Introduction
Endoscopic ultrasound-guided drainage (EUS-GD) is replacing surgical treatment of pancreatic pseudocysts (PPC)1 regardless that now there is agreement that endoscopic treatment must be the first line therapy for PPC2-5, there are some unanswered questions. There is no consensus about if patients with EUS-GD of PPC could be discharged the same day or if the patient must stay at least one night in hospital. Many endosonographers leave patients in hospital, regardless, they are asymptomatic after procedure and others prefer to discharge the patient the same day of the procedure. In an email survey made by one of the authors (free-trade agreements [FTA]) with six top endosonographers around the world (France, the United States, Canada, and Brazil), four of six endosonographers prefer to discharge the patient to home the day after the procedure, regardless, they are asymptomatic. Two of the endosonographers consulted also recommend that antibiotics should be given up to 7 days after drainage. This is an important topic because space in the third level hospitals and costs. The aim was to report adverse events rate in the first 24 h after procedure of patients with PPC treated by EUS-GD with focus in the question about if to stay for one night in hospital could represent some benefit to patients.
Materials and methods
A retrospective analysis of data obtained prospectively was conducted. Patients were seen from 2008 to 2014 at the National Institute of Medical Sciences and Nutrition Salvador Zubirán at Mexico City, Mexico. PPC was defined as a fluid collection in the pancreatic/peripancreatic area that had a well-defined wall and contained no solid debris or recognizable parenchymal necrosis6. All patients gave their written informed consent before the procedure and all were evaluated routinely with a contrast-enhanced computed tomography (CT) scan before the procedure. Patients were intubated and received prophylactic antibiotics before the procedure (1 g I.V. of ceftazidime 30 min before). A convex linear array echoendoscope was used and once the PPC was identified, it was accessed using a 19-gauge needle (Echo-Tip, Wilson-Cook Medical, Inc., Winston Salem, North Carolina, USA) and a 0.035-inch guidewire was inserted through the needle into the pseudocyst with fluoroscopic guidance. After removal of the needle, we used a needle knife inserted over the guidewire to create a bigger fistula. Finally, the gastric wall was dilated up to 12-15 mm and two double pigtail plastic stents (7F and 4 cm) were deployed for drainage. The procedure was performed in both inpatients and outpatients. In those outpatients, they were observed at least every 4 h and discharged once they were awake and asymptomatic. Decision about if one particular patient was discharged the same day of procedure or if the patient stayed one night in hospital was based on criteria of the treating physician.
We consider complications as follows: perforation was diagnosed when pneumoperitoneum was evident on imaging studies associated with peritoneal signs. Bleeding was defined as any hemorrhagic event that required endotherapy, blood product transfusion, or inpatient observation. Infection was considered if any septic event occurred after the initial endoscopic drainage and was caused by contamination of PPC, proven by new-onset fever, positive blood cultures, or by positive fluid cultures obtained at endoscopic revision5,7. Stent migration was defined as the need to retrieve a stent from within the pseudocyst or the enteral lumen8. 8 weeks after the drainage, an endoscopic retrograde pancreatography or magnetic resonance cholangiopancreatography was performed. Partial ductal disruption was defined as extravasation of contrast from the main pancreatic duct (MPD) with opacification of PD proximal to the disruption9,10. An abrupt cutoff of MPD with or without contrast extravasation, or an inability to traverse this disconnection with a guidewire, was diagnostic of disconnected pancreatic duct syndrome11.
Clinical success was defined as complete resolution or a decrease in size of the PPC to 2 cm or smaller on CT associated with the resolution of symptoms at the 8-week outpatient follow-up evaluation2. Recurrence was defined as PPC found on CT associated with symptoms after an initial resolution2. Reintervention was defined as the need for repeat surgery or endoscopy due to persistent symptoms in association with a residual pseudocyst that was not <50% of the original size on follow-up imaging2.
