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LBR-2014-endoscopy-胰腺结石eswl并发症

submitted:18.March2014 accepted after revision:

2.July2014

Bibliography

DOI https://www.wendangku.net/doc/b27475303.html,/

10.1055/s-0034-1377753 Published online:2014 Endoscopy

?Georg Thieme Verlag KG Stuttgart·New York

ISSN0013-726X Corresponding author Liang-Hao Hu,MD

or Zhao-Shen Li,MD Department of Gastroenterology

Digestive Endoscopy Center Changhai Hospital

The Second Military Medical University

168Changhai Road Shanghai200433

China

Fax:+86-21-55621735

lianghao-hu@https://www.wendangku.net/doc/b27475303.html, zhaoshen-li@https://www.wendangku.net/doc/b27475303.html, Introduction

!

Intracanalar or intraductal stones are pathogno-

monic signs of chronic pancreatitis and occur in

approximately90%of patients with this long-

standing disease.These stones further obstruct

the outflow from the pancreas,leading to recur-

rent attacks of pancreatitis and abdominal pain.

Endoscopic retrograde cholangiopancreatogra-

phy(ERCP),the primary method used to elimi-

nate pancreatic stones,fails to treat more than

half of the patients with chronic pancreatitis

bearing pancreatic stones[1].As such,extracor-

poreal shock wave lithotripsy(ESWL)has been

developed to treat pancreatic stones when rou-

tine endotherapy cannot be applied effectively

[2].

In pancreatic ESWL(P-ESWL),impacted stones in

the pancreas are fractured or loosened;stone

clearing is then achieved either spontaneously or

via ERCP[3,4].This procedure was first used to

remove pancreatic stones in1987;since then,P-

ESWL has been safely and effectively applied[2,

5–9].However,a few patients may suffer from

adverse events caused by related stone fragments

and injury to the tissues surrounding the pan-

creas.Given the lack of established definition and

classification for the adverse events of P-ESWL,

the reported prevalence varies from0%to20%

[10].The adverse events include skin erythema,

hematuria,post-ESWL pancreatitis,bleeding,and

perforation[5–7,11–16].Several of these ad-

verse events are mild and transient,and do not

require medical intervention,whereas other con-

*Drs.Li,Liao,and Du contributed equally to this study.

Background and study aims:Extracorporeal shock

wave lithotripsy is recommended as treatment

for stones in chronic pancreatitis.The aim of this

study was to investigate the risk factors for com-

plications of pancreatic extracorporeal shock

wave lithotripsy(P-ESWL).

Patients and methods:Patients with painful

chronic pancreatitis and pancreatic stones(>5

mm diameter)who were treated with P-ESWL

between March2011and June2013were pro-

spectively included.Adverse events after P-ESWL

were classified as complications and transient ad-

verse events,depending on severity.The major

complications of P-ESWL included post-ESWL

pancreatitis,bleeding,infection,steinstrasse,and

perforation.Multivariate analyses based on uni-

variate analysis were performed to detect risk fac-

tors of overall and moderate-to-severe complica-

tions.

Results:A total of634patients underwent1470

P-ESWL procedures.The overall complication

rate was6.7%of all https://www.wendangku.net/doc/b27475303.html,plications oc-

curred in62patients(9.8%)after the first ESWL

procedure.The risk factors for complications

were pancreas divisum(odds ratio[OR] 1.28)

and the interval between diagnosis of chronic

pancreatitis and P-ESWL(OR1.28).Protective fac-

tors were male sex(OR0.50),diabetes(OR0.45),

and steatorrhea(OR0.43).Male sex,the only

identified predictor for moderate-to-severe com-

plications,was a protective factor(OR0.19).For

the second P-ESWL procedure,complications oc-

curred in22/409patients(5.4%).Complication

and asymptomatic hyperamylasemia after the

first ESWL session were significantly associated

with higher risk for complications after the sec-

ond ESWL session(P<0.05).

