Impact of Additional DJ (Duodenojejunostomy)-Pexy on Reduction in Delayed Gastric Emptying Following Pylorus-preserving Pancreaticoduodenectomy: A Prospective, Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
Surgical resection in periampullary cancer using pancreaticoduodenectomy is the most important modality in the treatment. In the past, pancreaticoduodenectomy was associated with high morbidity and mortality. However, with the advances in techniques, including perioperative patient management, development of antibiotics, diagnostic radiology, and interventional treatments, pancreaticoduodenectomy is now considered a safe and feasible operation. Postoperative complication rates are reported to be in 10 to 20% in experienced hospitals and operation related mortality is at about 1%. Therefore, surgical treatment for periampullary cancer is actively considered. However, postoperative complications, such as postoperative pancreatic fistula, (POPF) delayed gastric emptying, intraabdominal abscess, and postoperative bleeding, are still serious complications. Among these complications, delayed gastric emptying is considered less critical. However, delayed gastric emptying (DGE) can cause poor oral intake, which in turn, may lead to delay in recovery of postoperative nutritional state and in severe cases, requires insertion of levine tube and long-term fasting. There have been many hypotheses for cause of DGE after pancreaticoduodenectomy, but definite cause have not been discovered yet. With the introduction of pylorus-preserving pancreaticoduodenectomy (PPPD), incidences of DGE were initially reported to have increased. However, results of most randomized comparative studies had concluded that PPPD and PD have no significance in occurence of DGE. One hypothesis for cause of DGE we present here has to do with anatomic positioning of anastomosis site, especially pancreatojejunostomy (PJ) and duodenojejunostomy (DJ), after PPPD. Reconstruction after PPPD positions PJ and DJ close to each other. PJ site is often associated with one of postoperative complications, POPF. POPF may create inflammation around PJ site and pancreatitis, which may lead to severe adhesion around PJ as a secondary change. This adhesion and inflammation may cause DJ, which is located near PJ, to be pulled towards PJ site. When DJ is pulled towards PJ site, distal DJ site can become angulated and gastric contents may not beadle to pass easily. Gastric contents may be stagnated in stomach and thereby causing DGE. Therefore, in this study, we will fixate DJ on transverse colon using sutures, and prevent possibility of angulation of DJ. This additional procedure may reduce occurence of DGE.

Conditions
-----------------
Delayed Gastric Emptying

Intervention / Treatment
-----------------
* Procedure: PPPD (pylorus-preserving pancreaticoduodenectomy)
* Procedure: PPPD (pylorus-preserving pancreaticoduodenectomy) with DJ-pexy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All periampullary pathologic conditions that require PPPD Age ≥20 and ≤80 General performance status: the Karnofsky score> 70% or ECOG 0-1 Exclusion Criteria: Unresectable or locally advanced, metastatic case patients who do not want surgery ASA (American society of anesthesiologists' physical status classification) score: ≥3 patients with drug or alcohol addiction patients showing low compliance patients who not want to involve the clinical trial patients who are unable to read or understand the informed consent, sign a consent form (eg, mental retardation, blindness, illiteracy, foreign, etc.) pylorus can not be preserved Patients undergoing laparoscopic PPPD Additional resection of adjacent organs or vascular resection was performed Previous history of open surgery

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: conventional group<br>Conventional PPPD | Procedure: PPPD (pylorus-preserving pancreaticoduodenectomy)<br>* pylorus-preserving pancreaticoduodenectomy is done in a conventional method. Additional DJ-pexy is performed for experimental group. DJ-pexy is performed by anchoring DJ site to transverse colon so that DJ is fixed to its original position.<br>|
| Experimental: DJ-pexy group<br>PPPD with additional DJ-pexy to anchor DJ to transverse colon | Procedure: PPPD (pylorus-preserving pancreaticoduodenectomy) with DJ-pexy<br>* pylorus-preserving pancreaticoduodenectomy is done in a conventional method. Additional DJ-pexy is performed for experimental group. DJ-pexy is performed by anchoring DJ site to transverse colon so that DJ is fixed to its original position.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of clinically relevant DGE | DGE is defined by International Study Group of Pancreatic Surgery consensus definition. Clinically relevant grade B or C will be recorded and occurrence rate of DGE between the arms will be compared. | With the first 30days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors influencing DGE | Preoperative, intraoperative, and postoperative variables will analyzed statistically between the arms | Within the first 30 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreaticoduodenectomy, delayed gastric emptying, duodenojejunopexy