Multicenter study of plastic vs. self-expanding metal stents in endoscopic ultrasound-guided drainage of walled-off pancreatic necrosis – PROMETHEUS: a randomized controlled trial protocol

Gornals, Joan B.; Pérez-Miranda, Manuel; Vazquez-Sequeiros, Enrique; Vila, Juan J.; Esteban, José M.; González-Húix, Ferrán; Guarner-Argente, Carlos; Sánchez-Yagüe, Andrés; Terán, Álvaro; Bas‐Cutrina, Francesc; Serna, Carlos De La; Paredes, Ana Garcia De; Ballester, Raquel; Velasquez-Rodriguez, Julio G.; Salord, Sílvia; Tebé, Cristian; Hereu, Pilar; Videla, Sebas

doi:10.1186/s13063-019-3988-x

Cited by 12 publications

(8 citation statements)

References 29 publications

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“…In conclusion, we confirm the results of a recent systematic review of mainly retrospective studies, reporting that there is no increased bleeding risk when using LAMS 22. The results of two ongoing randomised trials will provide more information on LAMS safety 23 24…”

Section: Discussionsupporting

confidence: 87%

Comparison of lumen-apposing metal stents versus double-pigtail plastic stents for infected necrotising pancreatitis

Boxhoorn

Verdonk

Besselink

et al. 2022

Gut

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ObjectiveLumen-apposing metal stents (LAMS) are believed to clinically improve endoscopic transluminal drainage of infected necrosis when compared with double-pigtail plastic stents. However, comparative data from prospective studies are very limited.DesignPatients with infected necrotising pancreatitis, who underwent an endoscopic step-up approach with LAMS within a multicentre prospective cohort study were compared with the data of 51 patients in the randomised TENSION trial who had been assigned to the endoscopic step-up approach with double-pigtail plastic stents. The clinical study protocol was otherwise identical for both groups. Primary end point was the need for endoscopic transluminal necrosectomy. Secondary end points included mortality, major complications, hospital stay and healthcare costs.ResultsA total of 53 patients were treated with LAMS in 16 hospitals during 27 months. The need for endoscopic transluminal necrosectomy was 64% (n=34) and was not different from the previous trial using plastic stents (53%, n=27)), also after correction for baseline characteristics (OR 1.21 (95% CI 0.45 to 3.23)). Secondary end points did not differ between groups either, which also included bleeding requiring intervention—5 patients (9%) after LAMS placement vs 11 patients (22%) after placement of plastic stents (relative risk 0.44; 95% CI 0.16 to 1.17). Total healthcare costs were also comparable (mean difference −€6348, bias-corrected and accelerated 95% CI −€26 386 to €10 121).ConclusionOur comparison of two patient groups from two multicentre prospective studies with a similar design suggests that LAMS do not reduce the need for endoscopic transluminal necrosectomy when compared with double-pigtail plastic stents in patients with infected necrotising pancreatitis. Also, the rate of bleeding complications was comparable.

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Section: Discussionsupporting

confidence: 87%

Comparison of lumen-apposing metal stents versus double-pigtail plastic stents for infected necrotising pancreatitis

Boxhoorn

Verdonk

Besselink

et al. 2022

Gut

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“…Despite the theoretical advantage of LAMS over DPPS for drainage of PFCs, we believe that more randomized controlled studies are needed to corroborate this advantage. Actually, two randomized controlled studies are currently being developed 34,35 . Our study has some limitations; in the same way as the previous meta‐analyses, most of the studies that comprise it are retrospective, with only one being a randomized controlled trial.…”

Section: Discussionmentioning

confidence: 99%

Head‐to‐head comparison between endoscopic ultrasound guided lumen apposing metal stent and plastic stents for the treatment of pancreatic fluid collections: A systematic review and meta‐analysis