Conclusions:Patient-related factors were impor-

tant in determining a high risk of P-ESWL compli-

cations when no procedure-related factors were

identified.Patients suffering from complications

after the first ESWL session were also likely to ex-

perience complications in subsequent P-ESWL

sessions.

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ditions need specific medical treatment or prolonged hospitali-zation and may even be considered as life threatening [14,16].Therefore,adverse events should be classified and risk factors should be identified to improve the safety of P-ESWL.

The aim of this prospective study was to identify the risk factors associated with the development of adverse events in P-ESWL.

Patients and methods

!

This prospective observational study was performed at a tertiary referral center.All patients with chronic pancreatitis who were treated with P-ESWL for pancreatic stones between March 2011and June 2013at Changhai Hospital were included.Written in-formed consent was obtained from each patient.The study was approved by the Ethics Committee of Changhai Hospital.

Patients

The diagnosis of chronic pancreatitis was established according to the Asia-Pacific consensus [17].P-ESWL was performed in pa-tients suffering from painful chronic pancreatitis with at least one large pancreatic stone (>5mm in diameter).Patients with previous ERCP or pancreatic surgery for chronic pancreatitis were also considered for inclusion in the study.Patients with isolated pancreatic tail stone,suspected or established malignan-cy,pancreatic ascites,and pregnancy were excluded.Patients with cholangitis,resulting from common bile duct (CBD)stric-tures secondary to chronic pancreatitis,were treated with P-ESWL after cholangitis had subsided.

Classification of adverse events

An adverse event of P-ESWL is an undesired harmful event,and was classified as either a complication or a transient adverse event (TAE),depending on severity.To date,no firm definition of a severe adverse event or complication of P-ESWL has been es-tablished.In the current study,complications were recognized as adverse events needing specific medical intervention and pro-longed hospitalization.Based on published studies [5–7,11–16]and our clinical experience [18],major complications were classi-fied into five groups (post-ESWL pancreatitis,bleeding,infection,steinstrasse,and perforation).Steinstrasse was defined as acute

stone incarceration in the papilla that leads to poor pancreatic juice drainage,and computed tomography (CT)findings of dila-ted pancreatic duct with/without acute pancreatitis [18].Severe abdominal pain caused by steinstrasse that cannot be relieved by analgesics should be relieved by emergency ERCP or ESWL.In re-ference to the ERCP complication classification [19],P-ESWL complications were also stratified as mild,moderate,or severe depending mainly on the length of hospitalization and the need

for invasive treatment (●

Table 1).Splenic rupture,pancreatico-biliary fistula,and other rare complications were not included in this classification.In addition to complications,TAEs referring to mild adverse events were proposed.TAEs were defined as transi-ent injuries caused by shock waves,which required no medical intervention and did not prolong hospitalization.TAEs included skin erythema,mild tenderness of the region in contact with the shockwave head,asymptomatic hyperamylasemia,hematuria,and acute gastrointestinal mucosal injury (manifested as hema-temesis and melena).Asymptomatic hyperamylasemia was de-fined as an increase in serum amylase compared with pre-ESWL levels and beyond the upper limit of the normal range but show-ing no related symptoms.

P-ESWL procedure

P-ESWL was performed by two gastroenterologists (L.H.H.and B.Y)using an electromagnetic lithotripter (Compact Delta II;Dor-nier Med Tech.,Wessling,Germany)with bi-dimensional fluoro-scopic targeting facility.The pretreatment procedure was similar to that for ERCP.Intravenous remifentanil combined with flurbi-profen was administered for analgesia during the procedure.Be-fore P-ESWL was started,50mg flurbiprofen was intravenously infused,and continuous remifentanil infusion (initial concentra-tion 12μg/h·kg)was started.The concentration of remifentanil was slightly adjusted according patient assessment of pain (on a visual analog scale)and breathing rate.During the procedure,an-other 50mg flurbiprofen was administered if the patient com-plained of gradually intensifying pain.

