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VESSEL PRE-SEALING IN THIRD SPACE ENDOSCOPY: A RANDOMIZED CONTROLLED TRIAL

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Introduction

Third-space endoscopy (TSE) is standard for treating neoplastic and motility disorders but is limited by intra-procedural bleeding. Vessel pre-sealing using electrocautery in an underwater setting may mitigate this, improving procedural safety and efficiency.

Aims & Methods

We conducted a randomized controlled trial (NCT05804266) comparing underwater (saline immersion) vs conventional CO₂-based coagulation during TSE procedures (ESD and POEM). Patients were randomized 1:1. The same electrosurgical settings (SWIFT COAG E3, 89 W for POEM and SWIFT COAG E4, 124 W for ESD) and instruments (VIO 3 and HybridKnife T-type, Erbe Elektromedizin GmbH, Tübingen, Germany) were used across arms. In the underwater group, vessels ≥1.2 mm were coagulated under saline immersion to enable pre-sealing; smaller vessels were treated conventionally. In the control group, all vessels were treated under CO₂, with vessel isolation when needed. Primary endpoint was the rate of intra-procedural bleeding requiring further hemostatic treatment (knife tip, coagulation forceps) of pre-sealed vessels. Secondary outcomes included other adverse events (ie delayed bleeding).

Results

Among 70 patients (37 underwater, 33 CO₂, no significant demographic difference including history of antiplatelet/anticoagulant therapy, discontinued in all patients on therapy), intra-procedural bleeding requiring hemostasis of pre-sealed vessels occurred in 12/37 (32.4%) underwater group vs 25/33 (75.8%) control (RR 0.43(0.26-0.71); NNT 2.3; P<0.01). In the underwater group, no patient required coagulation forceps; all bleedings were managed with the knife. In contrast, 9/33 (27.3%) control patients required forceps (RR: 0.05 (0.00-0.78); NNT 3.76 P<0.01). One intra-procedural perforation and two post-procedural adverse events (delayed bleeding and fever) occurred in the control group; none in the underwater arm (n.s). No mortality occurred.

Conclusion

Underwater (saline immersion) vessel pre-sealing significantly reduces the risk of intraprocedural bleeding and consequently the need of hemostatic devices, suggesting a safer, cost-effective alternative to conventional coagulation in TSE.