Statistical analysis
Continuous variables were expressed as means and SD. Categorical data were expressed as absolute numbers and percentages. Differences between groups were analyzed for categorical variables with the Chi-square test, except where the frequency was <5, in which Fisher's exact test was used. For continuous variables, analysis with Mann-Whitney U-test was done. We considered p < 0.05 as statistically significant. Statistical analysis was performed with SPSS version 20.0 for Mac (SPSS Inc., Chicago, EEUU).
Results
A total of 31 procedures in 29 patients with PPC were analyzed. There were 16 (55.2%) men and 13 (44.8%) women with a mean ± SD age of 42.5 ± 14.5 years. Gallstones were the most common etiology of pancreatitis with 15/29 (51.7%) cases. The average diameter of PPC was 9.6 cm (range 4.5-33 cm). Table 1 summarizes the baseline clinical characteristics of patients.
Characteristic | n = 29 (%) |
---|---|
Male | 16 (55.2) |
Age, years | 42.5 ± 14.5 |
BMI | 24.2 ± 4.1 |
Comorbidities | 16 (55.2) |
Cause of pancreatitis | |
Gallstones | 15 (51.7) |
Alcohol | 6 (20.7) |
Hypertriglyceridemia | 2 (6.9) |
Idiopathic | 1 (3.4) |
Unspecified | 5 (17.2) |
BMI: body mass index calculated by dividing the patient's body weight by the square of their height expressed as kg/m2, PPC: pancreatic pseudocyst.
The endoscopic drainage with EUS guidance was performed through transgastric in 23/29 (79.3%) patients and transduodenal in 6/29 (17.2%) patients. The mean number of stents used was 2 (1-4). 12 (41.3%) patients required a nasocystic catheter because of infected PPC. In one patient, a metallic stent was used. The location of PPC in the 29 patients was the pancreatic body in 9 (31%), body-tail in 8 (27.6%), head in 5 (17.2%), tail in 2 (6.9%), uncinate region in 2 (6.9%), and head-body in 2 (6.9%). In one patient, PPC location was not specified. Technical success was 100%, clinical success was 27/29 (93.1%), and three (10.3%) patients had recurrence. In total, 5/31 (16.1%) procedures have adverse events (Table 2).
Patient | Sex/age | Complication | Size of PPC, cm | Time from procedure | Need for hospitalization | Need for surgery | Days of follow-up | Outcome | Reintervention |
---|---|---|---|---|---|---|---|---|---|
1 | F/46 | Bleed | 13 | During procedure | Yes | Yes | 760 | Alive | No |
2 | F/74 | Migration of stent | 8 | 2 years | No | No | 730 | Alive | Yes* |
3 | M/44 | Infection | 15 | Yes | No | 1825 | Alive | Yes** | |
4 | F/33 | Bleed | 16 | During procedure | Yes‡ | No | 720 | Alive | No |
5 | M/36 | Infection | 15 | 5 days | Yes | No | 670 | Alive | Yes** |
*Need for enteroscopy for to get the prosthesis.
**Need for new EUS procedure.
‡Patient was discharged the next day without another adverse event.
Stent migration
One patient had stent migration after 24-month follow-up; in this case, PPC resolved, and in CT, one stent was detected in the small bowel at ileum. Due to intermittent abdominal pain, a double-balloon enteroscopy was performed; this found the stent 30 cm from the ileocecal valve and enabled retrieval of them with a polypectomy loop, with improvement on follow-up.
Infection
The first patient was a male of 36 years old with PPC of 15 cm in the head of the pancreas who back to the emergency department because chills and fever at day 4 after procedure. The second patient was a male of 44 years old with PPC of 15 cm who presented with abdominal pain and fever after 5 days of the drainage. The two patients with infectious adverse events were treated with a second EUS-GD using a nasocystic catheter with irrigation of 1000 mL/day of saline solution for 5 days with clinical and radiological resolution. The infection presented after the first procedure, regardless, both patients received prophylactic antibiotics.
Discussion
According to our data staying one night in hospital, if were not any adverse events during the procedure, does not make a difference. If there is an adverse event, it happens immediately (bleeding and perforation) or days later (infection).
