Clinical trial · Interventional

Open Versus Laparoscopic Assisted Pancreaticoduodenectomy

Open Versus Laparoscopic Assisted Pancreaticoduodenectomy: Randomized Control Comparative Prospective Study

NCT05463328CI-TRIAL-00059716unknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Compare open and laparoscopic assisted pancreaticoduodenectomy regarding intraoprative blood loss, organ injury, completion of planned laparoscopic steps, duration and early post operative course of pain, hem stability, oral feeding, leakage(pancreatic, billary and intestinal). ,bleeding, mortality, lymph nodes and safety margins .

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Pancreas Neoplasm	Pancreatic Neoplasm	ALIAS	0.90

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
laparoscopic assisted pancreaticoduodenectomy	Procedure	—	UNRESOLVED
Open pancreaticduodenctomy	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Laparoscopic assisted pancreaticoduodenctomy
description
If inclusion criteria are met ,these group of patients will undergo Laparoscopic assisted pancreaticoduodenctomy.
interventionNames
1. Procedure: laparoscopic assisted pancreaticoduodenectomy
type
ACTIVE_COMPARATOR
label
Open pancreaticduodenctomy
description
criteria are met ,these group of patients will undergo open pancreaticoduodenctomy
interventionNames
1. Procedure: Open pancreaticduodenctomy

Primary outcomes (3)

measure
post operative pain.
timeFrame

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 70 Years

Show eligibility criteria text

Inclusion Criteria:

1. age less than 70 years.
2. resectable tumour,
3. fit for surgery

Exclusion Criteria:

1. patients with jaundice with serum bilirubin above 200mml/dl.
2. patients with bleeding tendency until corrected.
3. patients with advanced and metastatic malignancy.
4. patients with cardiopulmonary diseases.

References

Publications (4)

BACKGROUNDNewhook TE, LaPar DJ, Lindberg JM, Bauer TW, Adams RB, Zaydfudim VM. Morbidity and mortality of pancreaticoduodenectomy for benign and premalignant pancreatic neoplasms. J Gastrointest Surg. 2015 Jun;19(6):1072-7. doi: 10.1007/s11605-015-2799-y. Epub 2015 Mar 24. PMID 25801594
BACKGROUNDErratum to "Cancer statistics, 2021". CA Cancer J Clin. 2021 Jul;71(4):359. doi: 10.3322/caac.21669. Epub 2021 Apr 19. No abstract available. PMID 34232515
BACKGROUNDCorrection to Lancet Gastroenterol Hepatol 2019; 4: 934-47. Lancet Gastroenterol Hepatol. 2020 Mar;5(3):e2. doi: 10.1016/S2468-1253(20)30018-2. No abstract available. PMID 32061329
BACKGROUNDBausch D, Keck T. Minimally Invasive Surgery of Pancreatic Cancer: Feasibility and Rationale. Visc Med. 2018 Dec;34(6):440-443. doi: 10.1159/000495324. Epub 2018 Nov 28. PMID 30675490