PLASTIC STENT VS LUMEN APPOSING METAL STENTS IN ENDOSCOPIC ULTRASOUND-GUIDED DRAINAGE OF WALLED-OFF PANCREATIC NECROSIS: A MULTICENTRE RANDOMISED TRIAL (THE PROMETHEUS STUDY)

Aims Till date, there is not enough quality of evidence to recommend exclusively the use of LAMS. The main objective is to assess whether the theoretical benefit of LAMS is superior to DPS in the management of Walled-off necrosis (WON).

Methods This is a multicentre randomized controlled, prospective clinical trial with two parallel group. Primary endpoint is the short-term (4-weeks) clinical success determined by the reduction of the pancreatic collection (<50%or<5cm). Secondary endpoints: long-term clinical success (4-months); number of procedures; hospital stay, procedure duration, recurrence, safety and costs. A cross-over rescue is considered when initial protocol treatment fails

Fig. 1

Results Between June-2017 and October-2020, 99 patients were screened and 61 patients with WON were randomized and included for protocol analysis: 30 patients in LAMS group and 31 in DPS group. All included patients were followed up for a minimum of 12-month. Short-term clinical success was superior in LAMS-cohort, without significant difference (63%LAMS vs 45%DPS, p=0.154). Procedure duration (38 vs 53min, p<0.005) was significantly shorter in LAMS-cohort. Although, more additional and rescue procedures were needed in DPS cohort, it was non-significant. Length of hospital stay and stent-related adverse events (39%LAMS vs 45%DPS, p<0.641) were similar between cohorts Global success treatment (96-100%) was equal at the end of follow-up. ClinicalTrials.gov,NCT03100578

Table 1

	LAMS	DPP	p
Total SAES stent-related, n (%)	13 (39)	14 (45)	0.641
Fever, n(%)	4 (12)	11(35)
Bleeding,n(%)	6 (18)	4(13)

Conclusions Although the only significant difference between LAMS and DPS was the procedure duration, a greater number of additional and rescue procedures were required in the DPS-cohort; and short-term clinical success was higher in LAMS-group. The adverse event rate was considerable in both groups.

Publication History

Article published online:
14 April 2022