Feasibility of Pre-emptive VACStent Placement after Ivor Lewis Esophagectomy, to Prevent Anastomotic Leakage (PREVENT feasibility study)

Anastomotic leakage is a severe complication after esophagectomy, associated
with increased mortality, morbidity, and prolonged ICU- and in-hospital
stay.[1, 2] The incidence of anastomotic leakage of an intrathoracic
anastomosis ranges from 6 to 41%.[3] Patient-related prognostic factors for
development of anastomotic leakage include male gender, ASA score > III and
several comorbidities (e.g. diabetes mellitus, pulmonary and vascular
comorbidity).[4] At our hospital, endoscopic vacuum therapy (EVT) using a
polyurethane sponge (EsoSPONGE*; Braun B. Melsungen, Germany) was introduced as
primary treatment of anastomotic leakage after esophagectomy in 2018. EVT has
shown great efficacy and safety in patients with anastomotic leakage after
upper gastro-intestinal surgery, with success rates from 80 to 100% and adverse
event rates from 0 to 10% [5-8]. A recent development in the field of EVT is
the VACStent (MICRO-TECH Europe GmbH, Du*sseldorf, Germany): a fully covered
stent with a polyurethane sponge on its outer surface. The VACStent combines
the sealing effect of a stent with advantages of negative pressure wound
therapy, while the vacuum prevents dislocation of the stent. Furthermore,
contrary to the sponge that blocks the esophageal lumen, with the VACStent the
esophageal lumen remains open, allowing for oral intake. Literature on the
VACStent is scarce, but shows that this device is a feasible and effective
treatment for patients with post-surgical leakages, with successful and safe
application of EVT in 100% and a leakage closure rate of 80-100% [9, 10].
According to the adagium *prevention is better than cure*, we aim to reduce the
rate of anastomotic leakage after esophagectomy, to possibly prevent the
associated increased mortality, morbidity, and prolonged ICU- and in-hospital
stay. Placement of pre-emptive EVT directly following Ivor Lewis esophagectomy
could possibly reduce the risk of anastomotic leakage.[11] With a pre-emptive
VACStent, intake remains possible and the Enhanced Recovery After Surgery
(ERAS) protocol can be maintained. This clinical feasibility study is the first
to translate the use of the novel VACStent-device from *treatment* to
*prevention* of anastomotic leakage. It will combine the opportunities of our
unique large surgical volume, our extensive experience with EVT, and the novel
VACStent-device, which combines the advantages of EVT and covered stents. Based
on the results of this feasibility study, we will be able to design a
randomized controlled trial comparing rate of anastomotic leakage in patients
undergoing Ivor Lewis esophagectomy with gastric conduit reconstruction with or
without pre-emptive VACStent placement. References: 1. Fabbi M, Hagens ERC, van
Berge Henegouwen MI et al. Anastomotic leakage after esophagectomy for
esophageal cancer: definitions, diagnostics, and treatment. Dis Esophagus 2021;
34. doi:10.1093/dote/doaa039 2. Alanezi K, Urschel JD. Mortality secondary to
esophageal anastomotic leak. Ann Thorac Cardiovasc Surg 2004; 10: 71-75 3.
Gooszen JAH, Goense L, Gisbertz SS et al. Intrathoracic versus cervical
anastomosis and predictors of anastomotic leakage after oesophagectomy for
cancer. Br J Surg 2018; 105: 552-560. doi:10.1002/bjs.10728 4. van Kooten RT,
Voeten DM, Steyerberg EW et al. Patient-Related Prognostic Factors for
Anastomotic Leakage, Major Complications, and Short-Term Mortality Following
Esophagectomy for Cancer: A Systematic Review and Meta-Analyses. Ann Surg Oncol
2022; 29: 1358-1373. doi:10.1245/s10434-021-10734-3 5. Aziz M, Haghbin H,
Sharma S et al. Safety and effectiveness of endoluminal vacuum-assisted closure
for esophageal defects: Systematic review and meta-analysis. Endosc Int Open
2021; 9: E1371-E1380. doi:10.1055/a-1508-5947 6. Tavares G, Tustumi F, Tristao
LS et al. Endoscopic vacuum therapy for anastomotic leak in esophagectomy and
total gastrectomy: a systematic review and meta-analysis. Dis Esophagus 2021;
34: 1-10. doi:10.1093/dote/doaa132 7. Scognamiglio P, Reeh M, Karstens K et al.
Endoscopic vacuum therapy versus stenting for postoperative esophago-enteric
anastomotic leakage: systematic review and meta-analysis. Endoscopy 2020; 52:
632-642. doi:10.1055/a-1149-1741 8. do Monte Junior ES, de Moura DTH, Ribeiro
IB et al. Endoscopic vacuum therapy versus endoscopic stenting for upper
gastrointestinal transmural defects: Systematic review and meta-analysis. Dig
Endosc 2021; 33: 892-902. doi:10.1111/den.13813 9. Lange J, Kahler G, Bernhardt
J et al. The VACStent trial: combined treatment of esophageal leaks by covered
stent and endoscopic vacuum therapy. Surg Endosc 2023.
doi:10.1007/s00464-023-09861-7. doi:10.1007/s00464-023-09861-7 10. Pattynama
LMD, Eshuis WJ, van Berge Henegouwen MI et al. Vacuum-stent: A combination of
endoscopic vacuum therapy and an intraluminal stent for treatment of esophageal
transmural defects. Front Surg 2023; 10: 1145984.
doi:10.3389/fsurg.2023.1145984 11. Muller PC, Morell B, Vetter D et al.
Preemptive Endoluminal Vacuum Therapy to Reduce Morbidity After Minimally
Invasive Ivor Lewis Esophagectomy: Including a Novel Grading System for
Postoperative Endoscopic Assessment of GI-Anastomoses. Ann Surg 2021; 274:
751-757. doi:10.1097/SLA.0000000000005125 12. Verstegen MHP, Bouwense SAW, van
Workum F et al. Management of intrathoracic and cervical anastomotic leakage
after esophagectomy for esophageal cancer: a systematic review. World J Emerg
Surg 2019; 14: 17. doi:10.1186/s13017-019-0235-4 13. Chan SM, Auyeung KKY, Lam
SF et al. Current status in endoscopic management of upper gastrointestinal
perforations, leaks and fistulas. Dig Endosc 2022; 34: 43-62.
doi:10.1111/den.14061 14. Reimer S, Seyfried F, Flemming S et al. Evolution of
endoscopic vacuum therapy for upper gastrointestinal leakage over a 10-year
period: a quality improvement study. Surg Endosc 2022; 36: 9169-9178.
doi:10.1007/s00464-022-09400-w 15. Pattynama LMD, Pouw RE, van Berge Henegouwen
MI et al. Endoscopic vacuum therapy for anastomotic leakage after upper
gastrointestinal surgery. Submitted 2022. 16. Luttikhold J, Pattynama LMD,
Seewald S et al. Endoscopic Vacuum Therapy for Esophageal Perforation: A
Multicenter Retrospective Cohort Study. Endoscopy 2023.
doi:10.1055/a-2042-6707. doi:10.1055/a-2042-6707 17. Chon SH, Bartella I,
Burger M et al. VACStent: a new option for endoscopic vacuum therapy in
patients with esophageal anastomotic leaks after upper gastrointestinal
surgery. Endoscopy 2020; 52: E166-E167. doi:10.1055/a-1047-0244 18. Jung DH,
Huh CW, Min YW et al. Endoscopic vacuum therapy for the management of upper GI
leaks and perforations: a multicenter retrospective study of factors associated
with treatment failure (with video). Gastrointest Endosc 2022; 95: 281-290.
doi:10.1016/j.gie.2021.09.018 19. Muller PC, Vetter D, Kapp JR et al.
Pre-Emptive Endoluminal Negative Pressure Therapy at the Anastomotic Site in
Minimally Invasive Transthoracic Esophagectomy (the preSPONGE Trial): Study
Protocol for a Multicenter Randomized Controlled Trial. Int J Surg Protoc 2021;
25: 7-15. doi:10.29337/ijsp.24 20. de Moura DTH, de Moura B, Manfredi MA et al.
Role of endoscopic vacuum therapy in the management of gastrointestinal
transmural defects. World J Gastrointest Endosc 2019; 11: 329-344.
doi:10.4253/wjge.v11.i5.329 21. Kingma BF, Eshuis WJ, de Groot EM et al.
Paravertebral catheter versus EPidural analgesia in Minimally invasive
Esophageal resectioN: a randomized controlled multicenter trial (PEPMEN trial).
BMC Cancer 2020; 20: 142. doi:10.1186/s12885-020-6585-1 22. van der Werf LR,
Busweiler LAD, van Sandick JW et al. Reporting National Outcomes After
Esophagectomy and Gastrectomy According to the Esophageal Complications
Consensus Group (ECCG). Ann Surg 2020; 271: 1095-1101.
doi:10.1097/SLA.0000000000003210

