An audit of aggressive percutaneous catheter drainage protocol for acute necrotic accumulation in severe acute pancreatitis

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An audit of aggressive percutaneous catheter drainage protocol for acute necrotic accumulation in severe acute pancreatitis

https://doi.org/10.21203/rs.3.rs-2004945/v1

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Aim: To compare the efficacy of proactive percutaneous catheter drainage (PCD) in the treatment of severe acute pancreatitis (SAP) with acute necrotic accumulation (ANC).

Methods: The clinical data of 23 SAP patients with ANC receiving proactive PCD treatment in the single health institution from October 2020 to October 2021 were retrospectively analyzed, compared with 47 patients who receiving standard PCD therapy from September 2018 to September 2020. The indications of PCD were summarized, and the therapeutic effect and drainage situation were compared between the two cohorts.

Results: Betweent the two cohorts, there were no significant differences in demographic data, etiology and severity of pancreatitis, PCD indications and PCD related complications. Patients in the standard PCD cohort had longer hospital stays, more patients requiring ICU care and longer ICU care (P < 0.05). There was no significant difference in the number of persistent organ failure reversals between the two cohorts (78.57% vs 56.00%, P = 0.19), mortality and operative rates. More patients in the proactive PCD cohort had upgraded drains (P = 0.03), had more drains placed (P = 0.048), and had larger drain sizes (P < 0.01). The proactive PCD cohort had higher reduction in APACHEII score (P<0.01), more patency of the drainage tube (P <0.01), and earlier removal of the drainage tube (P = 0.012).

Conlusions: Proactive PCD is an effective way of draining for SAP with ANC.

severe acute pancreatitis

acute necrotic accumulation

percutaneous catheter drainage

Acute pancreatitis is a common gastrointestional disorder and its incidence is on the increase worldwide. As a rapidly progressive disease, severe acute pancreatitis (SAP) has a high mortality rate accompanied with a high incidence of complications, which are life-threatening[1]. Acute necrotic accumulation (ANC) is a common local complication of SAP. Percutaneous catheter drainage (PCD) has become an important means of treatment for severe pancreatitis by which one-third of patients can be cured [2], and the treatment method of actively expanding drainage tube size can improve the clinical recovery rate of SAP patients receiving PCD [3]. In this study, the effect of proactive PCD[4] with periodic expansion of drainage tube size was compared with standard PCD[5] for SAP patients with ANC.

Patients

The retrospective study included the admitted patients who were diagnosed as severe acute pancreatitis (SAP) with acute necrotic accumulation (ANC) from September 2018 to October 2021 to Department of Hepatobiliary Surgery of Daxing Hospital of Xi'an (China). The patients were divided into the following cohorts: ANC receiving proactive PCD (Cohort A) or standard PCD (Cohort B).

Methods

The clinicopathological characteristics of ANC patients were recorded: age, sex, etiology of pancreatitis; Computed tomography Severity Index (CTSI); The severity of the patient's disease; White blood cell (WBC) count at admission. Acute Physiology and Chronic Health Evaluation (APACHE ⅱ) and WBC count before drainage at admission; Number of patients requiring surgical treatment after drainage, duration of hospital stay, number of patients requiring admission to ICU, duration of ICU care, in-hospital mortality; Indications for PCD treatment, number of catheter upgrades, number of new PCD catheter placement, maximum catheter size, total catheter placement time, number of catheter patency, acute physiological and chronic health score 14 days after PCD drainage, number of reversal of sustained organ failure, duration of continuous drainage, PCD related complications (EPF, PCD related bleeding), according to the latest international consensus, three types of organ system dysfunction including respiratory system (PaO2 / FiO2≤300 mmHg), cardiovascular system (requiring positive inotrophilic drugs) and kidney (creatinine ≥171μmol/ L). Organ failure lasting 48 hours or more in the same organ system is defined as persistent organ failure. According to the latest international consensus, External Pancreatic Fistula (EPF) is defined as continuous drainage of more than 100 mL/day of transparent Pancreatic fluid after 3 weeks of PCD.

