 <0.001*

Table 4: Intra-operative findings among the studied groups.Early(N=50)

Late(N=46) P

Fibrinous adhesions 14(28.0%) 4 (8.7%) 0.066Gall bladder wall edema 16(32.0%) 6(13.0%) 0.088Fibrous adhesion 10 (20.0%) 34 (73.9%) #0.001*Difficult Calot's triangle dissection 10 (20.0%) 34 (73.9%) #0.001*

Conversion 2 (4.0%) 0 (0.0%) §1.00Drain 32 (64.0%) 30(65.2%) #0.771Morbidity 0 (0.0%) 0 (0.0%) --Operative duration

Mean ± SD 47.7 ± 21.9 60.65 ± 21.1 0.043*

There was statistical difference between both groups regarding recorded intraoperative data. Fibrinous adhesions, gall

bladder wall edema were higher in early group than in late group (p=0.066 and p=0.088, respectively) but without significant statistical difference between both groups due to concomitant acute cholecystitis, the statistical differences were markedly significant only in fibrous adhesion and difficult Calot’s triangle dissection (p=.001in both), operation time was significantly lower in early group than in late group (p=.043).

Table 5: Postoperative hospital stay and Time from discharge to chole-cystectomy.

Findings Measures Early(N=50)

Late(N=46) P

Time from dis-charge to chole-systectomy

Mean ± SD -- 29.8 ± 2.3

Range -- 25.0-33.0

Postoperative hospital stay (days)

Mean ± SD 2.12±0.43 2.17 ± 0.650.736

Range 2-4 2-5

Total legnth of hospital stay (days)

Mean ± SD 5.36 ± .81 8.78 ± 1.00<0.001*

Range 4-6 8-11

^Independent t-test, *Significant

There was no statistical difference between both groups as regard post-operative duration of hospital stay (p=0.736).There was statistically significant difference between both groups regarding total length of hospital stay (p value<0.001).

Table 6: Postoperative complications among the studied groups.

Findings Early(N=50)

Late(N=46) P

Wound infection 2 (4.0%) 4 (8.7%) §1.0

Pseudocyst formation 1 (0.0%) 3 (0.0%) -

Obstructive jaundice 0 (0.0%) 0 (0.0%) --

Cholangitis 0 (0.0%) 0 (0.0%) --

Biliary fistula 0 (0.0%) 0 (0.0%) --

§Fisher’s Exact test

DISCUSSIONThere is no universally accepted definition for ‘early’

laparoscopic cholecystectomy [11]. PONCHO trial [16] suggested index laparoscopic cholecystectomy within the same hospitalization and interval cholecystectomy after discharge from the index admission and we adopted the same concept.

Traditionally, it is felt that patients should recover fully from pancreatitis before cholecystectomy being performed. Surgeons who recommended cholecystectomy 6 weeks after discharge argue that very early cholecystectomy is associated with a more difficult dissection, potentially leading to more conversions and more complications, such as bile duct injuries. They accept the risk of recurrent biliary events, arguing that these can usually be treated by simple cholecystectomy. It has also been suggested that patients should be given time to recover fully from an episode of acute pancreatitis [13].

Classic surgeons are not routinely performing early laparoscopic cholecystectomy after biliary pancreatitis, this can be explained that, early cholecystectomy may have three potential drawbacks: a technically more difficult and demanding

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procedure potentially resulting in more complications; poorer patient condition in early phase; and logistical obstacles [10].

On the other hand, surgeons recommending cholecystectomy during the index admission argue that recurrent biliary pancreatitis may be severe and potentially fatal [14]. Traditionally, early cholecystectomy has been suggested to be technically more demanding than interval cholecystectomy but data to support this statement are lacking. Notably, a recent study found that early cholecystectomy was technically less demanding, which is matching with the nature of peritoneal healing and adhesion formation [15].

