Total pancrEaTectomy vs High-Risk Pancreatic anastomosiS

NCT05212350 | Unknown

• 1 other identifier: TETRIS
• Study Type: interventional
• Target: 98
• Locations: 2 countries
• Sites: 5

Brief 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).

Conditions

Pancreatic Fistula

Keywords

Pancreatic fistula; High-risk pancreas; Pancreatoduodenectomy; Pancreatic anastomosis; Total pancreatectomy

Outcome Measures

Primary Outcomes (1)

• Major morbidity

  Rate of postoperative major morbidity, defined as Clavien-Dindo≥ 3.

  90 postoperative days.

Secondary Outcomes (16)

• Mortality

  90 postoperative days.

• Postoperative complications

  90 postoperative days.

• Postoperative morbidity

  90 postoperative days.

• Time-to-functional recovery.

  90 postoperative days.

• Length of hospital stay

  90 postoperative days.

Study Arms (2)

Pancreatic anastomosis

ACTIVE COMPARATOR

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.

Procedure: Pancreatic anastomosis

Total pancreatectomy

EXPERIMENTAL

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.

Procedure: Total pancreatectomy

Interventions

Total pancreatectomy PROCEDURE

Patients randomized to receive total pancreatectomy at the time of transection of the pancreas will undergo completion total pancreatectomy according to each Institution's operative standards.

Total pancreatectomy

Pancreatic anastomosis PROCEDURE

Patients randomized to receive pancreatic anastomosis at the time of transection of the pancreas will undergo pancreatico-jejunosomy or pancreatico-gastrostomy according to each Institution's operative standards.

Pancreatic anastomosis

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Informed consent withdrawal
• Impossibility to undergo surgery for any reason
• Main pancreatic duct of the pancreatic neck/body \>3mm at preoperative imaging (CT scan or MRI)
• PD not performed for any reason
• Absence of two major criteria
• Absence of at least one minor criteria
• Absence of interobserver agreement between at least 2 surgeons
• More than 1 extension of resection to pancreatic neck due to pancreatic margin positivity
• Wrong randomization

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (5)

Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital

Heidelberg, 69120, Germany

NOT YET RECRUITING

Department of General, Visceral, and Transplant Surgery, Ludwig-Maximilians-University Munich

Munich, 81377, Germany

NOT YET RECRUITING

Department of Surgery, Klinikum rechts der Isar, School of Medicine, Technical University of Munich

Munich, 81675, Germany

NOT YET RECRUITING

Department of General and Pancreatic Surgery, The Pancreas Institute, University of Verona (Main Center)

Verona, Veneto/Verona, 37134, Italy

RECRUITING

Pancreatic Surgery Unit, IRCCS Humanitas Research Hospital

Milan, 20089, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Pancreatic Fistula

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Pancreatic Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Roberto Salvia, MD, PhD

  Azienda Ospedaliera Universitaria Integrata di Verona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni Marchegiani, MD, PhD

CONTACT

+ 39 0458126516; giovanni.marchegiani@aovr.veneto.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 28, 2022
• Study Start: October 21, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2025
• Last Updated: January 28, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); IT (2)