Treatment

All patients received standardized treatment according to Guidelines for Diagnosis and Treatment of Acute Pancreatitis (2014) [6], with the basic purpose of maintaining hemodynamic stability of patients. Standard management in all the patients included fluid resuscitation, organ support, pain relief, and nutritional support. Contrast-enhanced computed tomography (CECT) of the abdomen was performed between 5 and 7 days after the pain onset. Antibiotic administrationwas indicated for extrapancreatic infections and suspected infection of the pancreatic necrosis (based on the presence of gas within the collection or worsening of patients’ clinicalcourse). The PCD fluid was sent for culture to establish the infection and guide further antibiotic therapy based on the sensitivity results.

PCD procedure

The initial access to the collection was obtained using an 18 G needle and 0.035″ stiff guide wire. The entry tract was dilated with fascial dilators. The catheter (either pigtail or Malecot catheter) was later placed over the guidewire. The catheter was secured in place using a suture. The initial size of the drainage tube is 10Fr [7], flushing of PCD was done using normal saline (50–100 mL) at the bedside at least once daily. Besides, the interventional radiologist irrigated the catheter with the same volume of normal saline at the time of evaluation of patients. The catheter exchanges and upgradations were performed under USG guidance or fluoroscopy. Patients who failed to recover with PCD were subjected to minimally invasive surgical necrosectomy.

The improvement of organ failure, control of infection and relief of stress symptoms were monitored after surgery. If there is no improvement within 72 hours, a larger tube is replaced until 16 Fr or a new tube is inserted for better drainage.

Extubation indication: clinical symptoms improved, drainage fluid < 10mL/d for 5-7 days; CT reexamination indicated that the necrotic tissue of pancreas disappeared basically. Amylase in drainage fluid < 100U/L; The drainage tube can be removed in patients with negative bacterial culture of drainage fluid.

Proactive PCD

The proactive PCD was defined as PCD drainage was performed on all areas of necrosis and exudate accumulation in patients with drainage indications. This approach involved: (1) upsizing (every4–6 days) to drain the entire collection, including both the liquid and the necrotic component. Following the first PCD (14F), catheter upsizing was done every fourth to sixth day (with an increment of 2–4Fin the caliber of the catheter). The maximum catheter size was 28F. (2) The indications of a new PCD were: a new collection (not present on imaging that was done before or at the time of the first PCD) or significant extension of the collection to a different abdominal compartment.

Stardard PCD

Following the first PCD (10F), catheter upsizing was performed only when there was a lack of improvement or deterioration in patients’ condition, and the CT scan showed a significant residual collection or a new collection. The maximum catheter size used in this protocol was 16F. The indication and method of catheter removal were the same as the pro-active cohort.

Statistical analysis

Statistical analysis was done using SPSS version 20 for Windows (Armonk, NY).The results were presented as mean ± standard deviation (±SD) or proportion according to types of variables, continuous variables were statistically analyzed by T test of independent samples. Chi-square test was used for comparative analysis of categorical variables, and Fisher's exact probability method was used for comparative analysis of categorical variables of small samples. All analyses were based on two-sided test, and P <0.05 was considered statistically significant.

Baseline Characteristics

The present study included total 70 eligible e patients admitted to Department of Hepatobiliary Surgery of Daxing Hospital of Xi'an from September 2018 to October 2021. The Cohort A comprised 23 cases, of whom 10 were male and 13 were female, with a mean age of 55.74±14.71 years. The Cohort B comprised 47 cases, of whom 28 were male and 19 were female, with a mean age of 50.60±14.22 years.

The following parameters were comparable between the two cohorts: etiology, CTSI, APACHE ⅱ score at admission and preoperative WBC count (Table 1).

Outcome of PCD

There was no significant difference in the proportion of patients requiring surgical treatment after PCD drainage between the two cohorts, The but cohort B had longer hospital stays, required more ICU care with longer ICU care (P < 0.05) (Table 1).

