Corresponding Author: Hiroki Yamaue, MD, Second Department of Surgery, Wakayama Medical University, Kimiidera, Wakayama 641-8510, Japan (yamaue-h@wakayama-med.ac.jp).
Accepted for Publication: December 8, 2020.
Published Online: March 3, 2021. doi:10.1001/jamasurg.2021.0108
Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2021 Yamada S et al. JAMA Surgery.
Author Contributions: Dr Yamaue had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Drs Yamada and Fujii contributed equally.
Concept and design: Yamada, Fujii, Sonohara, Kawai, Baba, Satoi, Sho, Takeda, Shimokawa, Yamaue.
Acquisition, analysis, or interpretation of data: Yamada, Fujii, Sonohara, Shibuya, Matsumoto, Fukuzawa, Aoki, Unno, Satoi, Kishi, Hatano, Uemura, Horiguchi, Sho, Takeda, Shimokawa, Kodera, Yamaue.
Drafting of the manuscript: Yamada, Fujii, Sho, Takeda, Shimokawa, Yamaue.
Critical revision of the manuscript for important intellectual content: Fujii, Sonohara, Kawai, Shibuya, Matsumoto, Fukuzawa, Baba, Aoki, Unno, Satoi, Kishi, Hatano, Uemura, Horiguchi, Sho, Takeda, Shimokawa, Kodera, Yamaue.
Statistical analysis: Yamada, Kawai, Uemura, Shimokawa.
Obtained funding: Sonohara.
Administrative, technical, or material support: Fujii, Shibuya, Fukuzawa, Baba, Unno, Satoi, Hatano, Uemura, Horiguchi, Sho, Takeda, Yamaue.
Supervision: Fujii, Unno, Uemura, Sho, Takeda, Kodera, Yamaue.
Conflict of Interest Disclosures: Dr Unno reported grants from Taiho, Takeda, Chugai, Yakult, and Asahi Kasei outside the submitted work. Dr Kodera reported grants from Johnson & Johnson and Covidien outside the submitted work. No other disclosures were reported.
Funding/Support: The COSMOS-DP trial was funded by Wakayama Medical University.
Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Data Sharing Statement: See Supplement 3.
Additional Contributions: We thank Yuzo Yamamoto, MD (Akita University), Yasutsugu Takada, MD (Ehime University), and Yoshitsugu Tajima, MD (Shimane University), for data and safety monitoring, and Yasuyuki Suzuki, MD (Kagawa University), and Masaji Tani, MD (Shiga Medical University), for central judgment. We thank Mariko Doi and Megumi Kitayama in the Clinical Study Support Center, Wakayama Medical University, for preparing this protocol. No compensation was received. We thank Jane Charbonneau, DVM, from Edanz Group for editing a draft of this manuscript; compensation was received.
1.Oláh
A , Issekutz
A , Belágyi
T , Hajdú
N , Romics
L
Jr . Randomized clinical trial of techniques for closure of the pancreatic remnant following distal pancreatectomy.
Br J Surg. 2009;96(6):602-607. doi:
10.1002/bjs.6620PubMedGoogle ScholarCrossref 4.Frozanpor
F , Lundell
L , Segersvärd
R , Arnelo
U . The effect of prophylactic transpapillary pancreatic stent insertion on clinically significant leak rate following distal pancreatectomy: results of a prospective controlled clinical trial.
Ann Surg. 2012;255(6):1032-1036. doi:
10.1097/SLA.0b013e318251610fPubMedGoogle ScholarCrossref 5.Carter
TI , Fong
ZV , Hyslop
T ,
et al. A dual-institution randomized controlled trial of remnant closure after distal pancreatectomy: does the addition of a falciform patch and fibrin glue improve outcomes?
J Gastrointest Surg. 2013;17(1):102-109. doi:
10.1007/s11605-012-1963-xPubMedGoogle ScholarCrossref 6.Montorsi
M , Zerbi
A , Bassi
C , Capussotti
L , Coppola
R , Sacchi
M ; Italian Tachosil Study Group. Efficacy of an absorbable fibrin sealant patch (TachoSil) after distal pancreatectomy: a multicenter, randomized, controlled trial.
Ann Surg. 2012;256(5):853-859. doi:
10.1097/SLA.0b013e318272dec0PubMedGoogle ScholarCrossref 8.Sa Cunha
A , Carrere
N , Meunier
B ,
et al; French Fédération de Recherche EN Chirurgie (FRENCH). Stump closure reinforcement with absorbable fibrin collagen sealant sponge (TachoSil) does not prevent pancreatic fistula after distal pancreatectomy: the FIABLE multicenter controlled randomized study.
Am J Surg. 2015;210(4):739-748. doi:
10.1016/j.amjsurg.2015.04.015PubMedGoogle ScholarCrossref 9.Kawai
M , Hirono
S , Okada
K ,
et al. Randomized controlled trial of pancreaticojejunostomy versus stapler closure of the pancreatic stump during distal pancreatectomy to reduce pancreatic fistula.
Ann Surg. 2016;264(1):180-187. doi:
10.1097/SLA.0000000000001395PubMedGoogle ScholarCrossref 13.Tarvainen
T , Sirén
J , Kokkola
A , Sallinen
V . Effect of hydrocortisone vs pasireotide on pancreatic surgery complications in patients with high risk of pancreatic fistula: a randomized clinical trial.
JAMA Surg. 2020;155(4):291-298. doi:
10.1001/jamasurg.2019.6019PubMedGoogle ScholarCrossref 17.Yamada
S , Fujii
T , Kawai
M ,
et al. Splenic vein resection together with the pancreatic parenchyma versus separated resection after isolation of the parenchyma during distal pancreatectomy (COSMOS-DP trial): study protocol for a randomised controlled trial.
Trials. 2018;19(1):369. doi:
10.1186/s13063-018-2756-7PubMedGoogle ScholarCrossref 22.Dedania
N , Agrawal
N , Winter
JM ,
et al. Splenic vein thrombosis is associated with an increase in pancreas-specific complications and reduced survival in patients undergoing distal pancreatectomy for pancreatic exocrine cancer.
J Gastrointest Surg. 2013;17(8):1392-1398. doi:
10.1007/s11605-013-2260-zPubMedGoogle ScholarCrossref 23.Kang
CM , Chung
YE , Jung
MJ , Hwang
HK , Choi
SH , Lee
WJ . Splenic vein thrombosis and pancreatic fistula after minimally invasive distal pancreatectomy.
Br J Surg. 2014;101(2):114-119. doi:
10.1002/bjs.9366PubMedGoogle ScholarCrossref