Clinical trial NCT06141044: Prophylactic Abdominal Drainage vs no Drainage After Distal Pancreatectomy
Official title: PANDREAS. Prophylactic Abdominal Drainage vs no Drainage After Distal Pancreatectomy: a Multicentre Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Pancreatic Fistula
Distal Pancreatectomy
Drainage
Keywords: Postoperative pancreatic fistula
Distal Pancreatectomy
Intraoperative Drainage
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Clinically relevant postoperative pancreatic fistula
timeFrame: From first postoperative day until day 30 after surgery
Secondary outcomes:
measure: Clavien-Dindo morbidity greater than or equal to 3.
timeFrame: From first postoperative day until the ninth month after surgery
measure: Reoperation.
timeFrame: From first postoperative day until day 90 after surgery
measure: Percutaneous drainage.
timeFrame: From first postoperative day until day 90 after surgery
measure: Abdominal collections
timeFrame: From first postoperative day until day 90 after surgery
measure: Surgical wound infection.
timeFrame: From first postoperative day until day 90 after surgery
measure: Delayed gastric emptying.
timeFrame: From first postoperative day until day 90 after surgery
measure: Postoperative bleeding.
timeFrame: From first postoperative day until day 90 after surgery
measure: Blood transfusion.
timeFrame: From first postoperative day until day 90 after surgery
measure: Length of hospital stay
timeFrame: From first postoperative day until day 90 after surgery
measure: In-hospital mortality.
timeFrame: From first postoperative day after surgery.
measure: Intensive care admission.
timeFrame: From first postoperative day until day 90 after surgery
measure: Mortality.
timeFrame: From first postoperative day until day 90 after surgery
measure: Readmission.
timeFrame: From first postoperative day until day 90 after surgery
measure: To study the role of serum amylase in the development of postoperative pancreatic fistula.
timeFrame: From first postoperative day until the fifth day after surgery
measure: To study the role of amylase production in drainage in the development of postoperative pancreatic fistula.
timeFrame: From first postoperative day until the fifth day after surgery
measure: To study the role of biochemical parameters C-Reactive Protein in the development of postoperative pancreatic fistula.
timeFrame: From first postoperative day until the fifth day after surgery
measure: To study the role of Neutrophil-Lymphocyte Ratio (NLR) in the development of postoperative pancreatic fistula.
timeFrame: From first postoperative day until the fifth day after surgery
measure: To identify subgroups of patients according to their risk for postoperative pancreatic fistula
timeFrame: From first postoperative day until the fifth day after surgery
measure: To analyse the quality of life of patients undergoing distal pancreatectomy
timeFrame: From first postoperative day until the ninth month after surgery
measure: To examine the relevance of the neutrophil-lymphocyte ratio in the exclusion of postoperative pancreatic fistula after distal pancreatectomy.
timeFrame: From first postoperative day until the fifth day after surgery
measure: To compare the quality of life of patients who undergo distal pancreatectomy according to the placement or non-placement of an intraoperative drain
timeFrame: From first postoperative day until the ninth month after surgery
measure: To compare the quality of life of patients who undergo distal pancreatectomy according to the placement or non-placement of an intraoperative drain
timeFrame: From first postoperative day until ninth month after surgery
measure: To compare the quality of life of patients who undergo distal pancreatectomy according to the placement or non-placement of an intraoperative drain
timeFrame: From first postoperative day until ninth month after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Clínica Universidad de Navarra
name: Fernando Rotellar, MD, PhD
role: STUDY_DIRECTOR
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