Patients were placed in the supine position or were tilted to their

right side at an angle of 30°(●

Fig.1).The 30°-right supine posi-tion may facilitate effective contact with the shockwave head and avoid the vertebrae and stones from overlapping in the image.Stones were directly targeted fluoroscopically in patients

with

Table 1Definitions of major complications of pancreatic extracorporeal shock wave lithotripsy.

ESWL,extracorporeal shock wave lithotripsy.1

Splenic rupture,pancreaticobiliary fistula,and other rare complications were not included in this classification of complications.2

Acute gastrointestinal mucosal injury was not included,but was classified as a transient adverse event.3

Steinstrasse [18]:acute stone incarceration in the papilla leading to poor pancreatic juice https://www.wendangku.net/doc/b27475303.html,puted tomography shows a more dilated pancreatic duct with/without acute pancreatitis.Severe abdominal pain that cannot be relieved by analgesics could be relieved by emergency endoscopic retrograde cholangiopancreatography or ESWL.

D o w n l o a d e d b y : I P -P r o x y U n i v e r s i t y o f C h i c a g o , U n i v e r s i t y o f C h i c a g o . C o p y r i g h t e d m a t e r i a l.

opaque stones.For patients with radiolucent stones,a nasopan-creatic tube was inserted after pancreatic sphincterotomy to fa-cilitate fluoroscopic targeting during P-ESWL.The exposure was limited to a maximum of 5000shock waves per session.An inten-sity ranging from 1to 6was used with a frequency of 60–120shocks per minute during the procedure.The duration of each session was 60–90minutes.The fragmentation of the stones was monitored by fluoroscopy during the P-ESWL session.

Repeat P-ESWL sessions were performed over consecutive days until the stones had been fragmented to 3mm or less in size.For patients with P-ESWL complications,the next P-ESWL session was recommended when the patient had recovered from compli-cations.Although it was agreed that ESWL alone is a more cost-effective strategy than ESWL combined with ERCP for selected patients [3,20],ERCP was routinely performed in the current study after the last P-ESWL session,in order to remove stone fragments and complete the visualization of the pancreatic duct system.Pancreatic stents (5–10Fr)were inserted for patients with dominant main pancreatic duct (MPD)stricture,MPD rup-ture,or pseudocyst that necessitated stent placement for drain-age [20].

Data collection

The following data were prospectively recorded:demographic data (age,sex,height,and weight),course and medical history of chronic pancreatitis and other diseases,smoking and alcohol sta-tus,disease history of family members,and characteristics of pancreatic stones (number,location,and distribution).Previous treatments (endoscopic papillotomy,pancreatic stent,CBD stent,etc.)were also recorded.P-ESWL procedure-related information,including the location,number,and size of targeted stones,ener-gy level,pressure of water capsule,shockwave frequency,num-

ber of shock waves,and the number of P-ESWL sessions,was col-lected in detail.The characteristics of the MPD were evaluated based on CT,magnetic resonance imaging,endoscopic ultra-sound,and/or previous ERCP (post-P-ESWL ERCP when needed).The complications and TAEs of P-ESWL were recorded in detail.Delayed complications were also collected during the 1-month follow-up period after discharge.The treatment for each compli-cation was recorded.Skin erythema and mild tenderness from contact with the shockwave head were not analyzed because these adverse events were observed in almost all of the patients.

Data analysis

For patients undergoing more than one P-ESWL session,only the first procedure was included in the analysis of risk factors.The potential risk factors of P-ESWL adverse events are listed in detail in ●

Table 2.Continuous variables were assessed using t test or nonparametric Mann –Whitney U test as indicated in the uni-variate analysis.Continuous variables were also transformed to categorical variates (ordinal variates when needed)based on prior studies and clinical experience.Chi-squared analysis or Fisher ’s exact test was used for categorical variables.A logistic re-gression model was used for multivariate analysis to identify the independent risk factors for P-ESWL complications,moderate or severe (moderate-to-severe)complications,post-ESWL pancrea-titis,and TAEs.Odds ratios (ORs)and 95%confidence intervals (CIs)were calculated.Statistical analyses were conducted at a sig-nificance level of 0.10for univariate analysis and 0.05for multi-variate analysis.Data were analyzed using SPSS 18.0(SPSS,Chica-go,Illinois,USA).

