- Email: [email protected]
Preliminary report on a new, fully covered, metal stent designed for the treatment of pancreatic fluid collections
Preliminary report on a new, fully covered, metal stent designed for the treatment of pancreatic fluid collections Natsuyo Yamamoto, MD, PhD,1 Hiroyuki Isayama, MD, PhD,1 Hiroshi Kawakami, MD, PhD,2 Naoki Sasahira, MD, PhD,3 Tsuyoshi Hamada, MD,1 Yukiko Ito, MD, PhD,4 Naminatsu Takahara, MD,1 Rie Uchino, MD,1 Koji Miyabayashi, MD, PhD,1 Suguru Mizuno, MD, PhD,1 Hirofumi Kogure, MD, PhD,5 Takashi Sasaki, MD, PhD,1 Yousuke Nakai, MD, PhD,1 Masaki Kuwatani, MD, PhD,2 Kenji Hirano, MD, PhD,1 Minoru Tada, MD, PhD,1 Kazuhiko Koike, MD, PhD1 Tokyo, Japan
Background: Endoscopic transluminal treatment of pancreatic fluid collections (PFC) has been reported as an effective alternative approach to surgical treatment. A wide, short stent with an anti-migration system has been developed. Objective: To evaluate a newly developed, fully covered, self-expandable metal stent (FCSEMS) customized for cystogastrostomy. Design: Retrospective case series. Setting: Tertiary-care academic medical centers and affiliated hospitals. Patients: Nine patients who underwent endoscopic treatment of PFCs (5 with pseudocysts and 4 with walled-off pancreatic necrosis). Intervention: Stent deployment after endoscopic US-guided puncture. Irrigation and necrosectomy were performed at the discretion of the endoscopist. Main Outcome Measurements: Technical and clinical success rate, complications, and removability. Results: The FCSEMS was inserted successfully in all cases (9/9, 100%). Clinical success was achieved in 7 of 9 cases (77.8%). No early complications associated with the procedure were observed. Late complications were observed in 2 cases (bleeding and asymptomatic migration). The FCSEMS was removed without any complications in all 6 cases where it was attempted after the procedure had been completed (100%). Limitations: This was a retrospective evaluation of a small number of cases. The FCSEMS was always inserted via the transgastric route. Follow-up duration was short. Conclusion: The endoscopic approach that uses this new FCSEMS is feasible for the treatment of PFCs. However, further evaluation is required.
Endoscopic transluminal treatment of pancreatic fluid collections (PFCs) is an effective alternative to surgical treatment.1,2 After endosonography-guided puncture, drainage, irrigation, or direct endoscopic necrosectomy (DEN) may be performed, depending on the PFC status.3 The success rate, mortality, and length of hospital stay associated with this minimally invasive
treatment are superior to those for conventional surgical treatment,4,5 thereby resulting in improved mortality of severe pancreatitis.4,6 Pancreatic pseudocyst usually is treated by using drainage and/or irrigation. A plastic stent used for drainage is susceptible to obstruction and migration, leading to a recurrence of symptoms. In the treatment of walled-off
Abbreviations: DEN, direct endoscopic necrosectomy; FCSEMS, fully covered, self-expandable, metal stent; PFC, pancreatic fluid collection; WOPN, walled-off pancreatic necrosis. DISCLOSURE: All authors disclosed no financial relationships relevant to this publication.
ogy, Graduate School of Medicine, Hokkaido University, Sapporo (2); Department of Gastroenterology, Sempo Takanawa Hospital, Tokyo (3), Department of Gastroenterology, Japanese Red Cross Hospital, Tokyo (4), Department of Endoscopy and Endoscopic Surgery, Tokyo University Hospital, Tokyo, Japan (5).
Copyright © 2013 by the American Society for Gastrointestinal Endoscopy 0016-5107/$36.00 http://dx.doi.org/10.1016/j.gie.2013.01.009
Reprint requests: Hiroyuki Isayama, MD, PhD, Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.
Received September 5, 2012. Accepted January 1, 2013.
If you would like to chat with an author of this article, you may contact Dr Isayama at [email protected].