Guzmán-Calderón

Chacaltana

Díaz

et al. 2021

J Hepato Biliary Pancreat

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Background/Aims Peripancreatic fluid collections (PFCs) result from acute or chronic pancreatic inflammation that suffers a rupture of its ducts. Currently, there exists three options for drainage or debridement of pancreatic pseudocysts and walled‐off necrosis (WON). The traditional procedure is drainage by placing double pigtail plastic stents (DPPS); lumen‐apposing metal stent (LAMS) has a biflanged design with a wide lumen that avoids occlusion with necrotic tissue, which is more common with DPPS and reduces the possibility of migration. We performed a systematic review and meta‐analyses head‐to‐head, including only studies that compare the two main techniques to drainage of PFCs: LAMS vs DPPS. Methods We conducted a systematic review in different databases, such as PubMed, OVID, Medline, and Cochrane Databases. This meta‐analysis considers studies published from 2014 to 2020, including only studies that compare the two main techniques to drainage of PFCs: LAMS vs DPPS. Results Thirteen studies were included in the meta‐analyses. Only one of all studies was a randomized controlled trial. These studies comprise 1584 patients; 68.2% were male, and 31.8% were female. Six hundred sixty‐three patients (41.9%) were treated with LAMS, and 921 (58.1%) were treated with DPPS. Six studies included only WON in their analysis, two included only pancreatic pseudocysts, and five studies included both pancreatic pseudocysts and WON. The technical success was similar in patients treated with LAMS and DPPS (97.6% vs 97.5%, respectively, P = .986, RR = 1.00 [95% CI 0.93‐1.08]). The clinical success was similar in both groups (LAMS: 90.1% vs DPPS: 84.2%, P = .139, RR = 1.063 [95% CI 0.98‐1.15]). Patients treated with LAMS had a lower complication rate than the DPPS groups, with a significant statistical difference (LAMS: 16.0% vs DPPS: 20.2%, P = .009, RR = 0.746 [95% CI 0.60‐0.93]). Bleeding was the most common complication in the LAMS group (33 patients, [5.0%]), whereas infection was the most common complication in the DPPS group (56 patients, [6.1%]). The LAMS migration rate was lower than in the DPPS (0.9% vs 2.2%, respectively, P = .05). The mortality rate was similar in both groups, 0.6% in the LAMS group (four patients) and 0.4% in the DPPS group (four patients; P = .640). Conclusion The PFCs drainage is an indication when persistent symptoms or PFCs‐related complications exist. EUS guided drainage with LAMS has similar technical and clinical success to DPPS drainage for the management of PFCs. The technical and clinical success rates are high in both groups. However, LAMS drainage has a lower adverse events rate than DPPS drainage. More randomized controlled trials are needed to confirm the real advantage of LAMS drainage over DPPS drainage.

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“…They inserted at least one or more PS if size of WON was less than 10 cm and at least 2 or more if the WON size was more than 10 cm. 24 In a RCT comparing endoscopic versus laparoscopy drainage, a single 10F PS resulted in overall clinical success rate of 91% in the endoscopy group, although 50% of the patients required re-endoscopic lavage or necrosectomy for secondary infection. 6,17,31,32 As a general recommendation, two stents (7-10 F) should be placed (►Table 2).…”

Section: Statement 6 Antibiotic Prophylaxis Is Recommended Prior To Drainage Of Pancreatic Fluid Collectionmentioning

confidence: 99%

“…21,22 Current recommendations from expert consensus guidelines suggest the use of prophylactic intravenous antibiotics having broad spectrum coverage but the duration of antibiotic therapy is unclear. 24 The caliber of double pig tail stent used ranges from 7 to 10F and the median number of stents used varies from 1 to 4. [25][26][27][28][29] Till date no randomized studies have addressed the optimal number of PS that should be inserted for drainage of a PFC.…”

Section: Statement 6 Antibiotic Prophylaxis Is Recommended Prior To Drainage Of Pancreatic Fluid Collectionmentioning

confidence: 99%

Endoscopic Management of Pancreatic Fluid Collections: Guidelines of Society of Gastrointestinal Endoscopy of India and Indian EUS Club

Shah

Basha

Rana

et al. 2021

Journal of Digestive Endoscopy

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Multicenter study of plastic vs. self-expanding metal stents in endoscopic ultrasound-guided drainage of walled-off pancreatic necrosis – PROMETHEUS: a randomized controlled trial protocol

Cited by 12 publications

References 29 publications

Comparison of lumen-apposing metal stents versus double-pigtail plastic stents for infected necrotising pancreatitis

Comparison of lumen-apposing metal stents versus double-pigtail plastic stents for infected necrotising pancreatitis

Head‐to‐head comparison between endoscopic ultrasound guided lumen apposing metal stent and plastic stents for the treatment of pancreatic fluid collections: A systematic review and meta‐analysis

Endoscopic Management of Pancreatic Fluid Collections: Guidelines of Society of Gastrointestinal Endoscopy of India and Indian EUS Club

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