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

Primary Purpose

Delayed Gastric Emptying

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PPPD (pylorus-preserving pancreaticoduodenectomy)
PPPD (pylorus-preserving pancreaticoduodenectomy) with DJ-pexy
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delayed Gastric Emptying focused on measuring pancreaticoduodenectomy, delayed gastric emptying, duodenojejunopexy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

conventional group

DJ-pexy group

Arm Description

Conventional PPPD

PPPD with additional DJ-pexy to anchor DJ to transverse colon

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Risk factors influencing DGE
Preoperative, intraoperative, and postoperative variables will analyzed statistically between the arms

Full Information

First Posted
December 15, 2015
Last Updated
March 24, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02635399
Brief Title
Impact of Additional DJ (Duodenojejunostomy)-Pexy on Reduction in Delayed Gastric Emptying Following Pylorus-preserving Pancreaticoduodenectomy: A Prospective, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delayed Gastric Emptying
Keywords
pancreaticoduodenectomy, delayed gastric emptying, duodenojejunopexy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional group
Arm Type
Placebo Comparator
Arm Description
Conventional PPPD
Arm Title
DJ-pexy group
Arm Type
Experimental
Arm Description
PPPD with additional DJ-pexy to anchor DJ to transverse colon
Intervention Type
Procedure
Intervention Name(s)
PPPD (pylorus-preserving pancreaticoduodenectomy)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
PPPD (pylorus-preserving pancreaticoduodenectomy) with DJ-pexy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Occurence of clinically relevant DGE
Description
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.
Time Frame
With the first 30days after surgery
Secondary Outcome Measure Information:
Title
Risk factors influencing DGE
Description
Preoperative, intraoperative, and postoperative variables will analyzed statistically between the arms
Time Frame
Within the first 30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang Moo Kang, MD
Phone
82-2-2228-2100
Email
cmkang@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21347870
Citation
Khan AS, Hawkins WG, Linehan DC, Strasberg SM. A technique of gastrojejunostomy to reduce delayed gastric emptying after pancreatoduodenectomy. J Gastrointest Surg. 2011 Aug;15(8):1468-71. doi: 10.1007/s11605-011-1471-4. Epub 2011 Feb 24.
Results Reference
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Impact of Additional DJ (Duodenojejunostomy)-Pexy on Reduction in Delayed Gastric Emptying Following Pylorus-preserving Pancreaticoduodenectomy: A Prospective, Randomized Controlled Trial

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