First-day Versus Early Drain Removal Following PD: a Randomized Controlled Trial

NCT06468917 | Recruiting DMC

• 1 other identifier: Cdcpederzoli
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

Pancreatic surgery is a complex discipline with a high risk of post-operative morbidity such as pancreatic fistula (POPF) with variable impact on clinical outcome. Controversies on ID placement have emerged from both randomized and non-randomized clinical studies investigating its possible role in increasing POPF and postoperative morbidity. The optimal timing for drain removal after PD is still a subject of debate: most studies have shown that outcomes are best when ID are removed in postoperative day (POD) 3 when POPF is excluded. AIM we aim to compare postoperative surgical outcomes after PD in patients with low/medium risk for POPF (ISGPS risk class A-B-C), who undergo POD1 drains removal versus POD3 removal. Primary aim: 1) grade B/C POPF; 2) post-pancreatectomy hemorrhage (PPH). Secondary aims: occurrence of fluid collection, sepsis, SSI, need for reintervention, length of stay, CD\>3, 90 days mortality, re-admission. Study Design: This is a randomized, controlled, open-label study. All patients will be randomized on POD1, using computer-generated randomization codes. Group A: Drain removal on POD 1 (in case of POD 1 DFA\< 300 U/L) Group B: Drain removal on POD 3 (in case of POD 1 DFA\< 300 U/L)

Conditions

Pancreas Fistula Abdominal Drains

Keywords

pancreatic fistula pancreaticoduodenectomy drain fluid amylase

Outcome Measures

Primary Outcomes (1)

• occurrence of one or more pancreas-specific complications

  complications are defined according to ISGPS as:1) grade B/C POPF; 2) post-pancreatectomy hemorrhage (PPH).

  up to 90 days after surgery

Secondary Outcomes (1)

• occurrence of general post operative complications

  up to 90 days after surgery

Study Arms (2)

Drain removal on POD 1

ACTIVE COMPARATOR

in case of POD 1 DFA\< 300 U/L

Behavioral: 1st day removal of abdominal drain

Drain removal on POD 3

ACTIVE COMPARATOR

in case of POD 1 DFA\< 300 U/L

Behavioral: 1st day removal of abdominal drain

Interventions

1st day removal of abdominal drain BEHAVIORAL

once POPF is excluded in middle-low risk pancreatic resection, abdominal drains can be removed

Also known as: 3rd day removal of abdominal drains

Drain removal on POD 1; Drain removal on POD 3

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients (age ≥ 18 or \< 85 years) undergoing elective pancreaticoduodenectomy providing informed consent.
• Intraoperative low to moderate risk for POPF (ISGPS class A-B-C)
• POD 1 DFA \< 300U/L

You may not qualify if:

• Age \<18 or \>85
• Patients with high risk of developing pancreatic fistula (ISGPS class D)
• Intraoperative positioning of external or internal pancreatic stent
• POD 1 DFA ≥300
• Sinister appearance of drain effluent (defined as dark brown to clear "spring water" fluid that looks like pancreatic juice contaminated) as mentioned in literature3-22
• Early post-pancreatectomy hemorrhage
• Intraoperative conditions different from POPF risk, requiring prolonged intrabdominal drains
• Previous bilio/pancreatic surgery
• Allergy to drain materials
• Significant coagulation disorders
• Patients unable to provide informed consent.
• Clinical suspect of another surgery-related fistula different than POPF

Sponsors & Collaborators

• Casa di Cura Dott. Pederzoli: lead
• University of Padova: collaborator

Study Sites (1)

Cdcpederzoli

Peschiera del Garda, Verona, 37019, Italy

RECRUITING

Study Officials

• isabella frigerio, MD

  Casa di Cura Dott. Pederzoli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

isabella frigerio, MD

CONTACT

00390456449187; isabella.frigerio@ospedalepederzoli.it

giovanni butturini, MD

CONTACT

00390456449283; butturinichirurgo@gmail.com

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: MD PhD

Model Details: This is a randomized, controlled, open-label study. The Study will be registered in the International Standard Randomized Controlled Trial Registry. All patients encountering inclusion criteria will be randomized on POD1, using computer-generated randomization codes. Group A: Drain removal on POD 1 (in case of POD 1 DFA\< 300 U/L) Group B: Drain removal on POD 3 (in case of POD 1 DFA\< 300 U/L)

Study Record Dates

• First Submitted: June 16, 2024
• First Posted: June 21, 2024
• Study Start: June 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 30, 2026
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

IT (1)