Prophylactic Abdominal Drainage vs no Drainage After Distal Pancreatectomy

NCT06141044 | Not Yet Recruiting DMC

• 1 other identifier: PANDREAS21101995
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief Summary

Postoperative pancreatic fistula (POPF) is a major source of morbidity and mortality after pancreatic resection, especially after distal pancreatectomy (PD). Today, POPF remains one of the main causes of hospital length of stay and healthcare costs. Numerous surgical techniques have been tested to reduce its incidence without success, so the current standard for the management of POPF, and the avoidance of associated complications, is intraoperative drain placement. However, surgically placed drains are not without risk. In recent years many studies, mostly retrospective, have attempted to determine whether omission of prophylactic drainage is associated with increased morbidity. These studies suggest that patients may benefit from not having a drain placed. This evidence challenges standard practice and the debate of whether or not to place a drain after distal pancreatectomy remains open. The investigators designed a prospective multicentre randomised non-inferiority study to determine whether prophylactic intraoperative drainage is associated with a lower morbidity rate after distal pancreatectomy.

Conditions

Postoperative Pancreatic Fistula; Distal Pancreatectomy; Drainage

Keywords

Postoperative pancreatic fistula; Distal Pancreatectomy; Intraoperative Drainage

Outcome Measures

Primary Outcomes (1)

• Clinically relevant postoperative pancreatic fistula

  The investigators define a clinically relevant pancreatic fistula following the 2016 update of the International Study Group (ISGPS) definition. According to this, a Clinically Relevant Postoperative Pancreatic Fistula refers to a grade B or C. Grade B requires a change in the postoperative management; drains are either left in place \>3 weeks or repositioned through endoscopic or percutaneous procedures. Grade C postoperative pancreatic fistula refers to those postoperative pancreatic fistula that require reoperation or lead to single or multiple organ failure and/or mortality attributable to the pancreatic fistula.

  From first postoperative day until day 30 after surgery

Secondary Outcomes (23)

• Clavien-Dindo morbidity greater than or equal to 3.

  From first postoperative day until the ninth month after surgery

• Reoperation.

  From first postoperative day until day 90 after surgery

• Percutaneous drainage.

  From first postoperative day until day 90 after surgery

• Abdominal collections

  From first postoperative day until day 90 after surgery

• Surgical wound infection.

  From first postoperative day until day 90 after surgery

Study Arms (2)

Drainage

NO INTERVENTION

Patients undergoing distal pancreatectomy with surgical drainage.

No drainage

EXPERIMENTAL

Patients undergoing distal pancreatectomy without surgical drainage.

Procedure: Avoid surgical drainage

Interventions

Avoid surgical drainage PROCEDURE

Patients who undergo distal pancreatectomy, avoid placing a drain.

No drainage

Eligibility Criteria

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

You may qualify if:

• Adult patients (over 18 years of age) undergoing elective distal pancreatectomy surgery for any indication, with or without splenectomy, minimally invasive or open. It is not necessary to integrate gender perspective as it is not relevant and there is no influence on the results of POPF or morbidity.
• Signed informed consent was obtained from each of the patients included in the study.

You may not qualify if:

• Patients undergoing distal pancreatectomy as a secondary procedure
• Additional liver, gastric or colonic resection
• Pregnancy
• Participation in another study
• History of previous surgery involving the pancreas
• Patients with American Society of Anaesthesiologists classification 4
• Arterial resection other than the splenic artery

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Related Publications (28)

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Study Officials

• Fernando Rotellar, MD, PhD

  Clínica Universidad de Navarra

  STUDY DIRECTOR

Central Study Contacts

Fernando Rotellar, MD, PhD

CONTACT

948255400; frotellar@unav.es

Nuria Blanco

CONTACT

948255400; nblancoasen@unav.es

Study Design

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

Model Details: National, randomised, prospective, non-inferiority, multicentre clinical trial.To comparatively evaluate the rate of postoperative pancreatic fistula in patients undergoing distal pancreatectomy in one group with and one group without surgical drainage.

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: November 21, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will become available at the completion of the study and will remain available from that moment onward.
• Access Criteria: Upon request to researchers