The reason for which we waited for reaching the discharge criteria before starting our study is that despite the growing evidence supporting the safety and efficacy of an early LC in the management of mild gallstone pancreatitis, concerns remain with regard to the safety of this approach. In a study by Dambrauskas and his colleagues, they have suggested that from 5% to 10% of patients with presumed mild pancreatitis progress to severe pancreatitis during their hospitalization [17]. A policy of early LC might result in increased morbidity and mortality in a patient misidentified as having mild pancreatitis who then progresses to more severe disease. For that in our study, the matter of timing was established after reaching a stable clinical situation that was described as discharge criteria. It is important to note that, in the present study, no patient with mild pancreatitis progressed to severe pancreatitis. We believe that the safety of an early LC didn’t depend upon timing only, but also on the clinical state.

In a review of more than 59 articles discussing cholecystectomy in the context of gallstone pancreatitis, it was reported that for mild gallstone pancreatitis, laparoscopic cholecystectomy within 48 hours of presentation (without normalization of pancreatic enzymes or absence of abdominal pain) has been shown to shorten hospital stay without increased morbidity or mortality [19]. This was matching with our study as there was significant difference in overall hospital stay of both groups of early and late cholecystectomy.

Several recent studies concluded that interval cholecystectomy carries a substantial risk of recurrent bilio-pancreatic events after discharge and before interval cholecystectomy after mild gallstone pancreatitis [24]. This risk is high even when the interval cholecystectomy takes place within 2 weeks after discharge from the acute pancreatitis [25]. Early cholecystectomy may be indicated to prevent such biliary events, which are associated with patient discomfort, hospital admission and additional costs.

Re-admission rate of 21% has been reported with delayed cholecystectomy group in a study by Cameron and Goodman [26].

In our study, In the 50 patients of the early group (group I), there was no recurrent biliary event in the short interval between the attack of pancreatitis and cholecystectomy. 16 patients out of 46 (34.7%) in the delayed group (group II) had gallstone-related symptoms prior to cholecystectomy. The difference between the two groups is significant (0% vs. 32%, p < 0.002). Ten of the 16 patients (21%) required hospital readmission due to severity of the biliary events. No incidence of cholangitis occurred in our study. The median time between discharge and readmission

is 16 days. The ten admissions occurred within 3 weeks after discharge.

Previously, it was believed that, in the period immediately following the acute attack, the anatomy in the Calot’s triangle is difficult to assess and dissection is both dangerous and difficult. However, our study as well as other studies like Sinha et al. [10], have totally shown different results. It was found that difficult dissection of Calot’s triangle is a phenomenon of delayed surgery. Most of the patients in the early laparoscopic cholecystectomy group had fibrinous omental adhesions where dissection was very easy. In addition the edema in and around the CBD and cystic duct in the initial stages that persists up to seven days makes dissection easier rather than difficult [10]. The most fibrous adhesions is this study was found in delayed group 73.9% causing difficult dissection in these patients. These findings are consistent with the previous report.

Regarding the operative time, in Sinha and co-workers study they have found no effect of timing of surgery on operating time. the duration of surgery was shorter in early group median 80 minutes versus 85 minutes in delayed group but with no significance p=0.752 [10].

Inconsistent with our findings in the present study that has shown that early operation is associated with significantly shorter operative time (47.7 ± 21.9 minutes in Group I versus 60.65 ± 21.1 minutes in group II) (p=0.043).

In our study, early cholecystectomy was associated with early hospital discharge. This is consistent with findings of Sinha et al. [10], Papi et al. [30], in a meta-analysis, consistently, showed a longer hospital stay for patients of interval laparoscopic cholecystectomy group.

In the study of Ammori and his colleagues [27], despite increased age, co-morbidity and more frequent adhesions, their data showed no evidence that intraoperative or postoperative complications were more frequent in patients with biliary pancreatitis underwent early laparoscopic cholecystectomy. They consider that a policy of ‘‘same admission’’ cholecystectomy is appropriate for patients with acute pancreatitis due to gallstones.

