Incidence of Duodenal Stump Fistula After Gastrectomy for Gastric Cancer. A Randomized Controlled Trial

NCT03277144 | Unknown DMC FDA Device

• 1 other identifier: DRTST.01
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this trial is to demonstrate that the use of Tri-Staple Technology for duodenal resection during open gastrectomy for cancer is safer than the use of other conventional methods of resection/closure of the duodenum and that the incidence of duodenal fistula can be decreased to that observed after the use of this technology in Laparoscopic and robotic gastrectomy, therefore almost three times lower than that currently reported in literature. Participating centres must have an annual volume of at least 20 gastrectomies per year.

Conditions

Gastric Cancer; Duodenal Stump Leak

Keywords

linear stapler

Outcome Measures

Primary Outcomes (1)

• incidence of duodenal stump leak

  The aim of this study is to evaluate if duodenal stump closure using tri-staple technology can significantly decrease the incidence of duodenal stump leakage to 1% as compared to other conventional methods (5%). So the primary endpoint is : \- incidence of DSF, diagnosed on the basis of the presence of duodenal juice in the surgical drainage or its leakage through the abdominal wall, and confirmed by CT scan and/or fistulography.

  within 30/60 days from operation

Secondary Outcomes (7)

• cost of surgery

  within 90 days from operation

• operative time for duodenal stump closure

  intraopeartively

• short-term postoperative complications

  within 30 days from operation

• blood loss

  intraopeartively

• lenght of hospitalization

  120 days after operation

Study Arms (2)

TST-TriStaple(3lines stapler)Technology

EXPERIMENTAL

During gastrectomy for gatric cancer without anastomosis with the duodenum, Duodenal Stump is closed with a TriStaple (three-lines linear stapler) Technology device.

Device: TST-TriStaple(3lines stapler)Technology

OCT (other conventional techniques)

ACTIVE COMPARATOR

During gastrectomy for gatric cancer without anastomosis with the duodenum, Duodenal Stump is closed with conventional techniques including manual sutures and devices with only two lines of staples.

Other: other conventional techniques

Interventions

TST-TriStaple(3lines stapler)Technology DEVICE

Duodenal stump closed using a Tristaple ( three-lines linear stapler) device

TST-TriStaple(3lines stapler)Technology

other conventional techniques OTHER

Duodenal stump closed using other conventional techniques entailing manual suture or mechanical devices with only two lines of sutures.

Also known as: double-line linear stapler with manual reinforcement, manual suture, purse string suture, double-line linear stapler without manual reinforcement

OCT (other conventional techniques)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pathologically proven malign tumor of the stomach
• age of 18 to 80 years,
• no history of other cancers
• no history of radiotherapy in supra-mesocolic space
• total or distal gastrectomy without anastomosis with the duodenum

You may not qualify if:

• emergency surgery
• American Society of Anesthesiologists class \> 3
• need for combined resection of other organs
• laparoscopic/robotic access
• severe heart disease
• liver cirrhosis
• T stage \>cT4a
• citology positive at preoperative laparoscopy
• cM+ (clinical suspicion of distant metastasis)
• cD+ (clinical suspicion of duodenal involvment)

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

San Luigi University Hospital

Orbassano, Turin, Italy

RECRUITING

Related Publications (20)

• Inghelmann R, Grande E, Francisci S, Verdecchia A, Micheli A, Baili P, Capocaccia R, De Angelis R. Regional estimates of stomach cancer burden in Italy. Tumori. 2007 Jul-Aug;93(4):367-73. doi: 10.1177/030089160709300407.

  PMID: 17899867 BACKGROUND

• Aurello P, Bellagamba R, Rossi Del Monte S, D'Angelo F, Nigri G, Cicchini C, Ravaioli M, Ramacciato G. Apoptosis and microvessel density in gastric cancer: correlation with tumor stage and prognosis. Am Surg. 2009 Dec;75(12):1183-8.

  PMID: 19999909 BACKGROUND

• Aurello P, Magistri P, Nigri G, Petrucciani N, Novi L, Antolino L, D'Angelo F, Ramacciato G. Surgical management of microscopic positive resection margin after gastrectomy for gastric cancer: a systematic review of gastric R1 management. Anticancer Res. 2014 Nov;34(11):6283-8.

  PMID: 25368226 BACKGROUND

• Martin RC 2nd, Jaques DP, Brennan MF, Karpeh M. Achieving RO resection for locally advanced gastric cancer: is it worth the risk of multiorgan resection? J Am Coll Surg. 2002 May;194(5):568-77. doi: 10.1016/s1072-7515(02)01116-x.

  PMID: 12025834 BACKGROUND

• Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008 Nov 11;337:a2390. doi: 10.1136/bmj.a2390.

  PMID: 19001484 BACKGROUND

• Orsenigo E, Bissolati M, Socci C, Chiari D, Muffatti F, Nifosi J, Staudacher C. Duodenal stump fistula after gastric surgery for malignancies: a retrospective analysis of risk factors in a single centre experience. Gastric Cancer. 2014 Oct;17(4):733-44. doi: 10.1007/s10120-013-0327-x. Epub 2014 Jan 8.

  PMID: 24399492 RESULT

• Cozzaglio L, Coladonato M, Biffi R, Coniglio A, Corso V, Dionigi P, Gianotti L, Mazzaferro V, Morgagni P, Rosa F, Rosati R, Roviello F, Doci R. Duodenal fistula after elective gastrectomy for malignant disease : an italian retrospective multicenter study. J Gastrointest Surg. 2010 May;14(5):805-11. doi: 10.1007/s11605-010-1166-2. Epub 2010 Feb 9.