Current affiliations: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo (1); Department of Gastroenterol-
www.giejournal.org
Volume 77, No. 5 : 2013 GASTROINTESTINAL ENDOSCOPY 809
Covered metal stent for pancreatic fluid collection
Yamamoto et al
Take-home Message ●
●
Figure 1. The new fully covered metal stent (Nagi stent, TaewoongMedical Co, Ltd, Gyeonggi-do, Korea)
pancreatic necrosis (WOPN), DEN is often used for the removal of the solid necrotic component.7 However, several sessions of DEN may be required. Multiple plastic stents are used to drain pancreatic fluid and to maintain an adequate tract size. Peritonitis caused by leakage between the enteric and cystic walls may occur. To overcome these problems, a fully covered, selfexpandable, metal stent (FCSEMS) has been used instead of multiple plastic stents.8-10 However, most reports involve a biliary or esophageal stent. Few reports concerning a specialized FCSEMS for gastrocystostomy are available.11,12
METHODS Between December 2011 and July 2012, 9 patients underwent endoscopic treatment for PFC with the use of the new FCSEMS. All the procedures were carried out on an inpatient basis. The stent was inserted by two skilled endoscopists (H.I. and H.K.) in two hospitals. After the treatment, the patients were followed-up in 4 hospitals under consultation with the operator. All patients provided written, informed consent, and the study was approved by our institute’s review board. The indications for this procedure were a (1) symptomatic lesion; (2) walled-off lesion; (3) lesion adherent to the enteric wall, confirmed by both CT scan and EUS images; (4) lesion located in the pancreatic body or tail; and (5) lesion that was difficult or impossible to approach via the duodenal papilla. The exclusion criteria were impaired coagulation, pregnancy, and patient refusal. We used a silicone-covered nitinol stent, 16 mm in diameter and 30 mm long, that was specially designed 810 GASTROINTESTINAL ENDOSCOPY Volume 77, No. 5 : 2013
A new, fully covered, self-expandable, metal stent (FCSEMS) for pancreatic fluid collections (PFCs) is short enough to perform direct endoscopic necrosectomy, and it has a wide flare to prevent migration. An endoscopic approach that uses this new FCSEMS is feasible in the treatment of PFCs of both pancreatic pseudocysts and walled-off pancreatic necrosis.
for temporary gastrocystostomy (Nagi stent, TaewoongMedical Co, Ltd, Gyeonggi-do, Korea) (Fig. 1). This FCSEMS was short enough to reduce the degree of protrusion. The diameter was flared at both ends to 26 mm to provide stability and minimize the risk of migration. The enteric end bore a retrieval suture. The diameter of the delivery system was 10F, so the stent could be inserted via an endoscope. All procedures were performed with patients under conscious sedation with diazepam and pethidine hydrochloride. US endoscopes (GF-UCT240 or GF-UCT260; Olympus, Tokyo, Japan) were used. EUS-guided transgastric puncture was performed by using a 19-gauge needle (Echotip-19, Cook Endoscopy, Winston-Salem, NC). The puncture site was dilated to 4 mm or 6 mm (PET balloon dilator; ConMed Co, Utica, NY), the FCSEMS delivery system was inserted, and the stent was deployed (Fig. 2). Placement of a transnasal drainage tube for irrigation and DEN through the FCSEMS were left to the endoscopists’ discretion (Fig. 3). An endoscope with a water jet channel was used for DEN (GIF260J, 9.9 mm diameter; Olympus). If DEN was planned for the management of WOPN, the tract was dilated to 15 mm (CRE balloon; Boston Scientific, Natick, Mass). Therapeutic endoscopy (GIF-260J; Olympus) was used for DEN. If DEN was planned for the management of WOPN, the tract was dilated to 15 mm (CRE balloon; Boston Scientific). Antibiotics were administered intravenously before the procedure until the level of C-reactive protein was normalized. Anti-acid drugs such as proton-pump inhibitors were not administered. Oral intake was restarted if the patients did not have both pain and severe complications after the procedure. The amount of fluid collection was evaluated by weekly CT scans after the procedure until the shrinkage, and an additional imaging test was performed at the doctors’ discretion. The stent was removed endoscopically after the complete disappearance of the PFC was confirmed by CT scan. However, the timing for removal was determined by the patient’s condition. A follow-up study by CT scan was performed approximately 8 weeks after removal of the stent whenever possible. The success rate, complications, and removability were evaluated. www.giejournal.org
Yamamoto et al
Covered metal stent for pancreatic fluid collection
Figure 2. A, The abdominal computed tomography scan showing widespread fluid collection around the pancreas. B, The metallic stent was inserted through the endoscope. C, The stent was constricted by the gastric wall. D, The constriction disappeared on the next day. E, The fluid was drained through the metallic stent.
Technical success was defined as the correct placement of the FCSEMS. Clinical success was defined as complete shrinking of the PFC or infection resolution without surgical treatment. Early (ⱕ7 days) and late (ⱖ8 days) complications were noted. www.giejournal.org
RESULTS Table 1 shows the treatment data. Nine patients (5 with pancreatic pseudocyst and 4 with WOPN) underwent endoscopic treatment of PFCs with the newly developed Volume 77, No. 5 : 2013 GASTROINTESTINAL ENDOSCOPY 811
Covered metal stent for pancreatic fluid collection
Yamamoto et al
Figure 3. A, Direct necrosectomy performed through the stent. B, Endoscopic view showing necrosis in the stent. C, Three plastic stents and a transnasal drainage tube were placed.