Mortality was similar between the two cohorts. In the Cohort A, 3 patients died: (pancreatic encephalopathy, transverse colon fistula and respiratory dysfunction due to respiratory tract infection complicated with chronic obstructive pulmonary disease (COPD), respectively. In the Cohort B, 6 patients died, including gastrointestinal fistula(2 cases 1 complicated with multiple organ failure), duodenal fistula(1), 1 pancreatic fistula died of acute respiratory distress syndrome (ARDS)(1), abdominal bleeding (1 ,pancreatic encephalopathy(1) and severe pneumonia complicated with multiple organ failure(1), respectively.

Table 1

Baseline Characteristics of Patients with Infected and Symptomatic Sterile WON

Parameter		Total （n=70）	Proactive PCD cohort （n=23）	Standard PCD cohort（n=47）	t/χ2 value	P
Age (years, x±s)		52.29±14.48	55.74±14.71	50.60±14.22	1.41	0.16
Gender (female) [Cases (%)]		29（41.43）	10（43.48）	19（40.43）	0.06	0.81
Etiology [cases (%)]
	Alcohol	21（30.00）	7（30.43）	14（29.79）	0.003	0.96
	Biliary	27（38.57）	9（39.13）	18（38.30）	0.005	0.95
	Idiopathic	13（18.57）	4（17.39）	9（19.15）	-	1.0
	Other reasons	9（12.86）	3（13.05）	6（12.77）	-	1.0
CTSI（x±s）		9.18±1.93	9.26±2.12	8.89±1.89	0.74	0.46
Admission APACHE ⅱ (score, x±s)		15.00±3.11	15.48±3.00	14.77±3.16	0.90	0.37
WBC count（×10⁹/L）（x±s）		15.42±3.73	15.45±3.92	15.40±3.67	0.06	0.96
Surgical treatment was required [cases (%)]		16（22.86）	3（13.04）	13（27.66）	-	0.17
Length of hospital stay (days, x±s)		30.73 ± 7.41	28.91 ± 5.05	32.32 ± 6.95	-2.09	0.04
ICU monitoring required [cases (%)]		32 （45.71%）	6 （26.09）	26（55.32%）	5.32	0.02
Duration of ICU care (days, x±s)		11.79± 4.74	8.00 ± 2.19	12.26 ± 4.81	-2.10	0.04
Death in hospital [cases (%)]		9（12.86）	3（13.04）	6（12.77）	-	1.00

CTSI: computed tomography severity index）; APACHE: Acute Physiology and Chronic Health Evaluation; ICU: intensive care unit

There was no significant difference in APACHE II scores between the two cohorts on admission. After two weeks of PCD drainage, APACHE II scores in the cohort A were significantly lower than those in the cohort B, and the APACHE II scores decreased more significantly. There was a remarkable reversal of persistent organ failure in both cohorts, but no significant difference was observed in the reversal rateor new occurrence of organ failure between two cohorts (Table 2).

Indications of PCD and treatment parameters

PCD was indicated by symptoms of suspected infection necrosis, persistent organ failure, and compression. The most common indication of PCD in ANC patients was persistent organ failure (55.71%), followed by suspected infection (34.29%) and compression symptoms (10%). More patients in the cohort A had their drainage tubes upgraded (P = 0.03), more new drainage tubes were placed, and the maximum drainage tube size was significantly larger in the cohort A than in the cohort B(P < 0.001). Compared with the cohort A, the drainage tube lasted longer in the cohort B (P = 0.012) and was more easily blocked (P < 0.01) (Table 2).

Complications of PCD

There was no significant difference in PCD-related complications between the two cohorts. External pancreatic leakage (EPF) was the most common complications (18 cases), and 6 patients had PCD-related bleeding.

