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

Overview

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.

Interventions

• Procedure Avoid surgical drainage
  Patients who undergo distal pancreatectomy, avoid placing a drain.

Primary outcome measures

• Clinically relevant postoperative pancreatic fistula [Time frame: From first postoperative day until day 30 after surgery]

Secondary outcome measures (12)

• Clavien-Dindo morbidity greater than or equal to 3. [Time frame: From first postoperative day until the ninth month after surgery]
• Reoperation. [Time frame: From first postoperative day until day 90 after surgery]
• Percutaneous drainage. [Time frame: From first postoperative day until day 90 after surgery]
• Abdominal collections [Time frame: From first postoperative day until day 90 after surgery]
• Surgical wound infection. [Time frame: From first postoperative day until day 90 after surgery]
• Delayed gastric emptying. [Time frame: From first postoperative day until day 90 after surgery]
• Postoperative bleeding. [Time frame: From first postoperative day until day 90 after surgery]
• Blood transfusion. [Time frame: From first postoperative day until day 90 after surgery]
• Length of hospital stay [Time frame: From first postoperative day until day 90 after surgery]
• In-hospital mortality. [Time frame: From first postoperative day after surgery.]
• Intensive care admission. [Time frame: From first postoperative day until day 90 after surgery]
• Mortality. [Time frame: From first postoperative day until day 90 after surgery]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Lillemoe KD, Kaushal S, Cameron JL, Sohn TA, Pitt HA, Yeo CJ. Distal pancreatectomy: indications and outcomes in 235 patients. Ann Surg. 1999 May;229(5):693-8; discussion 698-700. doi: 10.1097/00000658-199905000-00012. PMID 10235528
• Balcom JH 4th, Rattner DW, Warshaw AL, Chang Y, Fernandez-del Castillo C. Ten-year experience with 733 pancreatic resections: changing indications, older patients, and decreasing length of hospitalization. Arch Surg. 2001 Apr;136(4):391-8. doi: 10.1001/archsurg.136.4.391. PMID 11296108
• Kleeff J, Diener MK, Z'graggen K, Hinz U, Wagner M, Bachmann J, Zehetner J, Muller MW, Friess H, Buchler MW. Distal pancreatectomy: risk factors for surgical failure in 302 consecutive cases. Ann Surg. 2007 Apr;245(4):573-82. doi: 10.1097/01.sla.0000251438.43135.fb. PMID 17414606
• Sledzianowski JF, Duffas JP, Muscari F, Suc B, Fourtanier F. Risk factors for mortality and intra-abdominal morbidity after distal pancreatectomy. Surgery. 2005 Feb;137(2):180-5. doi: 10.1016/j.surg.2004.06.063. PMID 15674199
• Nathan H, Cameron JL, Goodwin CR, Seth AK, Edil BH, Wolfgang CL, Pawlik TM, Schulick RD, Choti MA. Risk factors for pancreatic leak after distal pancreatectomy. Ann Surg. 2009 Aug;250(2):277-81. doi: 10.1097/SLA.0b013e3181ae34be. PMID 19638926
• Pannegeon V, Pessaux P, Sauvanet A, Vullierme MP, Kianmanesh R, Belghiti J. Pancreatic fistula after distal pancreatectomy: predictive risk factors and value of conservative treatment. Arch Surg. 2006 Nov;141(11):1071-6; discussion 1076. doi: 10.1001/archsurg.141.11.1071. PMID 17116799
• Knaebel HP, Diener MK, Wente MN, Buchler MW, Seiler CM. Systematic review and meta-analysis of technique for closure of the pancreatic remnant after distal pancreatectomy. Br J Surg. 2005 May;92(5):539-46. doi: 10.1002/bjs.5000. PMID 15852419
• Karabicak I, Satoi S, Yanagimoto H, Yamamoto T, Yamaki S, Kosaka H, Hirooka S, Kotsuka M, Michiura T, Inoue K, Matsui Y, Kon M. Comparison of surgical outcomes of three different stump closure techniques during distal pancreatectomy. Pancreatology. 2017 May-Jun;17(3):497-503. doi: 10.1016/j.pan.2017.04.005. Epub 2017 Apr 8. PMID 28411019

Identifiers

NCT: NCT06141044 · PANDREAS21101995

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