A randomized controlled trial of stapled versus ultrasonic transection in distal pancreatectomy.


Journal

Surgical endoscopy
ISSN: 1432-2218
Titre abrégé: Surg Endosc
Pays: Germany
ID NLM: 8806653

Informations de publication

Date de publication:
06 2022
Historique:
received: 29 03 2021
accepted: 30 08 2021
pubmed: 15 9 2021
medline: 14 5 2022
entrez: 14 9 2021
Statut: ppublish

Résumé

The pancreatic transection method during distal pancreatectomy is thought to influence postoperative fistula rates. Yet, the optimal technique for minimizing fistula occurrence is still unclear. The present randomized controlled trial compared stapled versus ultrasonic transection in elective distal pancreatectomy. Patients undergoing distal pancreatectomy from July 2018 to July 2020 at two high-volume institutions were considered for inclusion. Exclusion criteria were contiguous organ resection and a parenchymal thickness > 17 mm on intraoperative ultrasound. Eligible patients were randomized in a 1:1 ratio to stapled transection (Endo GIA Reinforced Reload with Tri-Staple Technology®) or ultrasonic transection (Harmonic Focus® + or Harmonic Ace® + shears). The primary endpoint was postoperative pancreatic fistula. Secondary endpoints included overall complications, abdominal collections, and length of hospital stay. Overall, 72 patients were randomized in the stapled transection arm and 73 patients in the ultrasonic transection arm. Postoperative pancreatic fistula occurred in 23 patients (16%), with a comparable incidence between groups (12% in stapled transection versus 19% in ultrasonic dissection arm, p = 0.191). Overall complications did not differ substantially (35% in stapled transection versus 44% in ultrasonic transection arm, p = 0.170). There was an increased incidence of abdominal collections in the ultrasonic dissection group (32% versus 14%, p = 0.009), yet the need for percutaneous drain did not differ between randomization arms (p = 0.169). The median length of stay was 8 days in both groups (p = 0.880). Intraoperative blood transfusion was the only factor independently associated with postoperative pancreatic fistula on logistic regression analysis (OR 4.8, 95% CI 1.2-20.0, p = 0.032). The present randomized controlled trial of stapled versus ultrasonic transection in elective distal pancreatectomy demonstrated no significant difference in postoperative pancreatic fistula rates and no substantial clinical impact on other secondary endpoints.

Sections du résumé

BACKGROUND
The pancreatic transection method during distal pancreatectomy is thought to influence postoperative fistula rates. Yet, the optimal technique for minimizing fistula occurrence is still unclear. The present randomized controlled trial compared stapled versus ultrasonic transection in elective distal pancreatectomy.
METHODS
Patients undergoing distal pancreatectomy from July 2018 to July 2020 at two high-volume institutions were considered for inclusion. Exclusion criteria were contiguous organ resection and a parenchymal thickness > 17 mm on intraoperative ultrasound. Eligible patients were randomized in a 1:1 ratio to stapled transection (Endo GIA Reinforced Reload with Tri-Staple Technology®) or ultrasonic transection (Harmonic Focus® + or Harmonic Ace® + shears). The primary endpoint was postoperative pancreatic fistula. Secondary endpoints included overall complications, abdominal collections, and length of hospital stay.
RESULTS
Overall, 72 patients were randomized in the stapled transection arm and 73 patients in the ultrasonic transection arm. Postoperative pancreatic fistula occurred in 23 patients (16%), with a comparable incidence between groups (12% in stapled transection versus 19% in ultrasonic dissection arm, p = 0.191). Overall complications did not differ substantially (35% in stapled transection versus 44% in ultrasonic transection arm, p = 0.170). There was an increased incidence of abdominal collections in the ultrasonic dissection group (32% versus 14%, p = 0.009), yet the need for percutaneous drain did not differ between randomization arms (p = 0.169). The median length of stay was 8 days in both groups (p = 0.880). Intraoperative blood transfusion was the only factor independently associated with postoperative pancreatic fistula on logistic regression analysis (OR 4.8, 95% CI 1.2-20.0, p = 0.032).
CONCLUSION
The present randomized controlled trial of stapled versus ultrasonic transection in elective distal pancreatectomy demonstrated no significant difference in postoperative pancreatic fistula rates and no substantial clinical impact on other secondary endpoints.

Identifiants

pubmed: 34518950
doi: 10.1007/s00464-021-08724-3
pii: 10.1007/s00464-021-08724-3
pmc: PMC9085691
doi:

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

4033-4041

Informations de copyright

© 2021. The Author(s).

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Auteurs

Luca Landoni (L)

Unit of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.

Matteo De Pastena (M)

Unit of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.

Martina Fontana (M)

Unit of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.

Giuseppe Malleo (G)

Unit of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.

Alessandro Esposito (A)

Unit of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.

Luca Casetti (L)

Unit of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.

Giovanni Marchegiani (G)

Unit of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.

Massimiliano Tuveri (M)

Unit of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.

Salvatore Paiella (S)

Unit of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.

Antonio Pea (A)

Unit of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.

Marco Ramera (M)

Unit of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.

Alex Borin (A)

Unit of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.

Alessandro Giardino (A)

Unit of HPB Surgery, Pederzoli Hospital, Peschiera del Garda, Italy.

Isabella Frigerio (I)

Unit of HPB Surgery, Pederzoli Hospital, Peschiera del Garda, Italy.

Roberto Girelli (R)

Unit of HPB Surgery, Pederzoli Hospital, Peschiera del Garda, Italy.

Claudio Bassi (C)

Unit of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.

Giovanni Butturini (G)

Unit of HPB Surgery, Pederzoli Hospital, Peschiera del Garda, Italy.

Roberto Salvia (R)

Unit of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy. roberto.salvia@univr.it.
Unit of General and Pancreatic Surgery, G.B. Rossi Hospital, University of Verona - DSCOMI, P.Le Scuro 10, 37134, Verona, Italy. roberto.salvia@univr.it.

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