Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

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

Authors: Suguru Yamada, Tsutomu Fujii, Manabu Kawai, Toshio Shimokawa, Masafumi Nakamura, Yoshiaki Murakami, Sohei Satoi, Hidetoshi Eguchi, Yuichi Nagakawa, Yasuhiro Kodera, Hiroki Yamaue

Published in: Trials | Issue 1/2018

Login to get access

Abstract

Background

In distal pancreatectomy (DP), it is customary to ligate and divide the splenic vein after isolating it from the pancreatic parenchyma. This is considered essential to prevent disruption of the stump of the splenic vein and consequent intra-abdominal haemorrhage in the event of pancreatic fistula (PF). However, this procedure can be technically demanding, especially when the vein is firmly embedded in the pancreatic parenchyma. The objective of the COSMOS-DP trial is to confirm the non-inferiority of resection of the splenic vein embedded in the pancreatic parenchyma compared with the conventional technique of isolating the splenic vein before resection during DP using a mechanical stapler.

Methods

Patients with diseases of the pancreatic body and tail whose pancreatic parenchyma and splenic vein can be divided concurrently during open or laparoscopic DP are considered eligible for inclusion. This study is designed as a multicentre prospective randomised phase III trial. Eligible patients will be centrally randomised to either Arm A (resection of the splenic vein after isolation from the pancreatic parenchyma) or Arm B (co-resection of the vein together with the pancreas). This study aims to establish the non-inferiority of the safety of Arm B compared with that of Arm A; the primary endpoint is the incidence of PF (ISGPF grade B/C).

Discussion

The COSMOS-DP trial will establish the safety of this procedure, such that it can be recommended with more confidence. The use of this procedure will likely result in significant reductions in operative time and blood loss during DP.

Trial registration

ClinicalTrials.gov, NCT02871804. Registered on 27 July 2016.
Appendix
Available only for authorised users
Literature
1.
Olah A, Issekutz A, Belagyi T, Hajdu N, Romics L Jr. Randomized clinical trial of techniques for closure of the pancreatic remnant following distal pancreatectomy. Br J Surg. 2009;96:602–7.CrossRefPubMed
2.
Diener MK, Seiler CM, Rossion I, Kleeff J, Glanemann M, Butturini G, et al. Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial. Lancet. 2011;377:1514–22.CrossRefPubMed
3.
Takahashi H, Ogawa H, Ohigashi H, Gotoh K, Yamada T, Ohue M, et al. Preoperative chemoradiation reduces the risk of pancreatic fistula after distal pancreatectomy for pancreatic adenocarcinoma. Surgery. 2011;150:547–56.CrossRefPubMed
4.
Frozanpor F, Lundell L, Segersvard 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;255:1032–6.CrossRefPubMed
5.
Carter TI, Fong ZV, Hyslop T, Lavu H, Tan WP, Hardacre J, 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;17:102–9.CrossRefPubMed
6.
Montorsi M, Zerbi A, Bassi C, Capussotti L, Coppola R, Sacchi M, et al. Efficacy of an absorbable fibrin sealant patch (TachoSil) after distal pancreatectomy: a multicenter, randomized, controlled trial. Ann Surg. 2012;256:853–9. discussion 9–60CrossRefPubMed
7.
Allen PJ, Gonen M, Brennan MF, Bucknor AA, Robinson LM, Pappas MM, et al. Pasireotide for postoperative pancreatic fistula. N Engl J Med. 2014;370:2014–22.CrossRefPubMed
8.
Sa Cunha A, Carrere N, Meunier B, Fabre JM, Sauvanet A, Pessaux P, et al. 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;210:739–48.CrossRefPubMed
9.
Shimizu S, Tanaka M, Konomi H, Mizumoto K, Yamaguchi K. Laparoscopic pancreatic surgery: current indications and surgical results. Surg Endosc. 2004;18:402–6.CrossRefPubMed
10.
Uyama I, Sugioka A, Sakurai Y, Komori Y, Hanai T, Matsui H, et al. Hand-assisted laparoscopic function- preserving and radical gastrectomies for advanced-stage proximal gastric cancer. J Am Coll Surg. 2004;199:508–15.CrossRefPubMed
11.
Nakamura M, Ueda J, Kohno H, Aly MY, Takahata S, Shimizu S, et al. Prolonged peri-firing compression with a linear stapler prevents pancreatic fistula in laparoscopic distal pancreatectomy. Surg Endosc. 2011;25:867–71.CrossRefPubMed
12.
Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, et al. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005;138:8–13.CrossRefPubMed
13.
Kawai M, Hirono S, Okada K, Sho M, Nakajima Y, Eguchi H, et al. Randomized controlled trial of pancreaticojejunostomy versus stapler closure of the pancreatic stump during distal pancreatectomy to reduce pancreatic fistula. Ann Surg. 2016;264:180–7.CrossRefPubMed
14.
Wente MN, Veit JA, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, et al. Postpancreatectomy hemorrhage (PPH): an international study Group of Pancreatic Surgery (ISGPS) definition. Surgery. 2007;142:20–5.CrossRefPubMed
15.
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240:205–13.CrossRefPubMedPubMedCentral
Metadata
Title
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
Authors
Suguru Yamada
Tsutomu Fujii
Manabu Kawai
Toshio Shimokawa
Masafumi Nakamura
Yoshiaki Murakami
Sohei Satoi
Hidetoshi Eguchi
Yuichi Nagakawa
Yasuhiro Kodera
Hiroki Yamaue
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2756-7

Other articles of this Issue 1/2018

Trials 1/2018 Go to the issue

Study protocol

Mechanochemical ablation versus cyanoacrylate adhesive for the treatment of varicose veins: study protocol for a randomised controlled trial

Study protocol

A recommender system to quit smoking with mobile motivational messages: study protocol for a randomized controlled trial

Study protocol

Does a Screening Trial for Spinal Cord Stimulation in Patients with Chronic Pain of Neuropathic Origin have Clinical Utility and Cost-Effectiveness? (TRIAL-STIM Study): study protocol for a randomised controlled trial

Study protocol

The effect of regularly dosed paracetamol versus no paracetamol on renal function in Plasmodium knowlesi malaria (PACKNOW): study protocol for a randomised controlled trial

Study protocol

Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART): study protocol for a randomized controlled trial

Study protocol

Study protocol for single-center, open-label, randomized controlled trial to clarify the preventive efficacy of electrical stimulation for muscle atrophy after trauma