FCSEMS from 7 to 40 days after the onset of pancreatitis. Six of the 9 cases involved suspected disconnected duct syndrome. The FCSEMSs were inserted successfully in all 9 cases (100%). No placement-related complications were ob812 GASTROINTESTINAL ENDOSCOPY Volume 77, No. 5 : 2013
served. The tract was dilated up to 4 mm or 6 mm in the cases with attempted drainage alone. The FCSEMSs were fully expanded in 8 cases (88.9%). A transnasal irrigation tube was placed through the FCEMS in 1 of the 5 cases with pancreatic pseudocyst and in 2 of the 4 cases with www.giejournal.org
Yamamoto et al
Covered metal stent for pancreatic fluid collection
TABLE 1. Treatment data
Full expansion Tract after dilation diameter insertion
Drainage/ Therapy irrigation to oral tube Complications intake insertion DEN (d) Early Late in stent (session)
Patient, age (y), sex
Duration Onset Maximum of to Disconnect lesion placement therapy duct WOPN/ diameter (d) (d) Indication syndrome (cm) PC
1, 68, F
WOPN
32.0
Yes
23
Infection
40
7 days after puncture
15 mm
Yes
Yes
Yes (9)
9
No
No
Yes
2, 39, M
WOPN
8.0
Yes
9
Infection
—
Concurrent
4 mm
Yes
No
No
—
No
No
No (surgical necrosectomy)
3, 53, F
PC
5.9
No
7
Infection
10
Concurrent
4 mm
Yes
No
No
3
No
No
Yes
Timing of stent insertion
Clinical success
4, 39, M
PC
10.5
Yes
17
Pain
60
Concurrent
4 mm
Yes
Yes
No
4
No
No
Yes
5, 47, M
WOPN
30.0
Yes
20
Infection
—
Concurrent
15 mm
Yes
Yes
Yes (3)
—
No
bleeding
Death
6, 53, M
PC
6.0
Yes
24
Infection
12
Concurrent
6 mm
No
No
No
4
No
No
Yes
7, 53, M
WOPN
10.0
Yes
40
Pain
25
Concurrent
6 mm
Yes
No
Yes (4)
4
No
No
Yes
8, 39, F
PC
18.7
No
90
Anorexia
26*
14 days after puncture
4 mm
Yes
No
No
1
No migration
Yes
9, 40, M
PC
10.5
No
21
Pain
†
Concurrent
4 mm
Yes
No
No
3
No
Yes
No
WOPN, Walled-off pancreatic necrosis; PC, pancreatic pseudocyst; DEN, Direct endoscopic necrosectomy. *Asymptomatic migration. †Under treatment.
WOPN. The insertion of a therapeutic endoscope (9.9 mm in diameter) and DEN were achieved in all 3 cases where they were attempted. DEN was performed in 9 sessions in case 1, 3 sessions in case 4, and 4 sessions in case 7. In case 2 (WOPN), insertion of the nasal tube and performance of the endoscopic procedure were impossible because the patient developed violent behavior due to delirium. Additional balloon dilation of the tract before each DEN was not required. No food was found in the case with necrosectomy. We did not observe the inside of the cyst in the case without necrosectomy. Clinical success was achieved in 7 cases (77.8%). Of the 5 pancreatic pseudocyst cases, the pancreatic pseudocyst was successfully drained without DEN in all cases (100%). Complete remission of infection was achieved in 2 of the 4 cases (50.0%) with WOPN. In the other 2 cases, DEN could not be completed because of intracystic bleeding. Another patient required surgical treatment for splenic infarction and abscess 14 days after stent insertion. No early complications were observed. Late complications were observed in 2 patients, including bleeding in 1. Patient 5 died from multiple organ failure. Intraluminal bleeding disrupted drainage and DEN, necessitating transarterial embolization. The bleeding was caused by vessel damage because of inflammation, which was detected on autopsy. Spontaneous migration was observed in 1 patient (case 8), when the stent migrated outward and was passed out of the body without causing symptoms. The endoscopist noticed the migration just before attempting to remove the stent 26 days after insertion. www.giejournal.org
Removal of the FCSEMS was achieved with no complications in all 6 cases in which it was attempted (100%), from 10 to 60 days after insertion.