D o w n l o a d e d b y : I P -P r o x y U n i v e r s i t y o f C h i c a g o , U n i v e r s i t y o f C h i c a g o . C o p y r i g h t e d m a t e r i a l.

Results

!

A total of 634consecutive patients who underwent 1470ESWL procedures were included in the study.The mean number of P-ESWL sessions and number of shock waves per patient were 2.3sessions and 11640shock waves,respectively.The general char-acteristics of patients are listed in ●

Table https://www.wendangku.net/doc/b27475303.html,plications oc-curred in 99procedures (●

Table 4).One procedure resulted in complications of moderate post-ESWL pancreatitis and mild bleeding (hematoma in the hepatic portal)and was classified as a moderate complication.A total of 16procedures caused moder-ate-to-severe complications.No other rare complications were observed with the exception of pancreas fistula in one patient.One patient with hepatic subcapsular hematoma was treated with percutaneous hematoma drainage.Other patients suffering from complications recovered under close observation and con-servative medical treatment.Overall,the P-ESWL complication rate was 6.7%,and the prevalence of moderate-to-severe compli-cations was 1.1%of the 1470P-ESWL procedures.

For the first P-ESWL sessions,62patients (9.8%)experienced

complications (●

Table 4).Post-ESWL pancreatitis was the most common complication,with an occurrence rate of 6.8%and ac-counting for 69.4%of complications.

Risk factors for complication

All of the potential risk factors were assessed by univariate anal-ysis and 10factors were significantly related to P-ESWL compli-cations (●

Table 5).These 10factors were included in the binary logistic regression analysis.The results showed that five factors were independent predictors of P-ESWL complications.The inde-pendent predictors included protective factors such as male sex,diabetes,and steatorrhea as well as the risk factors of

pancreas

Table 2Potential predictors of pancreatic extracorporeal shock wave lithotripsy complications involved in risk factor analysis.

CBD,common bile duct;ESWL,extracorporeal shock wave lithotripsy;SAP,severe acute pancreatitis;MPD,main pancreatic duct;HCP,heredity chronic pancreatitis;ERCP,endoscopic retrograde cholangiopancreatography;EPT,endoscopic papillotomy.1

Diagnosis standard of alcoholic chronic pancreatitis was used to present the alcohol consumption as a binary categorical factor.2

Patients with first-degree relative(s)with chronic or recurrent acute pancreatitis were diagnosed as HCP.3

This measure indicates the distance between the shock wave head and targeted

stone.

Table 3Patient characteristics in the study.

P-ESWL,pancreatic extracorporeal shock wave lithotripsy;ACP,alcoholic chronic pancreatitis;ICP,idiopathic chronic pancreatitis;CBD,common bile duct;ERCP,endoscopic retrograde cholangiopancreatography.1

Repeated abdominal pain attacks without a significant increase in serum amylase.

D o w n l o a d e d b y : I P -P r o x y U n i v e r s i t y o f C h i c a g o , U n i v e r s i t y o f C h i c a g o . C o p y r i g h t e d m a t e r i a l.

divisum and longer interval between diagnosis of chronic pan-creatitis and P-ESWL.

Risk factors for moderate-to-severe complication

Only 11patients suffered from moderate-to-severe complica-tions after the first P-ESWL session.Logistic regression analysis involved four potential risk factors determined by univariate analysis.Male sex was identified as an independent protective

factor associated with moderate-to-severe complications (●Ta-ble 6).

Risk factors for post-ESWL pancreatitis

In the analysis of the risk factors for post-ESWL pancreatitis,the patients suffering from complications other than post-ESWL pan-creatitis were excluded.Patients without P-ESWL complications were set as the control group.Among the included potential risk factors,10were significantly different between patients with and without post-ESWL pancreatitis.Logistic regression analysis re-sults showed that four patient-related factors were independent-ly associated with post-ESWL pancreatitis:male sex and

steator-

Table 4Complication frequency and severity of extracorporeal shock wave lithotripsy.

