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

Pancreatoduodenectomy with or without prophylactic falciform ligament wrap around the gastroduodenal artery stump for prevention of pancreatectomy hemorrhage

Authors: Benjamin Müssle, Leonie Zühlke, Ann Wierick, Dorothée Sturm, Xina Grählert, Marius Distler, Nuh N. Rahbari, Jürgen Weitz, Thilo Welsch

Published in: Trials | Issue 1/2018

Login to get access

Abstract

Background

The purpose of this study is to evaluate whether wrapping of the pedicled falciform ligamentum flap around the gastroduodenal artery (GDA) stump/hepatic artery can significantly decrease the incidence of erosion hemorrhage after pancreatoduodenectomy (PD).

Methods/design

This is a randomized controlled multicenter trial involving 400 patients undergoing PD. Patients will be randomized into two groups. The intervention group consists of 200 patients with a prophylactic wrapping of the GDA stump using the pedicled falciform ligament. The control group consists of 200 patients without the wrap. The primary endpoint is the rate of postoperative erosion hemorrhage of the GDA stump or hepatic artery within 3 months. The secondary endpoints are postpancreatectomy hemorrhage stratified according to the texture of the pancreas, postoperative pancreatic fistula (POPF), postoperative rate of therapeutic interventions, morbidity, and mortality.

Discussion

Only few retrospective studies investigated the effectiveness of a falciform ligament wrap around the GDA for prevention of erosion hemorrhage. Erosion hemorrhage occurs in up to 6–9% of cases after PD and is most frequently evoked by a POPF. Erosion hemorrhage is associated with a remarkable mortality of over 30%. The rate of hemorrhage after performing the wrap is reported to be low. However, there exist no prospectively controlled data to support its general use. Therefore, the presented randomized controlled trial will provide clinically relevant evidence of the effectiveness of the wrap with statistical significance.

