Post-Operative Acute Pancreatitis After Pancreaticoduodenectomy

NCT04917172 | Completed DMC

• 1 other identifier: Prog. 2130CESC
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The occurrence of post-pancreatectomy acute pancreatitis (PPAP) can critically impact outcomes after pancreaticoduodenectomy. Although diagnosing a PPAP can be challenging, its identification appears crucial as it can trigger additional morbidity. However, due to the early onset in the perioperative period, the actual spectrum of its early phases has not been systematically explored yet. For this reason, the present study will compare some early biochemical evidence of pancreatic stump damage to morphological changes evident at postoperative imaging. The postoperative evaluation of serum and/or urine pancreatic enzymes and the radiologic assessment are included in everyday clinical practice. However, the timing and the clinical relevance of such findings mostly rely on the single-institution experience. This study aims to characterize PPAP by investigating its early radiologic, biochemical, and clinical spectrum of either local or systemic changes associated.

Conditions

Acute Pancreatitis; Pancreatic Fistula; Postoperative Complications

Keywords

PPAP, POH, pancreatoduodenectomy

Outcome Measures

Primary Outcomes (1)

• the difference in apparent diffusion coefficient (ADC) values at diffusion-weighted (DW) MRI in the PPAP group compared to patients without PPAP.

  DW-MRI studies will be performed on a 1.5 T scanner using a multi-channel phased-array torso coil.

  postoperative day 3 (72 h after the index surgery).

Secondary Outcomes (3)

• intraindividual correlation between longitudinal assessment of serum pancreatic enzymes

  5 days after surgery

• postoperative acute pancreatitis and morbidity

  90 days after surgery

• Postoperative acute pancreatitis incidence

  90 days after surgery

Study Arms (1)

Pancreaticoduodenectomy patients

Patients scheduled to receive elective Pancreaticoduodenectomy (PD) (according to Kausch-Whipple or Longmire-Traverso) for all kinds of pancreatic disease (benign, malignant or premalignant) will be enrolled, after having signed a proper informed consent. Each patient will undergo PD once checked the presence of a resectable mass as provided by the normal clinical practice through high-quality cross-sectional imaging. Pre-operative management will follow institutional standards, serum pancreatic amylase and lipase activity will be measured as a part of the standard pre-operative evaluation.

Diagnostic Test: postoperative acute pancreatitis evaluation

Interventions

postoperative acute pancreatitis evaluation DIAGNOSTIC_TEST

Surgical resection and reconstruction will be carried out according to the Institutional standards. After the surgical procedure, serum pancreatic amylase and lipase activity will be systematically measured two hours after surgery on postoperative day (POD) 0 and every day at 7 a.m. until POD 5 according to our institutional policy. At our institution, the upper limit of normal for serum pancreatic amylase is 52 U/L and for serum lipase is 60 U/L. Postoperative protocols included the routine measurement of inflammatory markers (white blood cell \[WBC\] count and C-Reactive Protein \[CRP\]). A urine trypsinogen strip test will be done on POD 1. A trypsinogen-2 concentration of more than 50 µg/l is considered a positive test. As routine clinical practice, a post-operative imaging will be scheduled to check for potential surgical morbidity. Abdominal magnetic resonance imaging (MRI) will be assessed on POD 3.

Pancreaticoduodenectomy patients

Eligibility Criteria

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

Study Population

Patients scheduled to receive elective PD (only Kausch-Whipple or Longmire-Traverso) for all kinds of pancreatic disease (benign, malignant or premalignant) will be enrolled, after having signed a proper informed consent. Each patient will undergo PD once checked the presence of a resectable mass as provided by the normal clinical practice through high-quality cross-sectional imaging. Pre-operative management will follow institutional standards, serum pancreatic amylase and lipase activity will be measured as a part of the standard pre-operative evaluation.

You may qualify if:

• Male and females ≥ 18 years;
• Scheduled for elective PD;
• ASA score \< 4;
• High-quality preoperative cross-sectional imaging of the abdomen performed roughly within one month before surgery;
• Upfront or after neoadjuvant therapy surgery is allowed;
• Ability of the subject to understand the character and individual consequences of the clinical trial;
• Written informed consent.

You may not qualify if:

• Patients undergoing emergency surgery;
• Patients with high serum pancreatic amylase or lipase before surgery;
• Chronic use of steroids;
• Informed consent withdrawal;
• Pancreaticogastrostomy (PG);
• Use of octreotide analogs;
• Inability to perform the resection for any reason;
• Total or distal pancreatectomy;
• Need to extend the resection to the pancreas body for any reason.
• Inability to undergo MRI because of contraindications (e.g. claustrophobia, presence of non-MRI-compatible metal implants)

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (1)

Verona University Hospital

Verona, VR, 37134, Italy

Location

Related Publications (5)

• Bannone E, Andrianello S, Marchegiani G, Malleo G, Paiella S, Salvia R, Bassi C. Postoperative hyperamylasemia (POH) and acute pancreatitis after pancreatoduodenectomy (POAP): State of the art and systematic review. Surgery. 2021 Feb;169(2):377-387. doi: 10.1016/j.surg.2020.04.062. Epub 2020 Jul 5.

  PMID: 32641279 BACKGROUND

• Bannone E, Andrianello S, Marchegiani G, Masini G, Malleo G, Bassi C, Salvia R. Postoperative Acute Pancreatitis Following Pancreaticoduodenectomy: A Determinant of Fistula Potentially Driven by the Intraoperative Fluid Management. Ann Surg. 2018 Nov;268(5):815-822. doi: 10.1097/SLA.0000000000002900.

  PMID: 30004917 BACKGROUND

• Partelli S, Tamburrino D, Andreasi V, Mazzocato S, Crippa S, Perretti E, Belfiori G, Marmorale C, Balzano G, Falconi M. Implications of increased serum amylase after pancreaticoduodenectomy: toward a better definition of clinically relevant postoperative acute pancreatitis. HPB (Oxford). 2020 Nov;22(11):1645-1653. doi: 10.1016/j.hpb.2020.03.010. Epub 2020 Apr 11.

  PMID: 32291175 BACKGROUND

• Chen H, Wang W, Ying X, Deng X, Peng C, Cheng D, Shen B. Predictive factors for postoperative pancreatitis after pancreaticoduodenectomy: A single-center retrospective analysis of 1465 patients. Pancreatology. 2020 Mar;20(2):211-216. doi: 10.1016/j.pan.2019.11.014. Epub 2019 Nov 27.

  PMID: 31831390 BACKGROUND

• Loos M, Strobel O, Dietrich M, Mehrabi A, Ramouz A, Al-Saeedi M, Muller-Stich BP, Diener MK, Schneider M, Berchtold C, Feisst M, Hinz U, Mayer P, Giannakis A, Schneider D, Weigand MA, Buchler MW, Hackert T. Hyperamylasemia and acute pancreatitis after pancreatoduodenectomy: Two different entities. Surgery. 2021 Feb;169(2):369-376. doi: 10.1016/j.surg.2020.07.050. Epub 2020 Sep 25.

  PMID: 32981689 BACKGROUND

MeSH Terms

Conditions

Pancreatitis; Pancreatic Fistula; Postoperative Complications

Condition Hierarchy (Ancestors)

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

Study Officials

• Giovanni Marchegiani, MD, PhD

  Universita di Verona

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: June 8, 2021
• Study Start: April 10, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: October 21, 2022

Record last verified: 2021-05

Locations

IT (1)