P-ESWL,pancreatic extracorporeal shock wave lithotripsy.1

One procedure resulted in both moderate post-ESWL pancreatitis and mild bleeding (hematoma in the hepatic portal),which were classified as a moderate

complication.

Table 5Risk factors for the complications of first extracorporeal shock wave lithotripsy in univariate and multivariate analyses.

P-ESWL,pancreatic extracorporeal shock wave lithotripsy;CI,confidence interval.1

Control group were patients without complications after the first P-ESWL session.

D o w n l o a d e d b y : I P -P r o x y U n i v e r s i t y o f C h i c a g o , U n i v e r s i t y o f C h i c a g o . C o p y r i g h t e d m a t e r i a l.

rhea were protective factors,and pancreas divisum and frequent

attacks of acute pancreatitis were risk factors (●

Table 7).Risk factors of TAE

TAE after P-ESWL was not evaluated in the 154ESWLs proce-dures (78patients)performed before July 2011.In the 1316pro-cedures with TAE evaluation,279(21.2%)showed TAE-positive

results (●

Table 8).Asymptomatic hyperamylasemia was ob-served in 15.5%of 1316P-ESWLs.The occurrence rate of hema-turia was 4.2%.

In the first ESWL procedures,the number of patients with TAE

was 142/514(27.6%)(●

Table 9).Patients suffering from both complications and TAE from the first P-ESWL session were not in-cluded in the analysis of TAE risk factors.The details of specific

TAEs are presented in ●

Table 8.In all,15factors were signifi-cantly different between TAE and control groups in the univariate analysis.To avoid including overlapping variates in the multivari-ate analysis,only 11of the 15variates were included in the logis-tic analysis.Five protective factors (diabetes,steatorrhea,pre-vious ERCP,needing further P-ESWL,multiple-location of targe-ted stones)and two risk factors (acute pancreatitis attack in

3

Table 6Risk factors of moderate-to-severe complications of first extracorporeal shock wave lithotripsy in univariate and multivariate analyses.

CI,confidence interval.1

Control group were patients without moderate-to-severe complications after the first pancreatic extracorporeal shock wave lithotripsy

session.

Table 7Risk factors of post-extracorporeal shock wave lithotripsy (ESWL)pancreatitis of the first ESWL session in univariate and multivariate analyses.

CBD,common bile duct;P-ESWL,pancreatic extracorporeal shock wave lithotripsy;CI,confidence interval.1

Control group were patients without complications after the first P-ESWL session (19patients with complications other than post-ESWL pancreatitis were excluded from the con-trol

group).

Table 8Transient adverse events as frequency of the total extracorporeal

shock wave lithotripsy sessions and the first session only.

TAE,transient adverse event;P-ESWL,pancreatic extracorporeal shock wave lithotripsy.1

A total of 295TAEs referred to 279procedures.2

A total of 152TAEs referred to142procedures in the 514first P-ESWL session.

D o w n l o a d e d b y : I P -P r o x y U n i v e r s i t y o f C h i c a g o , U n i v e r s i t y o f C h i c a g o . C o p y r i g h t e d m a t e r i a l.

months,pseudocyst in chronic pancreatitis course)were detect-ed (●

Table 9).Complications of the second P-ESWL session

Among the 634patients undergoing ESWL,409were treated with more than one P-ESWL session.For the second P-ESWL ses-sion,complications were observed in 22patients (5.4%).Among these patients,three were classified as having moderate-to-se-vere complications.The complication rate for the second P-ESWL session was lower than that for the first session.Moreover,among the 22patients,five patients had suffered from complica-tions in the first session.Post-ESWL pancreatitis was the most re-peated event.The association of adverse events from the first P-ESWL session and those from the second session was assessed ●

Table 10).Post-ESWL pancreatitis and asymptomatic hypera-mylasemia after the first session were significantly associated with a higher risk of complications following the second P-ESWL session.

Discussion

!