DISCUSSION We evaluated a new FCSEMS for the treatment of PFC. The placement of multiple plastic stents to maintain a wide tract for drainage, irrigation, and DEN has gained mainstream acceptance but is associated with a high complication rate associated with migration, peritonitis, or bleeding. Multiple stenting requires additional time. When DEN is performed over several sessions, insertion and removal of multiple stents are necessary before and after each DEN, prolonging the procedures. In this regard, the FCSEMS may offer a better alternative. When a biliary or esophageal stent is used for PFC, the longer protrusion on both the stomach and cystic sides entails a risk of contact ulceration, bleeding, or migration. During DEN, such stents interfere with the operation of the endoscope. On the other hand, a shorter stent is associated with a higher risk of migration. The new FCSEMS is short but has a wide flare to prevent migration. This appears to be effective, because we observed asymptomatic migration in only 1 case. In this case, the stent migrated outward. We assumed that the stent migrated out because of shrinkage of the cyst. Recently, an FCSEMS with a novel shape and delivery system specially designed for enterocystostomy was described.11,12 The authors reported that enterocystostomy using this lumen-apposing stent was accomplished with Volume 77, No. 5 : 2013 GASTROINTESTINAL ENDOSCOPY 813
Covered metal stent for pancreatic fluid collection
high technical and clinical success in this pilot observational study. Compared with a lumen-apposing stent, the new FCSEMS has some marked advantages, the main ones being its wide lumen diameter and the thin and simple delivery system. The diameter of this stent is 16 mm, and the delivery system is 10F. In all cases, the stent was inserted without changing to an endoscope with a larger channel diameter. When DEN was performed, the diameter of the stent was large enough to insert a normal or a therapeutic endoscope. The new FCSEMS was inserted and expanded successfully in all cases. Stent replacement was not necessary in any patient. Although the stent was large in diameter, minimal pre-dilation of the tract was needed, which appeared to reduce the risk of leakage. In the pancreatic pseudocyst cases, stent insertion was effective for drainage. In the WOPN cases, DEN was performed successfully through the endoscope. Because DEN cannot be performed through a plastic stent, the FCSEMS is superior in this regard. Multiple sessions of DEN were required to achieve complete removal of necrosis, but the initial stent placement avoided the need for tract dilation before each endoscopic procedure. The FCSEMS appears to be useful for both drainage and DEN. However, in the WOPN cases without appropriate debridement, the result was unfavorable. The clinical success rate indicates that, even when a large-diameter tract was maintained, solid necrosis could not be completely drained spontaneously. There was one serious complication where bleeding occurred. Angiography revealed that the point of bleeding was distinct from the stent, and we believe that the vessel damage was not related to the stent but was the result of inflammation or necrosectomy. Because this was a pilot study, the complication rate was not fully analyzed and needs to be evaluated more thoroughly in a larger study. One limitation of this study is that it was a retrospective evaluation of a small number of cases. Second, the FCSEMS was inserted via the transgastric route in every case. Stent insertion via the transduodenal route could be associated with different complications, such as migration or leakage. Third, the follow-up duration was short, so recurrence and other complications might have been un-
814 GASTROINTESTINAL ENDOSCOPY Volume 77, No. 5 : 2013
Yamamoto et al
derestimated. Further studies are needed to evaluate these aspects. In conclusion, an endoscopic approach that uses this new FCSEMS is feasible in the treatment of PFCs, in both pancreatic pseudocysts and WOPN.
REFERENCES 1. Jacobson BC, Baron TH, Adler DG, et al. ASGE guideline: The role of endoscopy in the diagnosis and the management of cystic lesions and inflammatory fluid collections of the pancreas. Gastrointest Endosc 2005;61:363-70. 2. Seewald S, Ang TL, Kida M, et al. EUS 2008 Working Group document: evaluation of EUS-guided drainage of pancreatic-fluid collections (with video). Gastrointest Endosc 2009;69:S13-21. 3. Baron TH, Harewood GC, Morgan DE, et al. Outcome differences after endoscopic drainage of pancreatic necrosis, acute pancreatic pseudocysts, and chronic pancreatic pseudocysts. Gastrointest Endosc 2002; 56:7-17. 4. van Santvoort HC, Besselink MG, Bakker OJ, et al. A step-up approach or open necrosectomy for necrotizing pancreatitis. N Engl J Med 2010;362: 1491-502. 5. Seifert H, Biermer M, Schmitt W, et al. Transluminal endoscopic necrosectomy after acute pancreatitis: a multicentre study with long-term follow-up (the GEPARD Study). Gut 2009;58:1260-6. 6. Bakker OJ, van Santvoort HC, van Brunschot S, et al. Endoscopic transgastric vs surgical necrosectomy for infected necrotizing pancreatitis: a randomized trial. JAMA 2012;307:1053-61. 7. Gardner TB, Coelho-Prabhu N, Gordon SR, et al. Direct endoscopic necrosectomy for the treatment of walled-off pancreatic necrosis: results from a multicenter U.S. series. Gastrointest Endosc 2011;73:718-26. 8. Talreja JP, Shami VM, Ku J, et al. Transenteric drainage of pancreatic-fluid collections with fully covered self-expanding metallic stents (with video). Gastrointest Endosc 2008;68:1199-203. 9. Belle S, Collet P, Post S, et al. Temporary cystogastrostomy with selfexpanding metallic stents for pancreatic necrosis. Endoscopy 2010;42: 493-5. 10. Tarantino I, Traina M, Barresi L, et al. Transgastric plus transduodenal necrosectomy with temporary metal stents placement for treatment of large pancreatic necrosis. Pancreas 2010;39:269-70. 11. Itoi T, Binmoeller KF, Shah J, et al. Clinical evaluation of a novel lumenapposing metal stent for endosonography-guided pancreatic pseudocyst and gallbladder drainage (with videos). Gastrointest Endosc 2012; 75:870-6. 12. Gornals JB, Loras C, Mast R, et al. Endoscopic ultrasound-guided transesophageal drainage of a mediastinal pancreatic pseudocyst using a novel lumen-apposing metal stent. Endoscopy 2012;44(suppl 2): E211-2.
