Comparison Between Two Methods of Pancreatic Transection in Distal Pancreatectomy

Pancreatic Fistula Clinical Trial

— TRUDY  

Official title:

Tri Stapler vs. Ultrasonic Scalpel in Distal Pancreatectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03880773
• Other study ID #: TRUDY
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2019
• Source: Azienda Ospedaliera Universitaria Integrata Verona
• Contact: Erica Secchettin
• Phone: 0458126254
• Email: erica.secchettin[@]aovr.veneto.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Several systematic reviews have investigated the management of the pancreatic stump in order to reduce the postoperative pancreatic fistula (POPF) rate after distal pancreatectomy (DP). The appropriate closure technique of the pancreatic stump is still debated. There is no published experience about the comparison of the Endo GIA Reinforced Reload with Tri-Staple Technology (TS) versus Harmonic Focus (US) after distal pancreatectomy (DP) regarding the reduction of POPF.

The investigators want to compare the incidence of clinically-relevant POPF (CR-POPF) after DP, depending upon the transection technique (TS versus US).

This is a randomized controlled, multicenter, patient-blinded, superiority trial. This protocol was designed according to the SPIRIT guidelines.

Two groups of 76 patients (152 in total) with an indication for elective minimally invasive or open DP for a lesion of the body-tail of the pancreas. The two techniques analyzed are Endo GIA Reinforced Reload with Tri-Staple Technology (TS) and Harmonic Focus (US) as control.

The primary endpoint is to evaluate the incidence of CR-POPF rate after DP. Secondary endpoints are intraoperative outcomes (blood loss, operative time and conversion of the minimally invasive procedure), postoperative outcomes (complications rate; hospitalization parameters to 90 days; mortality) and treatment costs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Scheduled for elective DP via a minimally invasive (laparoscopic or robotic) or open technique, either preserving the spleen or with splenectomy, depending on the diagnosis/nature of the tumor

• ASA score < 4

• Ability of the subject to understand character and individual consequences of the clinical trial

• Written informed consent

Exclusion Criteria:

• Pancreas thickness >17mm measured at the intraoperative ultrasound at the pancreatic transection level

• Metastatic disease

• Kidney or adrenal gland resection

• Arterial resection (celiac axis, superior mesenteric artery, hepatic artery)

• Intestinal resections and anastomoses or stoma

• Acute necrotizing and chronic pancreatitis

• Immune suppressed patients

• Pregnant women

• Patients with contraindications for distal pancreatectomy

• Impaired mental state or language problems

Related Conditions & MeSH terms

• Distal Pancreatectomy
• Fistula
• Pancreatic Fistula

Intervention

Device:
• Stapler
for transection of the pancreas and pancreatic stump treatment
• ultrasonic shears
for transection of the pancreas and pancreatic stump treatment

Locations

Country	Name	City	State
Italy	Ospedale Policlinico GB Rossi	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Integrata Verona

Country where clinical trial is conducted

Italy, 

References & Publications (8)

Ban D, Shimada K, Konishi M, Saiura A, Hashimoto M, Uesaka K. Stapler and nonstapler closure of the pancreatic remnant after distal pancreatectomy: multicenter retrospective analysis of 388 patients. World J Surg. 2012 Aug;36(8):1866-73. doi: 10.1007/s00268-012-1595-z. — View Citation

Diener MK, Seiler CM, Rossion I, Kleeff J, Glanemann M, Butturini G, Tomazic A, Bruns CJ, Busch OR, Farkas S, Belyaev O, Neoptolemos JP, Halloran C, Keck T, Niedergethmann M, Gellert K, Witzigmann H, Kollmar O, Langer P, Steger U, Neudecker J, Berrevoet F, Ganzera S, Heiss MM, Luntz SP, Bruckner T, Kieser M, Büchler MW. Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial. Lancet. 2011 Apr 30;377(9776):1514-22. doi: 10.1016/S0140-6736(11)60237-7. — View Citation

Kim H, Jang JY, Son D, Lee S, Han Y, Shin YC, Kim JR, Kwon W, Kim SW. Optimal stapler cartridge selection according to the thickness of the pancreas in distal pancreatectomy. Medicine (Baltimore). 2016 Aug;95(35):e4441. doi: 10.1097/MD.0000000000004441. — View Citation

Kleeff J, Diener MK, Z'graggen K, Hinz U, Wagner M, Bachmann J, Zehetner J, Müller MW, Friess H, Büchler MW. Distal pancreatectomy: risk factors for surgical failure in 302 consecutive cases. Ann Surg. 2007 Apr;245(4):573-82. — View Citation

Knaebel HP, Diener MK, Wente MN, Büchler MW, Seiler CM. Systematic review and meta-analysis of technique for closure of the pancreatic remnant after distal pancreatectomy. Br J Surg. 2005 May;92(5):539-46. Review. — View Citation

Peng YP, Zhu XL, Yin LD, Zhu Y, Wei JS, Wu JL, Miao Y. Risk factors of postoperative pancreatic fistula in patients after distal pancreatectomy: a systematic review and meta-analysis. Sci Rep. 2017 Mar 15;7(1):185. doi: 10.1038/s41598-017-00311-8. Review. — View Citation

Suzuki Y, Fujino Y, Tanioka Y, Hori Y, Ueda T, Takeyama Y, Tominaga M, Ku Y, Yamamoto YM, Kuroda Y. Randomized clinical trial of ultrasonic dissector or conventional division in distal pancreatectomy for non-fibrotic pancreas. Br J Surg. 1999 May;86(5):608-11. — View Citation

Zhang H, Zhu F, Shen M, Tian R, Shi CJ, Wang X, Jiang JX, Hu J, Wang M, Qin RY. Systematic review and meta-analysis comparing three techniques for pancreatic remnant closure following distal pancreatectomy. Br J Surg. 2015 Jan;102(1):4-15. doi: 10.1002/bjs.9653. Epub 2014 Nov 12. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Pancreatic fistula	pancreatic fistula according to International Study Group of Pancreatic Surgery (ISGPS) 2017 definition	90 days
Secondary	Operative time		intra-operatively
Secondary	Rate of postoperative overall and specific complications	abdominal collections, delayed gastric emptying, hemorrhage, sepsis, wound infections	30 days, 90 days
Secondary	Rate of re-operations or percutaneous drainage	re-operations rate or percutaneous drainage rate	30 days, 90 days
Secondary	Cost-analysis	intra and post-operative costs	90 days