Total Pancreatectomy or High-risk Pancreatic Anastomosis After Pancreatoduodenectomy (TETRIS): a Randomized Controlled Trial

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Postoperative pancreatic fistula (POPF) is the main driver of surgical morbidity after pancreatoduodenectomy (PD). The aim of the present study is to compare total pancretectomy (TP) and primary pancreatic anastomosis (PA) in a cohort of extremely high-risk patients, with regards to postoperative outcomes and quality of life (QoL).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients older than 18 years

• All patients scheduled for PD for all kind of pancreatic diseases

• Patients able to give their informed consent

• Patients undergoing PD (Kausch-Whipple or Longmire-Traverso)

• Patients presenting two major and at least one minor criteria (Major criteria: Main pancreatic duct diameter ≤3mm; Soft pancreas. Minor criteria: Bleeding stump; Friable stump; Posterior/Eccentric duct; Invisible duct; Deep pancreas; Intraoperative acute pancreatitis; FRS 9-10)

• Two or more surgeons confirming eligibility

• PA or TP with or without spleen preservation (Kimura technique). These techniques are consistent with clinical practice; any other procedure will be a deviation from the protocol

Locations
Other Locations
Germany
Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital
NOT_YET_RECRUITING
Heidelberg
Department of General, Visceral, and Transplant Surgery, Ludwig-Maximilians-University Munich
NOT_YET_RECRUITING
Munich
Department of Surgery, Klinikum rechts der Isar, School of Medicine, Technical University of Munich
NOT_YET_RECRUITING
Munich
Italy
Pancreatic Surgery Unit, IRCCS Humanitas Research Hospital
NOT_YET_RECRUITING
Milan
Department of General and Pancreatic Surgery, The Pancreas Institute, University of Verona (Main Center)
RECRUITING
Verona
Contact Information
Primary
Giovanni Marchegiani, MD, PhD
giovanni.marchegiani@aovr.veneto.it
+ 39 0458126516
Time Frame
Start Date: 2021-10-21
Estimated Completion Date: 2025-12
Participants
Target number of participants: 98
Treatments
Active_comparator: Pancreatic anastomosis
Pancreatic anastomosis (PA) will be carried out according to the techniques adopted by the participating Centre, either pancreaticojejunostomy (PJ) (i.e. dunking PJ, Cattel-Warren duct-to-mucosa PJ, Blumgart PJ) or pancreatico-gastrostomy (PG) will be considered eligible. Any mitigation strategy (i.e. ETS, use of glues/biological matrices to protect the anastomosis, surgical feeding jejunostomy, prophylactic hydrocortisone/somatostatin administration) can be used according to the Center practice. The other two anastomosis, hepaticojejunostomy and duodenojejunostomy (in case of Longmire-Traverso pancreatoduodenectomy) or gastrojejunostomy (in case of Kausch-Whipple pancreatoduodenectomy), will be carried out as usual according to each Institution's operative standards.~At least one surgical drain will be placed in the retroperitoneum in all patients.
Experimental: Total pancreatectomy
Total pancreatectomy will be carried out according to each Institution's operative standards. Preservation of the spleen will be considered whenever possible according to Kimura technique. Either ligation or preservation of gastric vessels (right/left gastric artery/vein) will be allowed according to clinical necessity but will be recorded and correlated with postoperative outcomes. The reconstruction phase will be carried out according to each Institution's operative standards. One or more surgical drains can be left in place according to surgeon's preference.
Sponsors
Leads: Azienda Ospedaliera Universitaria Integrata Verona

This content was sourced from clinicaltrials.gov

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