www.giejournal.org
Background: Endoscopic transluminal treatment of pancreatic fluid collections (PFC) has been reported as an effective alternative approach to surgical treatment. A wide, short stent with an anti-migration system has been developed. Objective: To evaluate a newly developed, fully covered, self-expandable metal stent (FCSEMS) customized for cystogastrostomy. Design: Retrospective case series. Setting: Tertiary-care academic medical centers and affiliated hospitals. Patients: Nine patients who underwent endoscopic treatment of PFCs (5 with pseudocysts and 4 with walled-off pancreatic necrosis). Intervention: Stent deployment after endoscopic US-guided puncture. Irrigation and necrosectomy were performed at the discretion of the endoscopist. Main Outcome Measurements: Technical and clinical success rate, complications, and removability. Results: The FCSEMS was inserted successfully in all cases (9/9, 100%). Clinical success was achieved in 7 of 9 cases (77.8%). No early complications associated with the procedure were observed. Late complications were observed in 2 cases (bleeding and asymptomatic migration). The FCSEMS was removed without any complications in all 6 cases where it was attempted after the procedure had been completed (100%). Limitations: This was a retrospective evaluation of a small number of cases. The FCSEMS was always inserted via the transgastric route. Follow-up duration was short. Conclusion: The endoscopic approach that uses this new FCSEMS is feasible for the treatment of PFCs. However, further evaluation is required.
Endoscopic transluminal treatment of pancreatic fluid collections (PFCs) is an effective alternative to surgical treatment.1,2 After endosonography-guided puncture, drainage, irrigation, or direct endoscopic necrosectomy (DEN) may be performed, depending on the PFC status.3 The success rate, mortality, and length of hospital stay associated with this minimally invasive
treatment are superior to those for conventional surgical treatment,4,5 thereby resulting in improved mortality of severe pancreatitis.4,6 Pancreatic pseudocyst usually is treated by using drainage and/or irrigation. A plastic stent used for drainage is susceptible to obstruction and migration, leading to a recurrence of symptoms. In the treatment of walled-off
Abbreviations: DEN, direct endoscopic necrosectomy; FCSEMS, fully covered, self-expandable, metal stent; PFC, pancreatic fluid collection; WOPN, walled-off pancreatic necrosis. DISCLOSURE: All authors disclosed no financial relationships relevant to this publication.
ogy, Graduate School of Medicine, Hokkaido University, Sapporo (2); Department of Gastroenterology, Sempo Takanawa Hospital, Tokyo (3), Department of Gastroenterology, Japanese Red Cross Hospital, Tokyo (4), Department of Endoscopy and Endoscopic Surgery, Tokyo University Hospital, Tokyo, Japan (5).
Copyright © 2013 by the American Society for Gastrointestinal Endoscopy 0016-5107/$36.00 http://dx.doi.org/10.1016/j.gie.2013.01.009
Reprint requests: Hiroyuki Isayama, MD, PhD, Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.
Received September 5, 2012. Accepted January 1, 2013.
If you would like to chat with an author of this article, you may contact Dr Isayama at [email protected].
Current affiliations: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo (1); Department of Gastroenterol-
www.giejournal.org
Volume 77, No. 5 : 2013 GASTROINTESTINAL ENDOSCOPY 809
Covered metal stent for pancreatic fluid collection
Yamamoto et al
Take-home Message ●
●
Figure 1. The new fully covered metal stent (Nagi stent, TaewoongMedical Co, Ltd, Gyeonggi-do, Korea)
pancreatic necrosis (WOPN), DEN is often used for the removal of the solid necrotic component.7 However, several sessions of DEN may be required. Multiple plastic stents are used to drain pancreatic fluid and to maintain an adequate tract size. Peritonitis caused by leakage between the enteric and cystic walls may occur. To overcome these problems, a fully covered, selfexpandable, metal stent (FCSEMS) has been used instead of multiple plastic stents.8-10 However, most reports involve a biliary or esophageal stent. Few reports concerning a specialized FCSEMS for gastrocystostomy are available.11,12
METHODS Between December 2011 and July 2012, 9 patients underwent endoscopic treatment for PFC with the use of the new FCSEMS. All the procedures were carried out on an inpatient basis. The stent was inserted by two skilled endoscopists (H.I. and H.K.) in two hospitals. After the treatment, the patients were followed-up in 4 hospitals under consultation with the operator. All patients provided written, informed consent, and the study was approved by our institute’s review board. The indications for this procedure were a (1) symptomatic lesion; (2) walled-off lesion; (3) lesion adherent to the enteric wall, confirmed by both CT scan and EUS images; (4) lesion located in the pancreatic body or tail; and (5) lesion that was difficult or impossible to approach via the duodenal papilla. The exclusion criteria were impaired coagulation, pregnancy, and patient refusal. We used a silicone-covered nitinol stent, 16 mm in diameter and 30 mm long, that was specially designed 810 GASTROINTESTINAL ENDOSCOPY Volume 77, No. 5 : 2013
A new, fully covered, self-expandable, metal stent (FCSEMS) for pancreatic fluid collections (PFCs) is short enough to perform direct endoscopic necrosectomy, and it has a wide flare to prevent migration. An endoscopic approach that uses this new FCSEMS is feasible in the treatment of PFCs of both pancreatic pseudocysts and walled-off pancreatic necrosis.
