Chyle Leak After Pancreatic Surgery
Schlüsselwörter
Abstrakt
Beschreibung
With an incidence of up to 11%, postoperative chyle leak (CL) is a frequent phenomenon after pancreatic surgery, where extensive lymph node dissections are indispensable. Postoperative CL is frequently treated with either medium-chain triglyceride diet (MCT-diet) or total parenteral nutrition (TPN). Ignoring CL and removing the surgical drains irrespective of CL may also be discussed. While dietary restrictions are known to hinder postoperative convalescence and prolong the length of stay at the hospital, recent retrospective data show that leaving CL untreated is not associated with an increased morbidity rate. More precisely, removing the surgical drains irrespective of CL does not result in an increased incidence of CT-guided drainages. However, prospective data on CL after pancreatic surgery do not exist in the literature. Accordingly, the present trial aims to compare treatment of CL with dietary restrictions to removing the surgical drains irrespective of CL.
Termine
Zuletzt überprüft: | 07/31/2018 |
Zuerst eingereicht: | 02/24/2017 |
Geschätzte Einschreibung eingereicht: | 03/13/2017 |
Zuerst veröffentlicht: | 03/14/2017 |
Letztes eingereichtes Update: | 08/12/2018 |
Letztes Update veröffentlicht: | 08/14/2018 |
Tatsächliches Startdatum der Studie: | 05/30/2017 |
Geschätztes primäres Abschlussdatum: | 04/29/2021 |
Voraussichtliches Abschlussdatum der Studie: | 06/29/2021 |
Zustand oder Krankheit
Intervention / Behandlung
Other: Ignoring CL (group A)
Other: Dietary treatment (group B)
Phase
Armgruppen
Arm | Intervention / Behandlung |
---|---|
Experimental: Ignoring CL (group A) Standard care irrespective of CL. | Other: Ignoring CL (group A) Removal of surgical drains despite persistent CL, without dietary restrictions or dietary treatment for CL. |
Active Comparator: Dietary treatment (group B) Dietary treatment with medium-chain triglyceride diet (MCT-diet) until resolution of CL. | Other: Dietary treatment (group B) Dietary treatment with MCT-diet until resolution of CL. |
Zulassungskriterien
Altersberechtigt für das Studium | 18 Years Zu 18 Years |
Studienberechtigte Geschlechter | All |
Akzeptiert gesunde Freiwillige | Ja |
Kriterien | Inclusion Criteria: - Written informed consent - Pancreatic surgery of any kind Exclusion Criteria: - Liver cirrhosis > Child-Pugh grade A - History of portal vein thrombosis - Portal Hypertension Dropout Criteria: - Irresectable Tumor (no surgical resection) - Biochemical leak or postoperative pancreatic fistula (POPF)5 - Serous drainage on POD 5 - Peritoneal carcinomatosis - Portal vein thrombosis - Postoperative bile leak - Drain volume >1000ml on POD5 |
Ergebnis
Primäre Ergebnismaße
1. Postoperative morbidity [30 days postoperatively]
Sekundäre Ergebnismaße
1. Length of stay at the hospital [90 days postoperatively]
2. Time until drain removal [30 days postoperatively]
3. Readmission to the hospital [90 days postoperatively]
4. Weight change [The day before surgery until postoperative day 10]
5. Body mass index (BMI) change [The day before surgery until postoperative day 10]
6. International normalized ration (INR) change [The day before surgery until postoperative day 10]
7. Albumin change [The day before surgery until postoperative day 10]
8. Postoperative cortisol level [8 days postoperatively]
9. Freiburg index of patient satisfaction [Postoperative day 10]