Table 2

PCD parameters and efficacy of the proactive cohort and the standard cohort

Parameters			Total （n=70）		Proactive PCD cohort （n=23）		The standard PCD cohort （n=47）		t/χ2 value		P
PCD indication [cases (%)]
		Suspected infection		24（34.29）		7 (30.43)		17 (36.17)		0.23		0.64
		Persistent organ failure		39（55.71）		14 (60.87)		25(53.19)		0.37		0.54
		oppression symptoms		7（10.00）		2 (8.70)		5(10.64)		-		1.00
	Upgrade PCD [case (%)]			36（51.43）		16 （69.57）		20 （42.55）		4.51		0.03
	Place new PCD [case (%)]			28（40.00）		13（56.52）		15（31.91）		3.90		0.048
	PCD maximum catheter (Fr, x± S)			15.06± 4.62		19.30± 4.82		12.98± 2.72		7.02		<0.01
	Days of continuous drainage (days, x±s)			24.96 ± 6.45		22.22 ± 5.49		26.30 ± 6.51		-2.59		0.012
Catheter patency [root (%)]			91 (87.50)		43 (100)		48 (78.69)		-		0.001
APACHE II admission (A) (score, x±s)			15.00±3.11		15.48±3.00		14.77±3.16		0.90		0.37
APACHE II PCD drainage after 14 days (B) (分, x±s)			9.17 ± 2.69		7.78 ± 2.09		9.85 ± 2.70		-3.23		0.002
APACHE II reduced values (A-B) (分, x±s)			5.80 ± 2.63		7.70 ± 2.06		4.87 ± 2.38		4.86		<0.001
** Number of reversals of persistent organ failure [cases (%)]			25/39 (64.10)		11/14 (78.57)		14/25 (56.00)		-		0.19
EPF [case（%）]			18 (25.71)		5 (21.73)		13（27.66）		0.28		0.59
PCD related bleeding [case（%）]			6 (8.6)		2 (8.70)		4 (8.51)		-		1.00

* A total of 104 drainage tubes were placed, 43 tubes in the proactive PCD cohort and 61 tubes in the standard cohort.

There were 39 patients with persistent sexual organ failure, and 14 patients in proactive PCD cohort and 25 cases in the standard PCD cohort.

This retrospective study compared the efficacy of proactive PCD in in 23 patients of SAP with ANC versus the standard PCD in 47 patients. Proactive PCD strategy includes changing larger diameter drainage tubes and placement of new drainage tubes frequently to facilitate adequate drainage of necrotic tissue. In the treatment process, we found that the proactive PCD procedure was easy for clinical operation. Compared with the standard PCD drainage procedure, patients treated by the proactive PCD procedure had a higher reduction in APACHE II score, shorter hospital stay, less ICU admission, shorter monitoring time, less blockage of the lumen, and earlier drainage tube removal.

Nearly 90% of patients with severe acute pancreatitis (SAP) will develop into ANC[8]. Previously, necrosectomy was the main treatment regimen for patients who was failed to conservative treatment [9]. Modern surgical treatment of ANC is guided by the concept of step up treatment, characterized by minimally invasive, and multi-disciplinary staged treatment. Compared with open surgery, minimally invasive step-up surgery can reduce the in-hospital death of critical patients [10]. The " Step-up Approach " has become the preferred option for ANC patients. Moreover, 35-70% [11] of ANC patients can be cured by catheter drainage alone, without the need to step up to minimally invasive surgery.

Since Freeny et al [12] firstly described the role of percutaneous catheter drainage in the treatment of moderate - severe acute pancreatitis, PCD has been increasingly used in the treatment of severe acute pancreatitis. In ANC patients, PCD is an integral part of the “Step-up Approach” [13], but the standard PCD drainage has some weakness such as inadequate drainage, easy blockage of drainage tube, and reset of the drainage tube for several times. In this method, a 10-12F catheter is placed under ultrasound or CT guidance to passively drain necrotic material. After several days of PCD drainage, if the patient's clinical symptoms did not improve, surgical removal of necrotic tissue was advanced. Because standard PCD method cannot adequately drain heterogeneous liquid and solid mixtures [5], Pankaj et al proposed the proactive PCD method [4]. The methods include: proactive PCD drainage; replacing the drainage tube regularly; progressively replacing the thicker drainage tube and actively dousing the drainage tube to effectively drain the necrotic material. Compared with standard PCD, this method has been shown to reduce mortality and surgical necrotic tissue clearance without an increase in patients with PCD related complications.