for temporary gastrocystostomy (Nagi stent, TaewoongMedical Co, Ltd, Gyeonggi-do, Korea) (Fig. 1). This FCSEMS was short enough to reduce the degree of protrusion. The diameter was flared at both ends to 26 mm to provide stability and minimize the risk of migration. The enteric end bore a retrieval suture. The diameter of the delivery system was 10F, so the stent could be inserted via an endoscope. All procedures were performed with patients under conscious sedation with diazepam and pethidine hydrochloride. US endoscopes (GF-UCT240 or GF-UCT260; Olympus, Tokyo, Japan) were used. EUS-guided transgastric puncture was performed by using a 19-gauge needle (Echotip-19, Cook Endoscopy, Winston-Salem, NC). The puncture site was dilated to 4 mm or 6 mm (PET balloon dilator; ConMed Co, Utica, NY), the FCSEMS delivery system was inserted, and the stent was deployed (Fig. 2). Placement of a transnasal drainage tube for irrigation and DEN through the FCSEMS were left to the endoscopists’ discretion (Fig. 3). An endoscope with a water jet channel was used for DEN (GIF260J, 9.9 mm diameter; Olympus). If DEN was planned for the management of WOPN, the tract was dilated to 15 mm (CRE balloon; Boston Scientific, Natick, Mass). Therapeutic endoscopy (GIF-260J; Olympus) was used for DEN. If DEN was planned for the management of WOPN, the tract was dilated to 15 mm (CRE balloon; Boston Scientific). Antibiotics were administered intravenously before the procedure until the level of C-reactive protein was normalized. Anti-acid drugs such as proton-pump inhibitors were not administered. Oral intake was restarted if the patients did not have both pain and severe complications after the procedure. The amount of fluid collection was evaluated by weekly CT scans after the procedure until the shrinkage, and an additional imaging test was performed at the doctors’ discretion. The stent was removed endoscopically after the complete disappearance of the PFC was confirmed by CT scan. However, the timing for removal was determined by the patient’s condition. A follow-up study by CT scan was performed approximately 8 weeks after removal of the stent whenever possible. The success rate, complications, and removability were evaluated. www.giejournal.org
Yamamoto et al
Covered metal stent for pancreatic fluid collection
Figure 2. A, The abdominal computed tomography scan showing widespread fluid collection around the pancreas. B, The metallic stent was inserted through the endoscope. C, The stent was constricted by the gastric wall. D, The constriction disappeared on the next day. E, The fluid was drained through the metallic stent.
Technical success was defined as the correct placement of the FCSEMS. Clinical success was defined as complete shrinking of the PFC or infection resolution without surgical treatment. Early (ⱕ7 days) and late (ⱖ8 days) complications were noted. www.giejournal.org
RESULTS Table 1 shows the treatment data. Nine patients (5 with pancreatic pseudocyst and 4 with WOPN) underwent endoscopic treatment of PFCs with the newly developed Volume 77, No. 5 : 2013 GASTROINTESTINAL ENDOSCOPY 811
Covered metal stent for pancreatic fluid collection
Yamamoto et al
Figure 3. A, Direct necrosectomy performed through the stent. B, Endoscopic view showing necrosis in the stent. C, Three plastic stents and a transnasal drainage tube were placed.