According to our results, in a previous retrospective analysis, only 32% of patients with EUS-GD required hospitalization12. Another study with 30 patients did not found any immediate adverse event procedure related, but four secondary infections were reported13. Siddiqui et al. reported a complication rate of 10.3% (n = 9), they had 5 intraprocedural bleeding, three post-procedure pain, and one patient fever of uncertain etiology14. One RCT (2) with 20 patients with EUS-GD of PPC reported none adverse events in concordance to another study that compares EUS versus EGD7. In Table 3, complications reported in previous studies of EUS-GD of PPC are shown, as it can be seen in that table, of 15 studies reported, 2-23% of the total of complications are during the procedure or < 24 h later and the rest appears after more than 3 days.
Author/year | N | Complications n, (%) | Type complication | Time after procedure | Treatment |
---|---|---|---|---|---|
Krüger 2006 | 35 | 11 (31) | Cyst infection (4) Stent occlusion (4) Limited stent drainage (3) |
- | Endoscopy |
Varadarajulu 2008 | 20 | 0 | - | - | - |
Itoi 200815 | 13 | 0 | - | - | - |
Yasuda 2009 | 26 | 0 | - | - | - |
Varadarajulu 2011 | 20 | 0 | - | - | - |
Sadik 201116 | 16 | 1 (6) | Perforation | 2 days | Surgery |
Varadarajulu 2011 | 148 | 8 (5.4) | Perforation (2) Bleeding (1) Stent migration (1) Infection (4) |
<24 h (3) not specified (4) 1 week (1) |
Surgery (5) Endoscopy (3) |
Puri 201217 | 40 | 3 (7.5) | Bleeding (1) Infection (1) Perforation (1) |
Inmediatly (2) 40 h (1) |
Surgery (1) Conservative (2) |
Seewald 2012*18 | 80 | 21 (26) | Bleeding (12) Perforation (7) Portal air-embolis (1) Ogilvie Syndrome (1) |
Inmediatly (19) Not specified (2) |
Surgery (4) Conservative (5) Self-limited (11) Endoscopy (1) |
Wen 2014 | 118 | 23 (19.5) | Bleeding Infection Migration | - | - |
Siddiqui 2013 | 87 | 11 (12) | Bleeding (5) Pain (3) Fever (1) Stent migration (2) |
Inmediatly (5) (bleeding) 48-72 h (4) 1 month (2) |
Embolization by radiology (1) Self-limited (8) Endoscopically (2) |
Kwon 201319 | 12 | 5 (41) | Fever (3) Stent migration (2) |
2 months (1 stent) 8 months (1 stent) 4-6 weeks (2 fever) |
Pancreatic stent (2) Stent replacemente (1) Nothing (2 stent migration) |
Shah 2015 | 33 | 5 (15) | Pain (3) Stent migration (1) Infection (1) |
- | - |
Kokosis 2015 | 65 | 11 (17) | Infection (4) Perforation (5) Stent migration (1) Bleeding (1) |
24 h (1) Inmediatly (5) Not specifed (5) |
Surgery (3) Self-limited (1) Conservative (6) Radiology (1) |
Kokosis 2015 | 65 | 11 (17) | Infection (4) Perforation (5) Stent migration (1) Bleeding (1) |
24 h (1) Inmediatly (5) Not specifed (5) |
Surgery (3) Self-limited (1) Conservative (6) Radiology (1) |
Krüger 2006 | 35 | 11 (31) | Cyst infection (4) Stent occlusion (4) Limited stent drainage (3) |
- | Endoscopy |
Varadarajulu 2008 | 20 | 0 | - | - | - |
Itoi 200815 | 13 | 0 | - | - | - |
Yasuda 2009 | 26 | 0 | - | - | - |
Varadarajulu 2011 | 20 | 0 | - | - | - |
Sadik 201116 | 16 | 1 (6) | Perforation | 2 days | Surgery |
Varadarajulu 2011 | 148 | 8 (5.4) | Perforation (2) Bleeding (1) Stent migration (1) Infection (4) |
<24 h (3) not specified (4) 1 week (1) |
Surgery (5) Endoscopy (3) |
Puri 201217 | 40 | 3 (7.5) | Bleeding (1) Infection (1) Perforation (1) |
Inmediatly (2) 40 h (1) |
Surgery (1) Conservative (2) |
Seewald 2012*18 | 80 | 21 (26) | Bleeding (12) Perforation (7) Portal air-embolis (1) Ogilvie Syndrome (1) |