We aim to evaluate the technical and logistic feasibility and safety of
pre-emptive VACStent placement in patients undergoing esophagectomy with
gastric conduit reconstruction, to prevent anastomotic leakage by early
endoscopic vacuum therapy (EVT). Outcomes of this study can then be used for
determination of a formal sample size required to design a larger clinical
trial: a randomized controlled trial of pre-emptive use of VACStent placement
after esophagectomy.

This is an investigator initiated, single-center, prospective, feasibility
study of pre-emptive VACStent placement after Ivor Lewis esophagectomy to
reduce the risk of anastomotic leakage.

Endoscopic placement of a pre-emptive VACStent, right after Ivor Lewis
esophagectomy in the operation room, and removal after 5-7 days.

Anastomotic leakage is a severe complication with an incidence up to 30%. This
complication is associated with severe morbidity, including prolonged (ICU-
and) hospital stay, multiple endoscopies or even re-operations, with possibly a
resection of the esophagus and therefore loss of continuity of the
gastro-intestinal tract. We expect the VACStent to reduce the risk of
anastomotic leakage in this patient group. Reduction of this risk would
therefore have great benefits. Treatment, diagnostics and follow-up will not
differ from the standard treatment protocol for the included patients. A
VACStent will be placed immediately after surgery during the same procedure and
5-7 days later an additional endoscopy will be performed. During this
endoscopy, the VACStent will be removed and the anastomosis will be evaluated.
An additional benefit is that any potential post-operative problems
irregularities regarding the anastomosis will be discovered earlier on. Apart
from the described additional interventions for placement and removal of the
VACStent, the standard treatment protocol will be followed.