FCSEMS from 7 to 40 days after the onset of pancreatitis. Six of the 9 cases involved suspected disconnected duct syndrome. The FCSEMSs were inserted successfully in all 9 cases (100%). No placement-related complications were ob812 GASTROINTESTINAL ENDOSCOPY Volume 77, No. 5 : 2013
served. The tract was dilated up to 4 mm or 6 mm in the cases with attempted drainage alone. The FCSEMSs were fully expanded in 8 cases (88.9%). A transnasal irrigation tube was placed through the FCEMS in 1 of the 5 cases with pancreatic pseudocyst and in 2 of the 4 cases with www.giejournal.org
Yamamoto et al
Covered metal stent for pancreatic fluid collection
TABLE 1. Treatment data
Full expansion Tract after dilation diameter insertion
Drainage/ Therapy irrigation to oral tube Complications intake insertion DEN (d) Early Late in stent (session)
Patient, age (y), sex
Duration Onset Maximum of to Disconnect lesion placement therapy duct WOPN/ diameter (d) (d) Indication syndrome (cm) PC
1, 68, F
WOPN
32.0
Yes
23
Infection
40
7 days after puncture
15 mm
Yes
Yes
Yes (9)
9
No
No
Yes
2, 39, M
WOPN
8.0
Yes
9
Infection
—
Concurrent
4 mm
Yes
No
No
—
No
No
No (surgical necrosectomy)
3, 53, F
PC
5.9
No
7
Infection
10
Concurrent
4 mm
Yes
No
No
3
No
No
Yes
Timing of stent insertion
Clinical success
4, 39, M
PC
10.5
Yes
17
Pain
60
Concurrent
4 mm
Yes
Yes
No
4
No
No
Yes
5, 47, M
WOPN
30.0
Yes
20
Infection
—
Concurrent
15 mm
Yes
Yes
Yes (3)
—
No
bleeding
Death
6, 53, M
PC
6.0
Yes
24
Infection
12
Concurrent
6 mm
No
No
No
4
No
No
Yes
7, 53, M
WOPN
10.0
Yes
40
Pain
25
Concurrent
6 mm
Yes
No
Yes (4)
4
No
No
Yes
8, 39, F
PC
18.7
No
90
Anorexia
26*
14 days after puncture
4 mm
Yes
No
No
1
No migration
Yes
9, 40, M
PC
10.5
No
21
Pain
†
Concurrent
4 mm
Yes
No
No
3
No
Yes
No
WOPN, Walled-off pancreatic necrosis; PC, pancreatic pseudocyst; DEN, Direct endoscopic necrosectomy. *Asymptomatic migration. †Under treatment.
WOPN. The insertion of a therapeutic endoscope (9.9 mm in diameter) and DEN were achieved in all 3 cases where they were attempted. DEN was performed in 9 sessions in case 1, 3 sessions in case 4, and 4 sessions in case 7. In case 2 (WOPN), insertion of the nasal tube and performance of the endoscopic procedure were impossible because the patient developed violent behavior due to delirium. Additional balloon dilation of the tract before each DEN was not required. No food was found in the case with necrosectomy. We did not observe the inside of the cyst in the case without necrosectomy. Clinical success was achieved in 7 cases (77.8%). Of the 5 pancreatic pseudocyst cases, the pancreatic pseudocyst was successfully drained without DEN in all cases (100%). Complete remission of infection was achieved in 2 of the 4 cases (50.0%) with WOPN. In the other 2 cases, DEN could not be completed because of intracystic bleeding. Another patient required surgical treatment for splenic infarction and abscess 14 days after stent insertion. No early complications were observed. Late complications were observed in 2 patients, including bleeding in 1. Patient 5 died from multiple organ failure. Intraluminal bleeding disrupted drainage and DEN, necessitating transarterial embolization. The bleeding was caused by vessel damage because of inflammation, which was detected on autopsy. Spontaneous migration was observed in 1 patient (case 8), when the stent migrated outward and was passed out of the body without causing symptoms. The endoscopist noticed the migration just before attempting to remove the stent 26 days after insertion. www.giejournal.org
Removal of the FCSEMS was achieved with no complications in all 6 cases in which it was attempted (100%), from 10 to 60 days after insertion.