Adverse events in urinary ESWL have been classified [21],and studies have focused on the risk factors of ESWL-related compli-cations [22,23].In P-ESWL,which has been clinically applied to the fragmentation of pancreatic stones since 1987,no specific studies on the complications of P-ESWL and related risk factors have been reported.In this prospective study,the adverse events of P-ESWL were described in detail in terms of complications and TAEs.Several risk factors were found.The overall complication and TAE rates were 6.7%and 21.2%,respectively.Considering the first P-ESWL sessions,the complication and TAE rates were 9.8%and 27.6%,respectively.

Diabetes and steatorrhea,which are caused by serious insuffi-cient endocrine/exocrine pancreas functions,are protective fac -tors for P-ESWL complications.The relatively lower complication rate may be attributed to the damage in the pancreas from chron-ic pancreatitis as shown in post-ERCP complications [24].How-ever,the results also showed that the intervals between the

onset

Table 9Risk factors of transient adverse events of the first pancreatic extracorporeal shock wave lithotripsy session in univariate and multivariate analyses.

P-ESWL,pancreatic extracorporeal shock wave lithotripsy;ERCP,endoscopic retrograde cholangiopancreatitis 1

Data of first ESWL session transient adverse events (TAEs)for 67patients subjected to P-ESWL before July 2011were not collected;62patients with complications were excluded from this analysis;thus,the total number of patients included in the analysis of first ESWL TAE was 505;among these patients,133suffered from TAE.2

Targeted stones during first ESWL session of one patient could be multiple and distributed in different locations.3

To avoid overlapping effect,these variates were not included in the multivariate analysis.

D o w n l o a d e d b y : I P -P r o x y U n i v e r s i t y o f C h i c a g o , U n i v e r s i t y o f C h i c a g o . C o p y r i g h t e d m a t e r i a l.

of chronic pancreatitis and P-ESWL,which directly affects the duration of chronic pancreatitis course,did not predict the risk of complications.This result can be attributed to the fact that the functional loss of the pancreas is not associated with the time course.

Pancreas divisum was detected as a risk factor for P-ESWL com-plications,specifically post-ESWL pancreatitis.The relatively nar-rower caliber of the accessory pancreatic duct and the minor pa-pilla may expose patients with pancreas divisum to the risk of pancreatic juice outflow obstruction after P-ESWL.

Similar to ERCP complications,the female sex is a risk factor for P-ESWL complications.The underlying cause may be the dysfunc-tion of the sphincter of Oddi,which is reported as a condition pri-marily affecting women and risk factor for post-ERCP pancreatitis [25].Moreover,women may be more susceptible to an inflam-matory response to pancreas damage [26].In moderate-to-se-vere complications,female sex was also a risk factor in the cur-rent study.Frequent acute attacks during the chronic pancreatitis course suggested a high risk of post-ESWL pancreatitis.A high frequency of acute attacks may indicate that the patient is geneti-cally susceptible to acute pancreatitis and has high enzymatic ac-tivity of the pancreas.

According to the treatment strategy,ERCP was only performed after P-ESWL,indicating that the presence of pancreatic duct stricture could only be evaluated after P-ESWL.The pancreatic duct morphology through ERCP after P-ESWL might differ from the structure before P-ESWL.Nevertheless,pancreatic duct stric-ture and previous treatments are important factors,and these had been considered as potential predictors of P-ESWL complica-tions in this study.However,all of these factors,with the excep-tion of P-ESWL with pancreatic stent in situ,showed P values of >0.10in univariate analyses and were therefore excluded as ini-tial candidates for multivariate analysis.Pancreatic duct stric-ture and previous treatments may not be associated with P-ESWL complications.

No procedure-related factors independently increased the risk of complications.Shock wave frequency and the number of shock waves are important factors in the field of urinary ESWLs.Studies have found that a decrease in frequency (60shocks per minute to 90shocks per minute)is likely to increase the success rate of frag-mentation and improve safety [27].A high number of shock waves is likely to increase the risk of complications.For P-ESWL,the shock wave frequency and the number of shock waves did not affect the rates of complications and TAEs.In the current study,risk factor analyses were limited to the data of the first P-ESWL procedures,and the number of shock waves in a single P-ESWL session was limited to a maximum of 5000shocks.Both of

these factors may have contributed to the results,in which no procedure-related factors were found.