Since PCD can enter the necrotic area via the peritoneum or retroperitoneum, the drainage path is more flexible. However, proactive PCD method not only has variable drainage pathway, but also has larger diameter, which is more conducive to the drainage of necrotic tissue and can avoids the issue of drainage tube blockage. Sugimoto et al [14] performed CT scan every 3 days after the first placement of 12F catheter, and PCD tube angiography was performed after each CT to confirm the patency of drainage tube. Per standard PCD, based on the CT results, a larger diameter catheter is replaced and a new catheter is inserted, but it leads to more radiation exposure.

In the study of Van Grinsven et al [15], PCD was only used for patients with suspected or confirmed infection, and catheter enlargement was not performed at fixed time intervals. Compared with the previous method, the most common indication of PCD in our proactive PCD method was persistent organ failure (55.7%), followed by suspected infection (34.3%) and compression symptoms (7%). Every 4 to 6 days, a larger diameter catheter was placed through the primary sinus tract under ultrasound guidance rather than routinely CT and angiography; Both the initial catheter size (14F) and maximum catheter size (28F) were larger than those in previous studies. This makes the procedure more practical and clinically acceptable without increasing medical costs and suitable for drainage in ANC patients. In addition, proactive PCD inserts more drainage tubes, which can form a "drainage system" and expand the range of continuous active drainage. It is also possible to inject lavage fluid through one or more catheters and drain it out through other drainage tubes. In a word, compared with standard PCD method, proactive PCD method has more advantages.

Our study demonstrated that the proactive PCD method is an effective option for SAP with ANC and is easily to perform in clinical practice. It improves ANC-related organ failure, providing clinical benefit to patients without additional risk. However, due to the small sample size and single institution experience of this retrospective study, well designed random trials are still needed to confirm whether the proactive PCD can reduce the mortality and rate of necrosectomy in ANC patients.

- Ethics approval and consent to participate

Patients diagnosed with severe acute pancreatitis (SAP) with acute necrotic accumulation were retrospective study enrolled at the Department of Hepatobiliary Surgery, a care centre in China. The study was approved by the Daxing Hospital of Xi’an Medica ethics committee. The informed consent of some patients has been obtained before enrollment, and the remaining patients could not be contacted. With the consent of the Medical Ethics Committee of Xi'an Daxing Hospital, the informed consent of these patients was waived. (See attachments)

All enrolled patients were older than 16 years. It is hereby stated that all methods of this retrospective study were performed in accordance with the relevant guidelines and regulations (for example- Declarations of Helsinki) .

-Consent for publication

NOT APPLICABLE

-Availability of data and materials

The datasets used and/or analysed during the current study available from the corresponding author on reasonable request. [its supplementary information files].

-Competing interests

This article does not have any Competing interests

-Funding

Corresponding authors M.D. Hong-jun XIANG provided funding for this study.

-Authors' contributions

Junqiang DANG and Qingqiang WANG provided and collected patient information. Yanling YANG and Junqiang DANG collected and analyzed the data. Tingshun ZHU and Lin SHANG took care of the patients. Jianbing SUN and Jianxin DONG participated in treatment plans. Lei ZHU，Yanling YANG and Hongjun XIANG helped with revising the manuscript. Zhilin YUAN and Hongjun XIANG wrote the paper. All authors contributed to the article and approved the submitted version.

-Acknowledgements

We thank Professor Yanling YANG of the Department of Hepatobiliary and Pancreatic Surgery, Xijing Hospital, Air Force Medical University, for providing surgical guidance. We thank the patients for allowing us to share their medical history and clinical course.

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No competing interests reported.

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An audit of aggressive percutaneous catheter drainage protocol for acute necrotic accumulation in severe acute pancreatitis

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