  PMID: 20143272 RESULT

• Rossi JA, Sollenberger LL, Rege RV, Glenn J, Joehl RJ. External duodenal fistula. Causes, complications, and treatment. Arch Surg. 1986 Aug;121(8):908-12. doi: 10.1001/archsurg.1986.01400080050009.

  PMID: 3729708 RESULT

• EDMUNDS LH Jr, WILLIAMS GM, WELCH CE. External fistulas arising from the gastro-intestinal tract. Ann Surg. 1960 Sep;152(3):445-71. doi: 10.1097/00000658-196009000-00009. No abstract available.

  PMID: 13725742 RESULT

• Tarazi R, Coutsoftides T, Steiger E, Fazio VW. Gastric and duodenal cutaneous fistulas. World J Surg. 1983 Jul;7(4):463-73. doi: 10.1007/BF01655935. No abstract available.

  PMID: 6624121 RESULT

• Kim W, Kim HH, Han SU, Kim MC, Hyung WJ, Ryu SW, Cho GS, Kim CY, Yang HK, Park DJ, Song KY, Lee SI, Ryu SY, Lee JH, Lee HJ; Korean Laparo-endoscopic Gastrointestinal Surgery Study (KLASS) Group. Decreased Morbidity of Laparoscopic Distal Gastrectomy Compared With Open Distal Gastrectomy for Stage I Gastric Cancer: Short-term Outcomes From a Multicenter Randomized Controlled Trial (KLASS-01). Ann Surg. 2016 Jan;263(1):28-35. doi: 10.1097/SLA.0000000000001346.

  PMID: 26352529 RESULT

• Pedrazzani C, Marrelli D, Rampone B, De Stefano A, Corso G, Fotia G, Pinto E, Roviello F. Postoperative complications and functional results after subtotal gastrectomy with Billroth II reconstruction for primary gastric cancer. Dig Dis Sci. 2007 Aug;52(8):1757-63. doi: 10.1007/s10620-006-9655-6. Epub 2007 Apr 3.

  PMID: 17404848 RESULT

• McCulloch P, Ward J, Tekkis PP; ASCOT group of surgeons; British Oesophago-Gastric Cancer Group. Mortality and morbidity in gastro-oesophageal cancer surgery: initial results of ASCOT multicentre prospective cohort study. BMJ. 2003 Nov 22;327(7425):1192-7. doi: 10.1136/bmj.327.7425.1192.

  PMID: 14630753 RESULT

• Cozzaglio L, Cimino M, Mauri G, Ardito A, Pedicini V, Poretti D, Brambilla G, Sacchi M, Melis A, Doci R. Percutaneous transhepatic biliary drainage and occlusion balloon in the management of duodenal stump fistula. J Gastrointest Surg. 2011 Nov;15(11):1977-81. doi: 10.1007/s11605-011-1668-6. Epub 2011 Sep 13.

  PMID: 21913043 RESULT

• Levy E, Cugnenc PH, Frileux P, Hannoun L, Parc R, Huguet C, Loygue J. Postoperative peritonitis due to gastric and duodenal fistulas. Operative management by continuous intraluminal infusion and aspiration: report of 23 cases. Br J Surg. 1984 Jul;71(7):543-6. doi: 10.1002/bjs.1800710725.

  PMID: 6733430 RESULT

• Isik B, Yilmaz S, Kirimlioglu V, Sogutlu G, Yilmaz M, Katz D. A life-saving but inadequately discussed procedure: tube duodenostomy. Known and unknown aspects. World J Surg. 2007 Aug;31(8):1616-24; discussion 1625-6. doi: 10.1007/s00268-007-9114-3.

  PMID: 17566821 RESULT

• Chander J, Lal P, Ramteke VK. Rectus abdominis muscle flap for high-output duodenal fistula: novel technique. World J Surg. 2004 Feb;28(2):179-82. doi: 10.1007/s00268-003-7017-5. Epub 2004 Jan 20.

  PMID: 14727065 RESULT

• Ujiki GT, Shields TW. Roux-en-Y operation in the management of postoperative fistula. Arch Surg. 1981 May;116(5):614-7. doi: 10.1001/archsurg.1981.01380170094017.

  PMID: 7235954 RESULT

• Milias K, Deligiannidis N, Papavramidis TS, Ioannidis K, Xiros N, Papavramidis S. Biliogastric diversion for the management of high-output duodenal fistula: report of two cases and literature review. J Gastrointest Surg. 2009 Feb;13(2):299-303. doi: 10.1007/s11605-008-0677-6. Epub 2008 Sep 30.

  PMID: 18825468 RESULT

• Musicant ME, Thompson JC. The emergency management of lateral duodenal fistula by pancreaticoduodenectomy. Surg Gynecol Obstet. 1969 Jan;128(1):108-14. No abstract available.

  PMID: 5774989 RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Maurizio Degiuli, MD Prof

  University of Turin, San Luigi University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rossella Reddavid, MD

CONTACT

+393479848651; rossella.reddavid@gmail.com

Andrea Evangelista

CONTACT

+390116336855; andre.evangelist@cpo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Head Surgical Oncology

Model Details: All gastric cancer patients who meet the inclusion/exclusion criteria and give the informed consent to participate are registered into the central trial database and centrally permuted-block randomized to one of the two arms (a. Duodenal Stump Closure with TriStaple Technology - TST or b. Duodenal Stump closure with other conventional techniques - OCT ).

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: September 8, 2017
• Study Start: September 11, 2017
• Primary Completion: September 11, 2018
• Study Completion: October 1, 2019
• Last Updated: September 18, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)