DISCUSSION We evaluated a new FCSEMS for the treatment of PFC. The placement of multiple plastic stents to maintain a wide tract for drainage, irrigation, and DEN has gained mainstream acceptance but is associated with a high complication rate associated with migration, peritonitis, or bleeding. Multiple stenting requires additional time. When DEN is performed over several sessions, insertion and removal of multiple stents are necessary before and after each DEN, prolonging the procedures. In this regard, the FCSEMS may offer a better alternative. When a biliary or esophageal stent is used for PFC, the longer protrusion on both the stomach and cystic sides entails a risk of contact ulceration, bleeding, or migration. During DEN, such stents interfere with the operation of the endoscope. On the other hand, a shorter stent is associated with a higher risk of migration. The new FCSEMS is short but has a wide flare to prevent migration. This appears to be effective, because we observed asymptomatic migration in only 1 case. In this case, the stent migrated outward. We assumed that the stent migrated out because of shrinkage of the cyst. Recently, an FCSEMS with a novel shape and delivery system specially designed for enterocystostomy was described.11,12 The authors reported that enterocystostomy using this lumen-apposing stent was accomplished with Volume 77, No. 5 : 2013 GASTROINTESTINAL ENDOSCOPY 813
Covered metal stent for pancreatic fluid collection
high technical and clinical success in this pilot observational study. Compared with a lumen-apposing stent, the new FCSEMS has some marked advantages, the main ones being its wide lumen diameter and the thin and simple delivery system. The diameter of this stent is 16 mm, and the delivery system is 10F. In all cases, the stent was inserted without changing to an endoscope with a larger channel diameter. When DEN was performed, the diameter of the stent was large enough to insert a normal or a therapeutic endoscope. The new FCSEMS was inserted and expanded successfully in all cases. Stent replacement was not necessary in any patient. Although the stent was large in diameter, minimal pre-dilation of the tract was needed, which appeared to reduce the risk of leakage. In the pancreatic pseudocyst cases, stent insertion was effective for drainage. In the WOPN cases, DEN was performed successfully through the endoscope. Because DEN cannot be performed through a plastic stent, the FCSEMS is superior in this regard. Multiple sessions of DEN were required to achieve complete removal of necrosis, but the initial stent placement avoided the need for tract dilation before each endoscopic procedure. The FCSEMS appears to be useful for both drainage and DEN. However, in the WOPN cases without appropriate debridement, the result was unfavorable. The clinical success rate indicates that, even when a large-diameter tract was maintained, solid necrosis could not be completely drained spontaneously. There was one serious complication where bleeding occurred. Angiography revealed that the point of bleeding was distinct from the stent, and we believe that the vessel damage was not related to the stent but was the result of inflammation or necrosectomy. Because this was a pilot study, the complication rate was not fully analyzed and needs to be evaluated more thoroughly in a larger study. One limitation of this study is that it was a retrospective evaluation of a small number of cases. Second, the FCSEMS was inserted via the transgastric route in every case. Stent insertion via the transduodenal route could be associated with different complications, such as migration or leakage. Third, the follow-up duration was short, so recurrence and other complications might have been un-
814 GASTROINTESTINAL ENDOSCOPY Volume 77, No. 5 : 2013
Yamamoto et al
derestimated. Further studies are needed to evaluate these aspects. In conclusion, an endoscopic approach that uses this new FCSEMS is feasible in the treatment of PFCs, in both pancreatic pseudocysts and WOPN.
REFERENCES 1. Jacobson BC, Baron TH, Adler DG, et al. ASGE guideline: The role of endoscopy in the diagnosis and the management of cystic lesions and inflammatory fluid collections of the pancreas. Gastrointest Endosc 2005;61:363-70. 2. Seewald S, Ang TL, Kida M, et al. EUS 2008 Working Group document: evaluation of EUS-guided drainage of pancreatic-fluid collections (with video). Gastrointest Endosc 2009;69:S13-21. 3. Baron TH, Harewood GC, Morgan DE, et al. Outcome differences after endoscopic drainage of pancreatic necrosis, acute pancreatic pseudocysts, and chronic pancreatic pseudocysts. Gastrointest Endosc 2002; 56:7-17. 4. van Santvoort HC, Besselink MG, Bakker OJ, et al. A step-up approach or open necrosectomy for necrotizing pancreatitis. N Engl J Med 2010;362: 1491-502. 5. Seifert H, Biermer M, Schmitt W, et al. Transluminal endoscopic necrosectomy after acute pancreatitis: a multicentre study with long-term follow-up (the GEPARD Study). Gut 2009;58:1260-6. 6. Bakker OJ, van Santvoort HC, van Brunschot S, et al. Endoscopic transgastric vs surgical necrosectomy for infected necrotizing pancreatitis: a randomized trial. JAMA 2012;307:1053-61. 7. Gardner TB, Coelho-Prabhu N, Gordon SR, et al. Direct endoscopic necrosectomy for the treatment of walled-off pancreatic necrosis: results from a multicenter U.S. series. Gastrointest Endosc 2011;73:718-26. 8. Talreja JP, Shami VM, Ku J, et al. Transenteric drainage of pancreatic-fluid collections with fully covered self-expanding metallic stents (with video). Gastrointest Endosc 2008;68:1199-203. 9. Belle S, Collet P, Post S, et al. Temporary cystogastrostomy with selfexpanding metallic stents for pancreatic necrosis. Endoscopy 2010;42: 493-5. 10. Tarantino I, Traina M, Barresi L, et al. Transgastric plus transduodenal necrosectomy with temporary metal stents placement for treatment of large pancreatic necrosis. Pancreas 2010;39:269-70. 11. Itoi T, Binmoeller KF, Shah J, et al. Clinical evaluation of a novel lumenapposing metal stent for endosonography-guided pancreatic pseudocyst and gallbladder drainage (with videos). Gastrointest Endosc 2012; 75:870-6. 12. Gornals JB, Loras C, Mast R, et al. Endoscopic ultrasound-guided transesophageal drainage of a mediastinal pancreatic pseudocyst using a novel lumen-apposing metal stent. Endoscopy 2012;44(suppl 2): E211-2.
www.giejournal.org