Unlike our present study, Bedirli and his colleagues [28] have found that early surgery is associated with significantly higher morbidity rate versus delayed surgery. This can be attributed that they included patients with severe form of disease unlike our study. The operation on patients with severe disease has resulted in mortality rate of 5.1% with early surgery and 4.3% with delayed surgery [28] while in our study there was no mortality.

The possibility of development of postoperative pseudocyst or infected pancreatic necrosis is another factor which has been considered in the literature as a reason for deferring surgery until 6-8 weeks after the attack so interval laparoscopic cholecystectomy advocated in all patients of ABP because of the possibility of a Pseudocyst developing later [29]. But we should remember that mild ABP does not result in any pancreatic necrosis and usually pseudocyst does not form. And even if the pseudocyst develops, the incidence is low and intervention may be required in a smaller percent of these patients and can be carried out laparoscopically [10]. In the present study, pseudocyst

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formation was reported among 4 patients (3 patients of group B and one patient of group A). They were treated conservatively with complete resolution.

None of the operated cases in this study (96 cases) showed post-operative mortality or morbidity except 2 cases (4.0%) in the Group I and four cases (8.7%) in the group II after follow-up period of 6 months .This was in the form of porte site infection and managed by drainage and medical treatment.

In a study by Aboulian and his colleagues, there were no patients in either group that required conversion to open cholecystectomy [18].

In a study by Nebiker and co workers, Conversion to open surgery was necessary in 4 patients (6%) in early group and 2 (3%) in late group; (P = 0.59), the 4 patients of the early group included 3 patients because of severe inflammatory adhesions and difficulties in safe dissection of the infundibulum/cyst duct, and 1 patient because of an injury of the bile duct treated by Roux-en-Y hepatico jejunostomy [20].

In a study by Falor and his colleagues, conversion from LC to open cholecystectomy (2.5% in early LC group versus 7.5% in delayed LC group; P = .80) [21]

In our study, 2 cases in the index group (4%) were converted to open cholecystectomy. All operated cases in the interval group were completed laparoscopically with no conversion to open surgery.

Delayed cholecystectomy is associated with recurrent biliary attacks in 25-61% [22] and delaying cholecystectomy has no advantage regarding intraoperative complications [23].

The current study has supported the evidence that early cholecystectomy is preferred over delayed as it is associated with shorter hospital stay, lower recurrence rate with even better and easier operation due to less adhesions without any increase any postoperative morbidity and this emphasizes the safety and feasibility of early cholecystectomy in patients with mild acute biliary pancreatitis.

CONCLUSIONFrom the present study, the following can be concluded:

1. Laparoscopic cholecystectomy in mild acute biliary pancreatitis is safe and feasible during index admission guided by clinical criteria of improvement (No need for opioid, declining C-reactive protein levels <100 mg/l, No local or systemic complications, patient can resumed oral intake)

2. Early Laparoscopic cholecystectomy in mild acute biliary pancreatitis depending upon clinical guidance not only timing schedule.

3. Early laparoscopic cholecystectomy in mild acute biliary pancreatitis has a comparable least surgical complication in comparison with delayed laparoscopic cholecystectomy.

4. Delayed laparoscopic cholecystectomy in mild biliary pancreatitis carries risk of recurrent biliary events and recurrent re-admission.

5. Laparoscopic cholecystectomy in mild acute biliary pancreatitis has no added risks in comparison with delayed interval laparoscopic cholecystectomy and is recommended in the same admission guided by clinical criteria of improvement (discharge criteria ) not only the issue of definitive time schedule.

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Abou-Sheishaa MS, Burham WA, Abbas AE, Dawoud IE, Shaker MA, et al. (2018) When to do Laparoscopic Cholecystectomy in Mild Acute Biliary Pancreatitis, Early or Late? Ann Emerg Surg 3(1): 1031.

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