Prophylactic Abdominal Drainage vs no Drainage After Distal Pancreatectomy

NCT ID: NCT06141044

Last Updated: 2023-11-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2027-12-31

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.

Detailed Description

A prospective, randomised, multicentre, multicentre, randomised non-inferiority study is designed. The aim is to study whether patients who undergo distal pancreatectomy can benefit from the non-placement of a drain in terms of clinically relevant postoperative pancreatic fistula and Clavien-Dindo morbidity greater than or equal to 3.

Information will be collected for all patients undergoing distal pancreatectomy surgery at the collaborating centres who, upon invitation, voluntarily agree to participate in the study. Those who have agreed to participate, given written consent and meet the inclusion criteria and none of the exclusion criteria will be randomly assigned to one of the following treatment groups:

• Control group: patients who, after distal pancreatectomy, in whom abdominal drainage is placed.
• Intervention group: patients who, after distal pancreatectomy, will be omitted the placement of an abdominal drain.

Following the postoperative pancreatic fistula score according to the DISPAIR criteria, patients included in the present study will be stratified according to the preoperative risk of postoperative pancreatic fistula into: extreme, high, moderate and low.

The standards of surgical technique to be followed in both open and minimally invasive distal pancreatectomy were agreed by consensus.

Each patient will be followed up for 6 months from the time of randomisation (day of surgery).Those responsible for the recruitment and selection of patients for inclusion in the research project belong to the Multidisciplinary Committee of Hepatobiliary and Pancreatic Surgery of each centre. Surgical intervention, postoperative management and perioperative morbidity will be evaluated by the surgeon responsible for the patient. A patient recruitment period of 2 years is estimated. After a follow-up period of 6 months, an analysis of postoperative pancreatic fistula rate, perioperative morbidity, biochemical parameters and quality of life will be performed.

Conditions

Postoperative Pancreatic Fistula; Distal Pancreatectomy; Drainage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Drainage

Patients undergoing distal pancreatectomy with surgical drainage.

Group Type: NO_INTERVENTION

No interventions assigned to this group

No drainage

Patients undergoing distal pancreatectomy without surgical drainage.

Group Type: EXPERIMENTAL

Avoid surgical drainage

Intervention Type: PROCEDURE

Patients who undergo distal pancreatectomy, avoid placing a drain.

Interventions

Avoid surgical drainage

Patients who undergo distal pancreatectomy, avoid placing a drain.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinica Universidad de Navarra, Universidad de Navarra

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fernando Rotellar, MD, PhD

Role: STUDY_DIRECTOR

Clínica Universidad de Navarra

Central Contacts

Fernando Rotellar, MD, PhD

Role: CONTACT

frotellar@unav.es

948255400 ext. 4729

Nuria Blanco

Role: CONTACT

nblancoasen@unav.es

948255400 ext. 4714

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Other Identifiers

PANDREAS21101995

Identifier Type: -

Identifier Source: org_study_id