Asymptomatic hyperamylasemia and hematuria were common TAEs with respective incidence rates of 15.5%and 4.2%.Hypera-mylasemia after P-ESWL was not distinguished from pancreatitis in published studies [5,28].Hematuria is the most common man-ifestation after urinary ESWL,and is caused by the shock wave energy delivered to the kidney,resulting in mild renal injury.For P-ESWL,this condition is seldom reported [12]because of lack of observation.The prevalence of acute gastrointestinal mu-cosal injury was 2.7%of P-ESWL procedures in the current study.A study of urinary ESWL has shown gastroduodenal erosions in 80%of patients who underwent pre-and post-ESWL endosco-pies [29].In the current study,overall incidence of asymptomatic hyperamylasemia,hematuria,and acute gastrointestinal injury was 21.2%(27.6%for first ESWL session).

In the second ESWL session in the current study,complications were observed in only 5.4%(22/409)of the patients,which is lower than the rate from the first session.The relatively lower number of complications in the second session may have resulted from the decrease in the stone volume in the pancreas and the partial obstruction release in the pancreatic duct.The pancreas can also adapt to shock waves in subsequent ESWL sessions and this may have contributed to the lower risk.Patient-related fac -tors,which are important in P-ESWL complications,were consis-tent between the first and second P-ESWL sessions.Thus,pa-tients who experienced complications during the first P-ESWL session were prone to complications during subsequent sessions.This study has several limitations.To our knowledge,this study is the first to determine the risk factors for P-ESWL complications;however,there may be unknown factors affecting P-ESWL com-plication rates.Second,the classification of P-ESWL complica-tions established in the study has not been approved by global counterparts;as such,the proposed classification should be in-vestigated further.Third,the absolute number of moderate-to-severe complications was small (11/634,1.7%),and the analysis of risk factors of moderate-to-severe events may therefore pres-ent biased results,despite the large population considered in the study.

In conclusion,the common complications of P-ESWL included post-ESWL pancreatitis,bleeding,infection,steintrasse,and per-foration.Patient-related factors,including female sex,absence of diabetes,absence of steatorrhea,pancreas divisum,and longer interval since diagnosis of chronic pancreatitis,were risk factors for P-ESWL complications.The safety of a previous P-ESWL ses-sion may be a good predictor of the risk in subsequent P-ESWL sessions.The results from this study could help to improve the safety of

P-ESWL.

Table 10Univariate analysis of first pancreatic extracorporeal shock wave lithotripsy (P-ESWL)adverse events for second P-ESWL complications (n =4091).

P-ESWL,pancreatic extracorporeal shock wave lithotripsy;TAE,transient adverse event.1

Among 634patients subjected to P-ESWL(s)treatment,409required further P-ESWL(s)after the first-ESWL sessions.2

Patients free from any complications in the second P-ESWL acted as the control group in analyses for both second P-ESWL complication and second P-ESWL post-ESWL pancreatitis.

D o w n l o a d e d b y : I P -P r o x y U n i v e r s i t y o f C h i c a g o , U n i v e r s i t y o f C h i c a g o . C o p y r i g h t e d m a t e r i a l.

Competing interests :None.

Acknowledgment

!

This study was supported by the National Natural Science Foun-dation of China (Grant Nos.81270541[Z.L.]and 81100316[L.H.H.]),Shanghai Chenguang Program (Grant No.12CG40[H.L.H.]),and Shanghai Rising-Star Program (Grant No.13QA1404600[Z.L.]).

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D o w n l o a d e d b y : I P -P r o x y U n i v e r s i t y o f C h i c a g o , U n i v e r s i t y o f C h i c a g o . C o p y r i g h t e d m a t e r i a l.

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