Clinical trial NCT03277625: Modified Reconstruction for Pancreatic Head Resection
Official title: Safety and Efficacy of Modified Single-loop Omega-shaped Reconstruction After Pancreaticoduodenectomy in Patients With High-risk Pancreas
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreaticoduodenal; Fistula
Keywords: pancreaticoduodenectomy
Lead sponsor: St. Josef Hospital Bochum
Sponsor class: OTHER
First posted: 2017-09-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 98
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients undergoing elective and emergency pancreaticoduodenectomy irrespective of diagnosis. the typical Patient is an obese, old, has a small pancreatic lesion, either cystic or solid, not leading to obstruction of the pancreatic duct or the biliary duct.

Brief summary: This observational study aims to prove the safety and efficacy of a modified method of reconstruction after pancreatic head resection utilizing a single Omega shaped intestinal Loop with an additional anastomosis between the pancreatic and biliary anstomoses. This simple and fast method is expected to provide the advantages of a double-loop reconstruction without adding time and difficulty to the reconstruction process during pancreaticoduodenectomy. The additional intestinal anastomosis should allow Diversion of pancreatic Juice from bile thus reducing the severity of possible postoperative pancreatic Fistula, especially in the subgroup of patients undergoing a pancreaticoduodenectomy and having a high-risk pancreatic remnant, i.e. very soft, fragile and fatty pancreas with a tiny, non-dilated pancreatic main duct. The Primary Point of the study ist the severity of postoperative pancreatic Fistula, as well as the total rate of severe postoperative complications, defined as Grade 3b or more according to the classification of Dindo-Clavien.

Detailed description: Postoperative pancreatic fistula (POPF) is the most common and specific complication of pancreaticoduodenectomy (PD) with reported rates of over 20% even at high-volume centers. POPF may cause life-threatening secondary complications such as postpancreatectomy hemorrhage (PPH), intraabdominal abscess, and sepsis, leading to increased costs, prolonged hospital stay as well as to delayed chemotherapy in oncologic patients.

A myriad of innovations in surgical technique has been introduced over the last several decades in order to reduce the rate and severity of POPF. One of these includes the double-loop (DL) reconstruction with isolated Roux-en-Y loops for the pancreatic and biliary anastomoses. It was first described in 1976 by Machado and has afterwards been applied by many surgeons in different variations. The method is based on the empirical hypothesis that diverting bile away from pancreatic juice may prevent their mutual activation and thus decrease their aggressiveness and detrimental effect on the pancreaticojejunostomy (PJ). Theoretically, reduction in the rate and severity of POPF should be expected. Some randomized controlled trials (RCT) reported decreased severity of POPF and lower rates of associated morbidity, whereas others failed to confirm these positive results. A substantially prolonged duration of surgery was observed in most of the studies.

In order to reduce the rate and severity of POPF without prolonging duration of surgery, we introduced in 2015 a new method of reconstruction during PD using a single long intestinal loop with a side-to-side anastomosis between the afferent and efferent limbs of the hepaticojejunostomy (HJ) similar to a Braun anastomosis in a Billroth II resection. It aimed at increasing the distance between the pancreatic and biliary anastomotic sites and facilitating isolated flow of bile and pancreatic secretions in a simple, fast and straightforward manner without the need for a time-consuming and sometimes technically challenging DL reconstruction.

This study aims to reveal how the new modified single-loop (mSL) method of reconstruction compares to the conventional single loop (SL) and DL methods in terms of severity and rate of POPF as well as associated major complications after PD in high-risk patients with a soft pancreatic remnant and a small pancreatic duct.

Eligibility criteria: Inclusion Criteria:

* pancreaticoduodenectomy
* soft, fragile or fatty pancreatic remnant combined with pancreatic duct \<3mm

Exclusion Criteria:

* soft pancreas, but large pancreatic duct\>3mm
* small pancreatic duct \<3mm, but hard pancreatic remnant

Primary outcomes:
measure: Severity of postoperative pancreatic fistula
timeFrame: from postoperative day 3 until postoperative day 30
Secondary outcomes:
measure: Major postoperative complications
timeFrame: postoperative days 1 to 30
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Department of Surgery, St. Josef Hospital, Ruhr University of Bochum
state: NRW
Study officials:
References: