Clinical trial NCT02635399: Impact of Additional DJ (Duodenojejunostomy)-Pexy on Reduction in Delayed Gastric Emptying Following Pylorus-preserving Pancreaticoduodenectomy: A Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Delayed Gastric Emptying
Keywords: pancreaticoduodenectomy, delayed gastric emptying, duodenojejunopexy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-12-18
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Occurence of clinically relevant DGE
timeFrame: With the first 30days after surgery
Secondary outcomes:
measure: Risk factors influencing DGE
timeFrame: Within the first 30 days after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
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.