Inmediatly (19) Not specified (2) |
Surgery (4) Conservative (5) Self-limited (11) Endoscopy (1) |
Wen 2014 | 118 | 23 (19.5) | Bleeding Infection Migration | - | - |
Siddiqui 2013 | 87 | 11 (12) | Bleeding (5) Pain (3) Fever (1) Stent migration (2) |
Inmediatly (5) (bleeding) 48-72 h (4) 1 month (2) |
Embolization by radiology (1) Self-limited (8) Endoscopically (2) |
Kwon 201319 | 12 | 5 (41) | Fever (3) Stent migration (2) |
2 months (1 stent) 8 months (1 stent) 4-6 weeks (2 fever) |
Pancreatic stent (2) Stent replacemente (1) Nothing (2 stent migration) |
Shah 2015 | 33 | 5 (15) | Pain (3) Stent migration (1) Infection (1) |
- | - |
Kokosis 2015 | 65 | 11 (17) | Infection (4) Perforation (5) Stent migration (1) Bleeding (1) |
24 h (1) Inmediatly (5) Not specifed (5) |
Surgery (3) Self-limited (1) Conservative (6) Radiology (1) |
Kokosis 2015 | 65 | 11 (17) | Infection (4) Perforation (5) Stent migration (1) Bleeding (1) |
24 h (1) Inmediatly (5) Not specifed (5) |
Surgery (3) Self-limited (1) Conservative (6) Radiology (1) |
WEN ◊ in chinese, only abstract is available in English
*WON and PQP
The complication rate in our study was 16.1% and is according with previous reports2,7,15-21. For us, bleeding was the more important complication and we think that the use of needle knife to create a bigger fistula could explain this. Other authors recommend the use of a cystostome 6F after initial puncture; however, unfortunately, this is not widely available in our country. We have two patients with infection of PPC after the initial drainage. The occurrence of post-puncture infections has been attempted to prevent with the use of prophylactic antibiotics; however, these are not 100% effective. It is currently recommended that patients with pseudocysts with viscous debris-laden fluid the use of a nasocystic drain for the purpose of performing either “in bolus” or continuous lavage14. At this moment, there is no information on how long after drainage, the nasocystic drain must be in place or if there is any difference between doing them continuously or “in bolus.” According to our experience, when PPCs are large (> 15 cm) and the contents are clearly purulent, it is more appropriate to perform the washing through the nasoabscess catheter “in bolus” and not continuously, because at least in our experience, it causes a higher frequency of patients with systemic inflammatory response.
There are some limitations of our study; first, the retrospective design. However, for our knowledge, there is a lack of studies specifically focus on complications of EUS-guided PPC drainage21. Our data could be important for future study designs and reviews.
Conclusion
There is not a clear reason because patients with PPC and EUS-GD need for staying one night in hospital if was not any adverse event during the procedure.
Disclosure: All authors disclosed no financial relationship relevant to this publication.
Authors' Contributions
Félix I. Téllez-Ávila design the study; Félix I. Téllez-Ávila and Miguel A. Ramírez-Luna were attending doctors and performed endoscopies; Félix I. Téllez-Ávila, Luis Eduardo Casasola-Sánchez, Angela Saul, Carlos Chan, Jorge Hernández-Calleros and Luis Uscanga-Domínguez organized the report; and Félix I. Téllez-Ávila, Luis Eduardo Casasola-Sánchez, Angela Saul, Carlos Chan, Jorge Hernández-Calleros and Luis Uscanga-Domínguez wrote the paper.