Trial registration

clinicaltrials.gov, NCT02588066; Registered on 27 October 2015.
Appendix
Available only for authorised users
Literature
1.
Hartwig W, Hackert T, Hinz U, Hassenpflug M, Strobel O, Buchler MW, Werner J. Multivisceral resection for pancreatic malignancies: risk-analysis and long-term outcome. Ann Surg. 2009;250(1):81–7.CrossRefPubMed
2.
Tani M, Terasawa H, Kawai M, Ina S, Hirono S, Uchiyama K, Yamaue H. Improvement of delayed gastric emptying in pylorus-preserving pancreaticoduodenectomy: results of a prospective, randomized, controlled trial. Ann Surg. 2006;243(3):316–20.CrossRefPubMedPubMedCentral
3.
Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005;138(1):8–13.CrossRefPubMed
4.
Harnoss JC, Ulrich AB, Harnoss JM, Diener MK, Buchler MW, Welsch T. Use and results of consensus definitions in pancreatic surgery: a systematic review. Surgery. 2014;155(1):47–57.CrossRefPubMed
5.
Keck T, Wellner UF, Bahra M, Klein F, Sick O, Niedergethmann M, Wilhelm TJ, Farkas SA, Borner T, Bruns C, et al. Pancreatogastrostomy versus pancreatojejunostomy for RECOnstruction After PANCreatoduodenectomy (RECOPANC, DRKS 00000767): perioperative and long-term results of a multicenter randomized controlled trial. Ann Surg. 2016;263(3):440–9.CrossRefPubMedPubMedCentral
6.
Darnis B, Lebeau R, Chopin-Laly X, Adham M. Postpancreatectomy hemorrhage (PPH): predictors and management from a prospective database. Langenbecks Arch Surg. 2013;398(3):441–8.CrossRefPubMed
7.
Welsch T, Eisele H, Zschabitz S, Hinz U, Buchler MW, Wente MN. Critical appraisal of the International Study Group of Pancreatic Surgery (ISGPS) consensus definition of postoperative hemorrhage after pancreatoduodenectomy. Langenbecks Arch Surg. 2011;396(6):783–91.CrossRefPubMed
8.
Choi SH, Moon HJ, Heo JS, Joh JW, Kim YI. Delayed hemorrhage after pancreaticoduodenectomy. J Am Coll Surg. 2004;199(2):186–91.CrossRefPubMed
9.
Roulin D, Cerantola Y, Demartines N, Schafer M. Systematic review of delayed postoperative hemorrhage after pancreatic resection. J Gastrointest Surg. 2011;15(6):1055–62.CrossRefPubMed
10.
Ramia JM, de la Plaza R, Adel F, Ramiro C, Arteaga V, Garcia-Parreno J. Wrapping in pancreatic surgery: a systematic review. ANZ J Surg. 2014;84(12):921–4.CrossRefPubMed
11.
Sakamoto Y, Shimada K, Esaki M, Kajiwara T, Sano T, Kosuge T. Wrapping the stump of the gastroduodenal artery using the falciform ligament during pancreaticoduodenectomy. J Am Coll Surg. 2007;204(2):334–6.CrossRefPubMed
12.
Mussle B, Wierick A, Distler M, Weitz J, Welsch T. Falciform ligament wrap for prevention of gastroduodenal artery bleed after pancreatoduodenectomy. J Surg Res. 2017;207:215–22.CrossRefPubMed
13.
Wente MN, Veit JA, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, et al. Postpancreatectomy hemorrhage (PPH): an International Study Group of Pancreatic Surgery (ISGPS) definition. Surgery. 2007;142(1):20–5.CrossRefPubMed
14.
Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, et al. The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 years after. Surgery. 2017;161(3):584–91.CrossRefPubMed
15.
Weitz J, Koch M, Kleeff J, Muller MW, Schmidt J, Friess H, Buchler MW. Kausch-Whipple pancreaticoduodenectomy. Technique and results. Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen. 2004;75(11):1113–9.CrossRefPubMed
16.
Matsuda H, Sadamori H, Umeda Y, Shinoura S, Yoshida R, Satoh D, Utsumi M, Yagi T, Fujiwara T. Preventive effect of omental flap in pancreaticoduodenectomy against postoperative pseudoaneurysm formation. Hepato-Gastroenterology. 2012;59(114):578–83.PubMed
17.
Xu C, Yang X, Luo X, Shen F, Wu M, Tan W, Jiang X. “Wrapping the gastroduodenal artery stump” during pancreatoduodenectomy reduced the stump hemorrhage incidence after operation. Chin J Cancer Res. 2014;26(3):299–308.PubMedPubMedCentral
18.
Fischer RP, Gervin AS. The use of falciform ligament in the repair of hepatic injuries. Surg Gynecol Obstet. 1985;161(4):383–4.PubMed
19.
Costalat G, Alquier Y. Combined laparoscopic and endoscopic treatment of perforated gastroduodenal ulcer using the ligamentum teres hepatis (LTH). Surg Endosc. 1995;9(6):677–9. discussion 680CrossRefPubMed
20.
Hassenpflug M, Hartwig W, Strobel O, Hinz U, Hackert T, Fritz S, Buchler MW, Werner J. Decrease in clinically relevant pancreatic fistula by coverage of the pancreatic remnant after distal pancreatectomy. Surgery. 2012;152(3 Suppl 1):S164–71.CrossRefPubMed
21.
Hassenpflug M, Bruckner T, Knebel P, Diener MK, Buchler MW, Werner J. DISCOVER trial- distal resection of the pancreas with or without coverage of the pancreatic remnant: study protocol of a randomised controlled trial. Trials. 2013;14:430.CrossRefPubMedPubMedCentral
22.
de Castro SM, Kuhlmann KF, Busch OR, van Delden OM, Lameris JS, van Gulik TM, Obertop H, Gouma DJ. Delayed massive hemorrhage after pancreatic and biliary surgery: embolization or surgery? Ann Surg. 2005;241(1):85–91.PubMedPubMedCentral
23.
Yekebas EF, Wolfram L, Cataldegirmen G, Habermann CR, Bogoevski D, Koenig AM, Kaifi J, Schurr PG, Bubenheim M, Nolte-Ernsting C, et al. Postpancreatectomy hemorrhage: diagnosis and treatment: an analysis in 1669 consecutive pancreatic resections. Ann Surg. 2007;246(2):269–80.CrossRefPubMedPubMedCentral
24.
Fujii Y, Shimada H, Endo I, Yoshida K, Matsuo K, Takeda K, Ueda M, Morioka D, Tanaka K, Togo S. Management of massive arterial hemorrhage after pancreatobiliary surgery: does embolotherapy contribute to successful outcome? J Gastrointest Surg. 2007;11(4):432–8.CrossRefPubMedPubMedCentral
25.
Abe N, Sugiyama M, Yanagida O, Masaki T, Mori T, Atomi Y. Wrapping of skeletonized and divided vessels using the falciform ligament in distal pancreatectomy. Am J Surg. 2007;194(1):94–7.CrossRefPubMed
26.
Tani M, Kawai M, Hirono S, Hatori T, Imaizumi T, Nakao A, Egawa S, Asano T, Nagakawa T, Yamaue H. Use of omentum or falciform ligament does not decrease complications after pancreaticoduodenectomy: nationwide survey of the Japanese Society of Pancreatic Surgery. Surgery. 2012;151(2):183–91.CrossRefPubMed
Metadata
Title
Pancreatoduodenectomy with or without prophylactic falciform ligament wrap around the gastroduodenal artery stump for prevention of pancreatectomy hemorrhage
Authors
Benjamin Müssle
Leonie Zühlke
Ann Wierick
Dorothée Sturm
Xina Grählert
Marius Distler
Nuh N. Rahbari
Jürgen Weitz
Thilo Welsch
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2580-0

Other articles of this Issue 1/2018

Trials 1/2018 Go to the issue

Study protocol

Mobile Link – a theory-based messaging intervention for improving sexual and reproductive health of female entertainment workers in Cambodia: study protocol of a randomized controlled trial

Study protocol

An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for the process evaluation of a cluster randomised controlled feasibility trial

Study protocol

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

Study protocol

Gender-specific HIV and substance abuse prevention strategies for South African men: study protocol for a randomized controlled trial

Study protocol

Improved simplified clinical algorithm for identifying patients eligible for immediate initiation of antiretroviral therapy for HIV (SLATE II): protocol for a randomized evaluation

Study protocol

Antenatal sildenafil administration to prevent pulmonary hypertension in congenital diaphragmatic hernia (SToP-PH): study protocol for a phase I/IIb placenta transfer and safety study